Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL2512Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00195451000003), received between Jun 14, 2024 and Aug 12, 2026 — classified as 4 deaths, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• DeathAug 12, 2026Difficult to Advance

  A Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) 2.5 x 12 mm catheter was used to treat a 95% stenosed mid left anterior descending (LAD) lesion with a 90-degree turn at the location of the calcific lesion. The physician attempted to cross the lesion with the IVL catheter; however, the catheter would not cross. A 2.5 mm non-complaint (NC) Sapphire balloon was used to pre-dilate the lesion, and the IVL catheter was subsequently reinserted. During the second cycle of IVL treatment in the LAD, a perforation occurred.The IVL catheter was removed, and fluoroscopy and angiography revealed a perforation at the site of the bifurcation lesion between the LAD and Diag 1, where eccentric plaque was present. An urgent drug-eluting stent (DES) was delivered to treat the perforation. No post-dilation was performed following IVL treatment, as the patient was unstable and initial angiography following IVL identified the perforation.A bedside echocardiogram identified a pericardial effusion, and pericardiocentesis was performed with approximately 200 mL removed from the pericardial sac. Protamine was administered, and internal tamponade was performed with a coronary balloon. Fluoroscopy sub

  Patient problems: Cardiac Arrest; Perforation of Vessels; Pericardial Effusion

  MAUDE report 50227732 ↗
• InjuryJul 1, 2026Insufficient Device Problem Information; Material Split, Cut or Torn

  A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A HIGHLY CALCIFIED LESION. THE PHYSICIAN REPORTED THAT THE FIRST DEVICE (B)(6) / EXPERIENCED BALLOON LOSS OF PRESSURE AFTER APPROXIMATELY 40 PULSES DELIVERED AT 4 ATMOSPHERES (ATM). A SECOND IVL CATHETER (B)(6) / MDR#3015053858-2026-00071) WAS SUBSEQUENTLY USED; HOWEVER, THIS DEVICE ALSO EXPERIENCED A BALLOON LOSS OF PRESSURE AFTER APPROXIMATELY 80 PULSES DELIVERED AT 4 ATM. IT WAS REPORTED THAT A VESSEL RUPTURE OCCURRED HOWEVER; IT IS UNKNOWN WHEN THE VESSEL RUPTURE OCCURRED IN RELATION TO IVL TREATMENT. IN ADDITION, IT WAS NOT REPORTED HOW THE VESSEL RUPTURE WAS TREATED. IT WAS NOTED THAT THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE CASE. ADDITIONAL INFORMATION PROVIDED ON 17JUN2026, CONFIRMED THAT THE DEVICE WAS IDENTIFIED AS A 2.5 C2+ (LOT #04A250321B). ADDITIONALLY, IT WAS NOTED THAT THE PERFORATION WAS SUCCESSFULLY TREATED WITH A COVERED STENT, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 25686087 ↗
• InjuryJul 1, 2026Insufficient Device Problem Information; Material Split, Cut or Torn

  A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A HIGHLY CALCIFIED LESION. THE PHYSICIAN REPORTED THAT THE FIRST DEVICE (B)(6) / MDR#3015053858-2026-00070) EXPERIENCED BALLOON LOSS OF PRESSURE AFTER APPROXIMATELY 40 PULSES DELIVERED AT 4 ATMOSPHERES (ATM). A SECOND IVL CATHETER (B)(6) / WAS SUBSEQUENTLY USED; HOWEVER, THIS DEVICE ALSO EXPERIENCED A BALLOON LOSS OF PRESSURE AFTER APPROXIMATELY 80 PULSES DELIVERED AT 4 ATM. IT WAS REPORTED THAT A VESSEL RUPTURE OCCURRED HOWEVER; IT IS UNKNOWN WHEN THE VESSEL RUPTURE OCCURRED IN RELATION TO IVL TREATMENT. IN ADDITION, IT WAS NOT REPORTED HOW THE VESSEL RUPTURE WAS TREATED. IT WAS NOTED THAT THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE CASE. ADDITIONAL INFORMATION PROVIDED ON 17JUN2026, CONFIRMED THAT THE DEVICE WAS IDENTIFIED AS A 2.5 C2+ (LOT #04A250321B). ADDITIONALLY, IT WAS NOTED THAT THE PERFORATION WAS SUCCESSFULLY TREATED WITH A COVERED STENT, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 25686086 ↗
• InjuryMay 22, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED DURING A PROCEDURE TO TREAT A LESION IN THE CORONARY ARTERY. THE PHYSICIAN WAS UNABLE TO CROSS A HEAVILY CALCIFIED LESION WITH A 2.5 MM SHOCKWAVE C2+ CORONARY IVL BALLOON DESPITE MULTIPLE PRE-DILATATION ATTEMPTS WITH 2.5 MM AND 3.0 MM NON-COMPLAINT (NC) AND REGULAR BALLOONS. THE DEVICE HAD BEEN PREPPED SUCCESSFULLY, BUT THE CATHETER SHAFT KINKED DURING ADVANCEMENT WITH FORWARD PRESSURE EVEN THOUGH NO RESISTANCE WAS FELT. THE KINK WAS LOCATED VERY CLOSE TO THE CATHETER HUB. THERE WAS NO DETACHMENT NOR DEVICE SEPARATION INSIDE THE PATIENT. SUBSEQUENTLY, A 3.0 MM SHOCKWAVE C2+ CORONARY IVL BALLOON (MDR# 3015053858-2026-00049) WAS USED AND THIS DEVICE ALSO COULD NOT CROSS THE SAME LESION VIA RADIAL ACCESS. NO RESISTANCE WAS ENCOUNTERED WHILE TRACKING THE CATHETER OVER THE GUIDEWIRE OR THROUGH THE SHEATH. A BALLOON POSITIONED WITHIN THE LESION ALSO COULD NOT CROSS THE LESION. IT WAS REPORTED THAT A DISSECTION OCCURRED WHEN A WIGGLE WIRE PERFORATED THE ARTERY WALL AT THE DISTAL END - AN EVENT THE PHYSICIAN ATTRIBUTES TO THE WIRE AND NOT TO THE SHOCKWAVE IVL DEVICE SINCE THE DEVICE WAS NOT

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 25262394 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST-MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) CORONARY C2+ WAS USED TO TREAT A MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A TOTAL OF 100 IVL PULSES WERE DELIVERED AT 6 ATM. MULTIPLE SCORING/CUTTING BALLOONS WERE USED FOR PRE AND POST DILATATION. THERE WAS NO REPORTED IVL DEVICE MALFUNCTION. A YEAR AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA SYMPTOMS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON THE SAME DAY AND WAS TRANSPORTED TO AN OUTSIDE HOSPITAL AND UNDERWENT LEFT HEART CATHETERIZATION WITH RESULTS OF 100% OCCLUSION OF THE LAD STENT. A LARGE CLOT BURDEN WAS OBSERVED AND POST CLOT THROMBECTOMY WAS PERFORMED. BALLOON ANGIOPLASTY WAS PERFORMED OF A PREVIOUSLY DEPLOYED LAD STENT. THERE WAS A MODERATELY SEVERE LESION IN THE RIGHT VENTRICLE (RV) AND MILD IN-SENT RESTENOSIS OF THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS RESTARTED ON 75MG OF PLAVIX. CARDIOLOGY RECOMMENDED A LIFE VEST FOR THE PATIENT. THE PATIENT WAS DISCHARGED IN STABLE CONDITION TWO DAYS LATER. THE CLINICAL SITE DETERMINED THAT THE ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) S

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 23493531 ↗
• InjuryNov 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE PRE-MARKET FORWARD CAD IDE CLINICAL STUDY. THREE SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS AND ONE SHOCKWAVE JAVELIN PRE-MARKET CORONARY IVL CATHETER WERE USED TO TREAT A SEVERE CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS REPORT PERTAINS TO THE FIRST C2+ CATHETER. REFER TO (B)(6) (MDR# 3015053858-2025-00125) FOR THE SECOND C2+ CATHETER AND (B)(6) (MDR #3015053858-2025-00126) FOR THE THIRD C2+ CATHETER. FOR THE FIRST C2+ CATHETER, 90 IVL PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATM BEFORE A BALLOON RUPTURE OCCURRED. A SECOND C2+ CATHETER WAS USED TO DELIVER 120 IVL PULSES AT 4 ATM. FOR THE THIRD C2+ CATHETER, 120 IVL PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATM. THE LAST CATHETER USED TO TREAT THE LESION WAS THE PRE-MARKET JAVELIN CORONARY IVL CATHETER WHICH SUCCESSFULLY DELIVERED 120 PULSES. THERE WAS NO IVL MALFUNCTION REPORTED FOR ANY OF THE OTHER CATHETERS USED. A DISSECTION WAS NOTED AFTER THE USE OF THE SECOND C2+ IVL CATHETER AND WAS TREATED SUCCESSFULLY BY STENTING. THE CLINICAL SITE DETERMINED THAT THE DISSECTION WAS NOT RELATED TO THE IVL DEVICE AND DEFINITE TO THE PROCEDURE. AFTER TH

  Patient problems: Myocardial Infarction

  MAUDE report 23469446 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS EVENT WAS REPORTED FROM THE SHOCKWAVE POST MARKET EMPOWER CAD STUDY. THE DATE OF SUBJECT'S INDEX PROCEDURE WAS ON (B)(6) 2024. THE SUBJECT HAD A LESION WITH 90% STENOSIS AND MODERATE CALCIFICATION. PRE-DILATATION WAS PERFORMED USING SCORING/CUTTING BALLOONS BUT WAS UNSUCCESSFUL IN DILATING THE LESION. SUBSEQUENTLY, POST-DILATATION WAS CARRIED OUT FOLLOWING THE USE OF SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. A MEDTRONIC ONYX FRONTIER RX DRUG-ELUTING STENT (DES) WAS SUCCESSFULLY DELIVERED TO TARGET LESION (TL1) DURING THE INDEX PROCEDURE. POST-STENT DILATION WAS PERFORMED, ACHIEVING A FINAL RESIDUAL STENOSIS WAS 0%. THE SUBJECT'S ANGINA SYMPTOMS BEGAN ON (B)(6) 2025, AND SHE PRESENTED TO THE EMERGENCY DEPARTMENT THE SAME DAY. SUBSEQUENTLY, THE SUBJECT WAS TRANSPORTED TO AN OUTSIDE HOSPITAL FOR CARDIAC CATHETERIZATION. THE SUBJECT UNDERWENT LEFT HEART CATHETERIZATION, REVEALING A 100% OCCLUSION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) STENT, ALONG WITH A LARGE CLOT BURDEN. THE PATIENT UNDERWENT CLOT THROMBECTOMY AND BALLOON ANGIOPLASTY OF THE PREVIOUSLY DEPLOYED LAD STENT. FINDINGS INCLUDED A MODERATELY SEVERE LESION IN THE RIGHT VENTRICLE (RV) AND MIL

  Patient problems: Angina; Obstruction/Occlusion; Restenosis; Thrombosis/Thrombus

  MAUDE report 22878096 ↗
• InjuryJun 19, 2025Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn; Difficult to Remove; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.5MM NON-SHOCKWAVE COMPLIANT BALLOON WAS USED FOR PRE-DILATION AND RUPTURED DURING THE PROCEDURE FOLLOWED BY IVL. DURING THE PROCEDURE, THE IVL BALLOON RUPTURED WHILE FULLY INFLATED. DUE TO SEVERE CALCIFICATION, A PORTION OF THE BALLOON DETACHED AND BECAME LODGED IN THE ARTERY. DESPITE MULTIPLE EFFORTS TO RETRIEVE THE BALLOON THROUGH BOTH ENDOVASCULAR AND OPEN-HEART METHODS, RETRIEVAL WAS UNSUCCESSFUL. THE PATIENT UNDERWENT EMERGENT BYPASS SURGERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS CURRENTLY RECOVERING, ALTHOUGH THE IVL BALLOON REMAINS IN PLACE. NO PATIENT DEMOGRAPHICS OR MEDICAL INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. SHOCKWAVE MEDICAL IS ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22290140 ↗
• InjuryJun 11, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND GOT STUCK. IT WAS REPORTED THAT THE SHAFT OF THE CATHETER WAS LODGED IN THE PATIENT'S AORTA, AND THE BALLOON REMAINED STUCK IN THE LAD. THE PATIENT HAD A PRIOR LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT, WHICH WAS SUCCESSFULLY REOPENED DURING THE PROCEDURE. IT WAS REPORTED THAT DUE TO THE BALLOON BEING TRAPPED IN THE LAD, THE CLINICAL TEAM PROCEEDED TO INTERVENE ON THE LIMA AND PLACED A STENT IN THE LEFT MAIN ARTERY TO ENSURE CONTINUED BLOOD FLOW AND VESSEL PATENCY. ADDITIONAL INFORMATION WAS PROVIDED ON MAY 23,2025 INDICATING THAT A 7F CATHETER WAS USED FOR DEVICE DELIVERY AND THAT THE DETACHMENT OCCURRED INTRAPROCEDURAL. IT WAS ALSO NOTED THAT THE BALLOON WAS FULLY DEFLATED PRIOR TO THE ATTEMPTED REMOVAL. AFTER THE DETACHMENT WAS OBSERVED, A SNARE WAS USED TO RETRIEVE THE LODGED SHAFT OF THE CATHETER, BUT EFFORTS WERE UNSUCCESSFUL. THE SMALL PIECE REMAINS IN THE PATIENT AND IS EXPECTED TO BECOME ENDOTHELIALIZED OVER TIME. THE PATIENT WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22188680 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE OBTUSE MARGINAL ARTERY BRANCH OF THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY (LCX). MULTIPLE SCORING/CUTTING BALLOONS WERE USED FOR PRE-DILATATION, POST-DILATATION, AND POST-STENT DILATATION OF THE VESSEL. THE 2.5 MM C2+ IVL CATHETER WAS USED TO DELIVER 120 PULSES AT MAX INFLATION OF 6ATM WITH NO ALLEGED PRODUCT MALFUNCTION. A DRUG ELUTING STENT (DES) WAS PLACED TO COMPLETE THE PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A NON-Q-WAVE MYOCARDIAL INFARCTION (MI). THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED THE PERIPROCEDURAL MI WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE CEC REVIEWED THE FILM AND NOTED LOSS OF SIDE BRANCH. IT WAS DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THERE WAS NO OTHER PATIENT SEQUELAE REPORTED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE INDEX PROCEDURE. APPROXIMATELY 3 WEEKS POST-PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH NON-CARDIAC CHE

  Patient problems: Myocardial Infarction

  MAUDE report 21470976 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RAMUS BRANCH. MULTIPLE NON-COMPLIANT BALLOONS WERE USED FOR PRE-DILATATION, POST-DILATATION, AND POST-STENT DILATATION OF THE VESSEL. THE 2.5MM C2+ IVL CATHETER WAS USED TO DELIVER 120 PULSES AT MAX INFLATION OF 6ATM WITH NO ALLEGED PRODUCT MALFUNCTION. A DRUG ELUTING STENT (DES) WAS PLACED TO COMPLETE THE PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION (MI). THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED THE PERIPROCEDURAL MI WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE CEC REVIEWED THE FILM AND NOTED INCOMPLETE REVASCULARIZATION BUT WITH NO ANGIOGRAPHIC COMPLICATIONS. IT WAS ALSO NOTED THAT THE PATIENT'S CARDIAC TROPONIN LEVELS MEASURED 70 TIMES THE UPPER LIMIT WITHING 48 HOURS OF THE PROCEDURE. IT WAS DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THERE WAS NO OTHER PATIENT SEQUALAE REPORTED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE INDEX PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 21470975 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-COMPLIANT BALLOON WAS USED TO PRE-DILATE THE VESSEL. THE FIRST 2.5MM C2+ IVL CATHETER (REFERENCE MDR# 3015053858-2025-00029) WAS USED WHICH DELIVERED 30 PULSES AT MAX INFLATION OF 4ATM BEFORE THE BALLOON RUPTURED. A SECOND 2.5MM C2+ IVL CATHETER (REFERENCE MDR# 3015053858-2025-00028) WAS USED WHICH SUCCESSFULLY DELIVERED 120 PULSES AT MAX INFLATION OF 4ATM WITH NO ALLEGED PRODUCT MALFUNCTION. A DRUG ELUTING STENT (DES) WAS PLACED AND MULTIPLE NON-COMPLIANT BALLOONS WERE USED FOR POST-STENT DILATION TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION (MI). THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED THE PERIPROCEDURAL MI WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE CEC NOTED ELEVATED CK-MB LEVELS ABOVE TEN TIMES THE UPPER LIMIT WITHIN 48 HOURS OF THE PROCEDURE AS WELL AS SIDE BRANCH OCCLUSION WITH NO NEW Q WAVES. IT WAS DETERMINED THAT THE MI WAS POSSIBLY

  Patient problems: Myocardial Infarction

  MAUDE report 21417481 ↗
• InjuryFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-COMPLIANT BALLOON WAS USED TO PRE-DILATE THE VESSEL. THE FIRST 2.5MM C2+ IVL CATHETER WAS USED WHICH DELIVERED 30 PULSES AT MAX INFLATION OF 4ATM BEFORE THE BALLOON RUPTURED. A SECOND 2.5MM C2+ IVL CATHETER (REFERENCE MDR#: 3015053858-2025-00028) WAS USED WHICH SUCCESSFULLY DELIVERED 120 PULSES AT MAX INFLATION OF 4ATM WITH NO ALLEGED PRODUCT MALFUNCTION. A DRUG ELUTING STENT (DES) WAS PLACED AND MULTIPLE NON-COMPLIANT BALLOONS WERE USED FOR POST-STENT DILATION TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A NON-Q-WAVE MYOCARDIAL INFARCTION (MI). THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED THE PERIPROCEDURAL MI WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE CEC NOTED ELEVATED CK-MB LEVELS ABOVE TEN TIMES THE UPPER LIMIT WITHIN 48 HOURS OF THE PROCEDURE AS WELL AS SIDE BRANCH OCCLUSION WITH NO NEW Q WAVES. IT WAS DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFIN

  Patient problems: Myocardial Infarction

  MAUDE report 21417480 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX). MULTIPLE NON-SHOCKWAVE BALLOONS WERE USED TO PRE-DILATE THE VESSEL. 70 IVL PULSES WERE SUCCESSFULLY DELIVERED AT A MAX OF 6 ATM. TWO DES STENTS WERE PLACED IN THE LCX FOLLOWED BY POST-DILATATION WITH MULTIPLE NON-SHOCKWAVE BALLOON CATHETERS. THERE WAS NO PATIENT SEQUALAE REPORTED. ADDITIONALLY, THERE WAS NO IVL MALFUNCTION REPORTED. THE SITE REPORTED THE PATIENT PRESENTED WITH A NON-Q-WAVE NSTEMI ATTRIBUTABLE TO THE TARGET VESSEL ONE DAY POST INDEX PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE MYOCARDIAL INFARCTION (MI). THE CEC DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THEY NOTED THAT THERE WAS NO SIDE BRANCH OCCLUSION AND THAT THE TROPONIN LEVELS WERE GREATER THAN 70 X UPPER LIMIT OF NORMAL (ULN) WITHIN 48 HOURS OF THE INDEX PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 21413470 ↗
• InjuryFeb 18, 2025Failure to Cycle; Failure to Cycle

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). MULTIPLE NON-SHOCKWAVE BALLOONS WERE USED TO PRE-DILATE THE VESSEL. AFTER 70 IVL PULSES WERE DELIVERED AT A MAX OF 6 ATM, THE PULSING STOPPED AND A CATHETER ERROR: END OF LIFE (EOL) APPEARED. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF A SECOND CATHETER. TWO DES STENTS WERE PLACED IN THE LAD FOLLOWED BY POST-DILATATION WITH MULTIPLE NON-SHOCKWAVE BALLOON CATHETERS. THERE WAS NO PATIENT SEQUALAE REPORTED. THE PATIENT WAS DISCHARGED A DAY AFTER THE INDEX PROCEDURE. ONE DAY POST-OP, THE PATIENT EXPERIENCED A NON-Q-WAVE MYOCARDIAL INFARCTION (MI). THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED THE MI WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE MI WAS REPORTED TO OCCUR A DAY AFTER THE INDEX PROCEDURE. THE CEC NOTED LOSS OF A SIDE BRANCH AND NO NEW Q WAVES. THE PATIENT'S CREATINE KINASE-MB (CK-MB) LEVELS WERE GREATER THAN 5 TIMES THE UPPER LIMIT OF NORMAL (ULN), BUT LESS THAN 10 TIMES THE ULN. IT WAS DETERMINED THAT THE MI WAS POSS

  Patient problems: Myocardial Infarction

  MAUDE report 21403056 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. 100 PULSES WERE SUCCESSFULLY DELIVERED AT A MAX OF 6 ATM. THERE WAS NO IVL MALFUNCTION REPORTED. PRIOR TO AND DURING THE PROCEDURE, THE PATIENT DID NOT HAVE ANY CARDIAC ENZYMES. FORTY-EIGHT (48) HOURS AFTER THE PROCEDURE, THE PATIENT'S TROPONIN LEVELS BECAME ELEVATED TO 70 TIMES THE UPPER NORMAL LIMIT (ULN). THE TROPONIN LEVELS NORMALIZED WITHOUT INTERVENTION AND THE PATIENT WAS DISCHARGED. THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE (CEC) WHICH CONFIRMED A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WAS ATTRIBUTABLE TO THE TARGET VESSEL. FILM WAS REVIEWED AND SLOW FLOW IN THE SEPTAL BRANCH WAS OBSERVED. IT WAS DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction; Reduced Blood Flow

  MAUDE report 21337235 ↗
• MalfunctionNov 1, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO A TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERIES. THE CATHETER WAS INSERTED INTO THE VESSEL BUT WOULD NOT ADVANCE PAST THE MID LAD DUE TO ACUTE BEND AND CALCIFICATION. IVL WAS PERFORMED WITH MULTIPLE ATTEMPTS AT ADVANCING THROUGH THE HIGHLY CALCIFIED SEGMENT WITH MINIMAL MOVEMENT. SEVEN CYCLES WERE SUCCESSFULLY DELIVERED. THE PHYSICIAN THEN ADVANCED THE GUIDEZILLA GUIDE EXTENSION CATHETER OVER THE SHOCKWAVE BALLOON SHAFT WHILE MAKING MULTIPLE ATTEMPTS TO PULL IT BACK. AFTER SEVERAL ATTEMPTS OF REPOSITIONING THE CATHETER THE PHYSICIAN STATED THE SHAFT WAS NO LONGER CONNECTED TO THE BALLOON. THE SHAFT HAD THEN BROKEN AND WAS REMOVED FROM THE PATIENT, LEAVING THE DISTAL BALLOON AND A PORTION OF THE CATHETER LODGED IN THE LAD ARTERY AND HANGING OUT INTO THE AORTIC ARCH. THE WIRE POSITION IN THE VESSEL WAS LOST AND MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RECROSS THE LAD. THE DECISION WAS THEN MADE TO PERFORM CARDIOVASCULAR (CV) SURGERY. AN IMPELLA VENTRICULAR ASSIST DEVICE WAS INSERTED AND THEN THE PATIENT WAS SENT TO SURGERY FOR A BYPASS AND TO ATTEMPT REMOVAL OF THE REMAINING PORTION OF TH

  Patient problems: Foreign Body In Patient

  MAUDE report 20588874 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. ON JULY 12, 2024, A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT MID ANTERIOR DESCENDING (LAD) ARTERY. THE IVL CATHETER SUCCESSFULLY DELIVERED 60 PULSES AT 10 ATM. POST DILATION WAS PERFORMED, AND THREE (3) STENTS WERE SUCCESSFULLY PLACED. THERE WAS NO REPORT OF AN IVL DEVICE MALFUNCTION. MYOCARDIAL INFARCTION (MI) OCCURRED THE SAME DAY AS THE INDEX PROCEDURE. THE PATIENT COMPLAINED OF WORSENING HYPERTENSION, CHEST PAIN, BACK PAIN, MILD NAUSEA AND VOMITING. THE SYMPTOMS WERE TREATED WITH HYDRALAZINE, ZOFRAN AND MORPHINE INTRAVENOUSLY WITH FAVORABLE EFFECTS TO THE PATIENT. IN ADDITION, THE PATIENT WAS TREATED WITH ASPIRIN AND PRASUGREL. AN EKG WAS OBTAINED, AND THE PATIENT WAS RELEASED THE FOLLOWING DAY. THE CLINICAL SITE HAS DETERMINED THAT THE RELATIONSHIP OF MI TO THE STUDY AND PROCEDURE WAS POSSIBLE/DEFINITE.

  Patient problems: Myocardial Infarction

  MAUDE report 20539818 ↗
• DeathOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT RADIAL ACCESS WAS OBTAINED USING A 6FR SHEATH, THEN A GUIDEWIRE WAS PLACED IN THE LAD. A SAPPHIRE BALLOON WAS INFLATED TWICE AT 8 ATM IN THE MID-LAD, WITH A SUBSEQUENT INFLATION; HOWEVER, THE ATM IS UNKNOWN. THE C2+ WAS THEN POSITIONED IN THE LAD AND INFLATED TO 4 ATM AND 100 PULSES WERE DELIVERED. THIS WAS FOLLOWED BY THE PLACEMENT OF AN NC NEO TREK BALLOON, BUT THE ATM FOR THIS INFLATION IS UNKNOWN. FOLLOWING ANGIOGRAPHY, A DISSECTION WAS OBSERVED BOTH PROXIMALLY AND DISTALLY IN THE LAD; THE DISSECTION GRADE WAS NOT REPORTED. THE PATIENT EXPERIENCED RAPID HEMODYNAMIC DETERIORATION AND CODED ON THE TABLE. THE STAFF INDICATED THAT THEY DO NOT BELIEVE THE DISSECTION WAS A RESULT OF THE C2+ DEVICE. NO STENT WAS PLACED DURING THE PROCEDURE.

  Patient problems: Hemodynamic instability; Vascular Dissection

  MAUDE report 20472813 ↗
• DeathSep 24, 2024Difficult to Advance; Difficult to Advance

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PATIENT UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND EXPERIENCED DIFFICULTY CROSSING THE LESION. IT WAS REPORTED THAT AFTER INITIAL PREDILATION, THE IMPELLA DEVICE WAS IN PLACE BUT COULD NOT PASS THE LESION. ATTEMPTS TO USE THE IVL CATHETER WERE UNSUCCESSFUL AS THE DEVICE COULD NOT BE ADVANCED. THE REPRESENTATIVE REPORTED NO RESISTANCE WAS ENCOUNTERED WHEN TRACKING THE CATHETER OVER THE WIRE OR THROUGH THE SHEATH, BUT THE DIFFICULTY WAS OBSERVED AT THE LESION SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON. DESPITE COMPLETING THE INTENDED PROCEDURE, THE PATIENT, WHO REMAINED HOSPITALIZED, LATER EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20297749 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE PATIENT'S CARDIAC ARREST, REVASCULARIZATION, AND STENT THROMBOSIS. IT WAS REPORTED THAT CARDIAC ARREST OCCURRED POST INDEX PROCEDURE. THE CEC DETERMINED THAT THE CARDIAC ARREST IS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD RECURRING ISCHEMIA POST INDEX PROCEDURE AND THE CATH REVEALED THROMBUS AT THE STENT SITE REQUIRING REPEAT INTERVENTION (PCI). THERE WERE OBJECTIVE SIGNS OF ISCHEMIA AT REST (ECG CHANGES) OR DURING THE EXERCISE TEST (OR EQUIVALENT), PRESUMABLY RELATED TO THE TARGET VESSEL. THE CEC DETERMINED THAT THE STENT THROMBOSIS AND REVASCULARIZATION ARE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Cardiac Arrest; Chest Pain; Ischemia; Myocardial Infarction; Respiratory Failure; Thrombosis/Thrombus

  MAUDE report 20218531 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX). THE IVL CATHETER SUCCESSFULLY DELIVERED 120 PULSES. THERE WAS NO REPORT OF AN IVL DEVICE MALFUNCTION. THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE PATIENT'S MYOCARDIAL INFARCTION. THE CEC INDICATED THAT FILM WAS REVIEWED AND LOSS OF SIDE BRANCH WAS OBSERVED WITH CREATINE KINASE-MB (CK-MB) LEVELS GREATER THAN 10X THE UPPER NORMAL LIMIT (ULN) WITHIN 48 HOURS OF THE PROCEDURE. CEC HAS DETERMINED THAT MYOCARDIAL INFARCTION IS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 20214553 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE CORONARY C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). 90 PULSES WERE DELIVERED AT PRESSURES OF 4 TO 6 ATM. A 2.5X48MM SYNERGY STENT WAS PLACED AND POST-DILATED WITH A 3.0 NON-COMPLIANT (NC) BALLOON. THE FINAL IMAGING SHOWED SUCCESSFUL RESULTS. THERE WAS NO REPORTED IVL MALFUNCTION. 30 MINUTES POST PROCEDURE, THE PATIENT WAS COMPLAINING OF SEVERE CHEST PAIN. MEDS WERE GIVEN TO HELP WITH THE PAIN AND VITALS APPEARED GOOD, BUT THE PAIN INCREASED TO 10/10. THE PHYSICIAN CHOSE TO PROCEED WITH RIGHT GROIN ACCESS TO PERFORM ANOTHER ANGIOGRAM. LUCENCY WAS OBSERVED IN DISTAL LEFT MAIN (LM) AT THE LAD/CIRCUMFLEX (CX)BIFURCATION AND A RE-INTERVENTION WAS INITIATED. BOTH CX AND LAD WERE WIRED USING A 3.0X15MM BALLOON TO PRE-DILATE THE LESION ON THE LAD WIRE AT DISTAL LM AND THEN THE BALLOON WAS RETURNED TO PRE-DILATE LM-PROXIMAL CX. A 3.0X20MM SYNERGY STENT WAS PLACED IN THE PROXIMAL CX AND POST DILATED WITH A 3.0X20 NC BALLOON. A 3.5X20MM SYNERGY STENT WAS THEN PLACED FROM LM TO PROXIMAL LAD AND POST DILATED LM WITH A 4.5X15 NC BALLOON. THE PATIENT'S BLOOD PRESSURE DROPPED NECESSITATING THE USE O

  Patient problems: Chest Pain; Vascular Dissection

  MAUDE report 19933885 ↗
• DeathJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO SHOCKWAVE VIA THE POST MARKET EMPOWER CAD CLINICAL STUDY. A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER WAS USED TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY. THE IVL CATHETER SUCCESSFULLY DELIVERED 50 PULSES AND THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT PRESENTED 2 WEEKS POST-OP WITH A STENT THROMBOSIS AND SUBSEQUENTLY EXPIRED 15 DAYS AFTER THE INDEX PROCEDURE. THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE STENT THROMBOSIS AND DEATH. THE CEC HAS DETERMINED THAT THE STENT THROMBOSIS AND DEATH ARE POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLE TO THE PROCEDURE. THE CEC INDICATED THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE PROBABLE STENT THROMBOSIS AND THAT THE CARDIAC DEATH OCCURRED WITHIN 2 WEEKS OF THE INDEX PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19784285 ↗
• InjuryJul 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER 50 PULSES WERE DELIVERED, THE IVL BALLOON RUPTURED AND PERFORATED THE RCA. THE PHYSICIAN TRIED TO DELIVER A PAPYRUS COVERED STENT BUT WAS UNSUCCESSFUL. A 2.25 X 15 BALLOON WAS USED TO OCCLUDE THE PERFORATION FOR 60 SECONDS, AND AGAIN ATTEMPTED TO DELIVER A COVERED STENT WITH A DIFFERENT GUIDE CATHETER WHICH WAS UNSUCCESSFUL. A DRUG ELUDING STENT (DES) WAS THEN DELIVERED PROXIMAL TO THE PERFORATION, AND THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE WITH A SMALL RESIDUAL PERFORATION IN THE MID RCA. THE PATIENT WAS TRANSFERRED TO THE ICU, AND THEN TRANSFERRED TO ANOTHER HOSPITAL. A BALLOON PUMP WAS SURGICALLY INSERTED, AND THE PATIENT WAS MONITORED. CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 19726577 ↗