Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter C2PIVL3012Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00195451000010), received between Mar 12, 2024 and Aug 27, 2026 — classified as 9 deaths, 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Material Split, Cut or Torn

  Patient problems: Low Blood Pressure/ Hypotension; Low Cardiac Output

  MAUDE report 50465505 ↗
• InjuryMay 22, 2026Difficult to Advance

  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 2.5MM SHOCKWAVE C2+ CORONARY IVL BALLOON (MDR# 3015053858-2026-00048) DESPITE MULTIPLE PRE-DILATATION ATTEMPTS WITH 2.5MM AND 3.0MM 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 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 IN

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 25262411 ↗
• MalfunctionJan 14, 2026Difficult to Remove

  IT WAS REPORTED THAT A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE CORONARY ARTERY. THE LESION WAS HEAVILY CALCIFIED AND REQUIRED A 6 FR TELESCOPE GUIDE-EXTENSION CATHETER TO SUPPORT ADVANCEMENT OF A C2+ IVL CATHETER BALLOON. DURING AN ATTEMPT TO TREAT A DIAGONAL BRANCH, WHILE INSERTING THE IVL DEVICE INTO THE TELESCOPE GUIDE-EXTENSION CATHETER, IT BECAME STUCK. THE PHYSICIAN DID NOT PULSE THE C2+ IVL BALLOON SINCE THEY REALIZED IT WAS STUCK; NO PULSES WERE DELIVERED AND THE DEVICE WAS NEVER INFLATED. THE TELESCOPE GUIDE-EXTENSION CATHETER WAS ALSO UNABLE TO BE REMOVED FROM THE PATIENT. BOTH 6 FR TELESCOPE GUIDE-EXTENSION CATHETER AND C2+ IVL BALLOON BECAME STUCK IN THE DIAGONAL BRANCH DESPITE MULTIPLE RETRIEVAL ATTEMPTS. THE PHYSICIAN OBTAINED CONTRALATERAL ACCESS AND A SECOND GUIDE CATHETER AND INTERVENTIONAL WIRE WERE INTRODUCED IN PARALLEL BESIDE THE EXISTING GUIDE CATHETER. THE PHYSICIAN WAS ABLE TO CROSS THE LESION AND INFLATE A SMALL BALLOON TO DISLODGE THE 6 FR TELESCOPE GUIDE-EXTENSION AND C2+ IVL BALLOON. THE RADIO-OPAQUE TIP OF THE 6 FR TELESCOPE GUIDE-EXTENSION CATHETER REMAINED LODGED IN THE DIAGO

  Patient problems: Foreign Body In Patient

  MAUDE report 24064476 ↗
• DeathDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD) OF A PATIENT WITH COMPLEX CORONARY ARTERY DISEASE (LEFT MAIN LESION, HEAVILY CALCIFIED LAD LESIONS, AND CTOS OF THE CIRCUMFLEX AND RCA) WHO HAD PREVIOUSLY UNDERGONE OUTSIDE-HOSPITAL CATHETERIZATION WITH PLACEMENT OF A LEFT MAIN DES AFTER BEING DEEMED A POOR SURGICAL BYPASS CANDIDATE DUE TO PERICARDIAL CALCIFICATION AND SUBOPTIMAL GRAFT TARGETS. HE WAS READMITTED WITH RECURRENT ISCHEMIC SYMPTOMS AND TAKEN TO THE CARDIAC CATHETERIZATION LAB VIA RIGHT FEMORAL ACCESS WITHOUT DIFFICULTY. ANGIOGRAPHY WAS PERFORMED USING A VODA 4 GUIDE AND A RUNTHROUGH WIRE TO THE LAD; PRE-DILATION OF THE LAD WAS PERFORMED WITH A EUPHORA BALLOON, AND IVUS COULD NOT CROSS THE LAD BUT WAS PERFORMED IN THE LEFT MAIN, DEMONSTRATING A MINIMAL LUMEN AREA OF ROUGHLY 8 MM AND AREAS OF STENT MAL-APPOSITION. THREE RESOLUTE ONYX DRUG ELUTING STENTS (DES) WERE DEPLOYED TO THE DISTAL AND MID LAD, AND THE PREVIOUSLY PLACED 4.00×8 MM LEFT MAIN STENT WAS POST-DILATED PER IVUS GUIDANCE WITH A NONCOMPLIANT EUPHORA BALLOON UNTIL THE OPERATOR JUDGED EXPANSION ADEQUATE. PERSISTENT UNDER

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Myocardial Infarction

  MAUDE report 23918544 ↗
• DeathDec 22, 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 DENSELY NODULAR LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5 EMERGE BALLOON (THREE INFLATIONS AT 14 ATM), THE 2.5 EMERGE WAS THEN REINSERTED FOR THREE ADDITIONAL INFLATIONS AT 20 ATM, THE LEFT CIRCUMFLEX (LCX) WAS BALLOONED, AND A 2.5 EMERGE WAS USED FOR TWO INFLATIONS AT 14 ATM. AN ATTEMPT TO CROSS THE LESION WITH A 3.0 ONYX STENT WAS UNSUCCESSFUL AND A 3.0 EMERGE BALLOON WAS SUBSEQUENTLY USED AND BURST ON THE SECOND INFLATION AT 20 ATM. A 3.0 IVL BALLOON WAS THEN DEPLOYED AND DURING THE FIRST CYCLE (10 PULSES AT 4ATM) A LOSS OF PRESSURE WAS OBSERVED. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED DURING DEVICE REMOVAL AND INSPECTION REVEALED THE FRONT HALF OF THE BALLOON MATERIAL WAS MISSING AND SUSPECTED TO HAVE BEEN LEFT IN THE ARTERY. THE PATIENT WAS INITIALLY STABLE BUT BECAME HEMODYNAMICALLY UNSTABLE DURING FURTHER LAD TREATMENT, PROMPTING ESCALATION TO IMPELLA SUPPORT FOR STABILIZATION. THE PATIENT WAS MONITORED OVERNIGHT AND SUBSEQUENTLY EXPIRED. THE CAUSE OF DEATH REMAINS UNKNOWN.

  Patient problems: Foreign Body In Patient; Hemodynamic instability

  MAUDE report 23873615 ↗
• InjuryNov 18, 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+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE IVL CATHETER DELIVERED 10 PULSES AT 6 MAX ATMOSPHERIC PRESSURES (ATM). MULTIPLE NON-COMPLIANT (NC) BALLOONS WERE USED FOR PRE AND POST DILATATION, AND A STENT WAS SUCCESSFULLY DELIVERED WITH NO RESIDUAL STENOSIS WITHIN THE TARGET LESION. THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE AROUND THE 30-DAY FOLLOW-UP TIMEPOINT. EIGHTEEN (18) MONTHS POST INDEX PROCEDURE, A PLANNED CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE WAS PERFORMED AFTER PREOPERATIVE HEMODIALYSIS. AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE ICU FOR RECOVERY IN STABLE CONDITION. THE EVENT WAS CLASSIFIED AS SEVERE AND MET A MAJOR ADVERSE CARDIAC EVENT (MACE). THE PATIENT WAS DISCHARGED ON (B)(6) 2025, WITH ONE DRAIN IN PLACE. THERE WAS NO REPORT OF AN IVL DEVICE MALFUNCTION.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23578769 ↗
• InjuryNov 6, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED DURING A PROCEDURE TO TREAT THE PATIENT'S CORONARY ARTERY. PRE-DILATION WAS PERFORMED WITH A 2.0 SEMI-COMPLIANT BALLOON, FOLLOWED BY THE FIRST SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER (B)(6). ACCESS WAS GAINED VIA THE RADIAL ARTERY. NO RESISTANCE WAS ENCOUNTERED WHILE TRACKING THE CATHETER OVER THE GUIDEWIRE OR THROUGH THE SHEATH. THE BALLOON PRESSURE WAS INCREASED TO 2 ATM, BUT THEN A LOSS OF PRESSURE WAS OBSERVED. BLOOD WAS NOTED IN THE INDEFLATOR, INDICATING THAT THE BALLOON HAD RUPTURED. THE SHOCKWAVE BALLOON WAS REMOVED INTACT. A SECOND SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER (B)(6) WAS OPENED. ALTHOUGH IT WAS ADEQUATELY PREPPED AND DELIVERED 10 PULSES, THIS CATHETER WOULD NOT ADVANCE TO THE LESION. AN ANGIOGRAM WAS PERFORMED REVEALING A DISSECTION. THE PHYSICIAN THEN PROCEEDED WITH SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS WHICH WERE ABLE TO CROSS THE LESION. DIFFICULTY OCCURRED WHILE ADVANCING TO THE LESION, WITH NO KINK OR DEVICE BREAKAGE OBSERVED. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS AND CALCIFIED ANATOMY. THE PATIENT WAS

  Patient problems: Vascular Dissection

  MAUDE report 23493340 ↗
• InjuryNov 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED DURING A PROCEDURE TO TREAT THE PATIENT'S CORONARY ARTERY. PRE-DILATION WAS PERFORMED WITH A 2.0 SEMI-COMPLIANT BALLOON, FOLLOWED BY THE FIRST SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER (B)(6). ACCESS WAS GAINED VIA THE RADIAL ARTERY. NO RESISTANCE WAS ENCOUNTERED WHILE TRACKING THE CATHETER OVER THE GUIDEWIRE OR THROUGH THE SHEATH. THE BALLOON PRESSURE WAS INCREASED TO 2 ATM, BUT THEN A LOSS OF PRESSURE WAS OBSERVED. BLOOD WAS NOTED IN THE INDEFLATOR, INDICATING THAT THE BALLOON HAD RUPTURED. THE SHOCKWAVE BALLOON WAS REMOVED INTACT. A SECOND SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER (B)(6) WAS OPENED. ALTHOUGH IT WAS ADEQUATELY PREPPED AND DELIVERED 10 PULSES, THIS CATHETER WOULD NOT ADVANCE TO THE LESION. AN ANGIOGRAM WAS PERFORMED REVEALING A DISSECTION. THE PHYSICIAN THEN PROCEEDED WITH SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS WHICH WERE ABLE TO CROSS THE LESION. DIFFICULTY OCCURRED WHILE ADVANCING TO THE LESION, WITH NO KINK OR DEVICE BREAKAGE OBSERVED. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS AND CALCIFIED ANATOMY. THE PATIENT WAS

  Patient problems: Vascular Dissection

  MAUDE report 23493332 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT TREATMENT USING SHOCKWAVE C2+ IVL CORONARY CATHETER SYSTEM TO TREAT CORONARY ARTERY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISSECTION DURING THE PROCEDURE. DURING SURGICAL TURNDOWN, THE IVL CATHETER DELIVERED TWO CYCLES DISTALLY WHEN THE PATIENT DECOMPENSATED. THE IVL BALLOON WAS MOVED PROXIMALLY AND AN ADDITIONAL TWO CYCLES (20 PULSES) WERE DELIVERED. BETWEEN EACH CYCLE, THE IVL BALLOON WAS PULLED BACK TO ALLOW THE PATIENT TO RECOVER. AFTER THE TWO PROXIMAL CYCLES, THE PATIENT EXPERIENCED CHEST PAIN, AND THE PATIENT'S HEART RATE SLOWED INTO THE 30S. A STENT WAS PLACED FROM DISTAL TO PROXIMAL TO TREAT THE DISSECTION, AND INTEGRILIN ADMINISTERED. THE PATIENT'S HEART RHYTHM NORMALIZED TO THE 70S WITHIN A FEW MINUTES. THE EVENT RESULTED IN EXTRA TIME IN THE HOSPITAL, AND THERE WERE NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Bradycardia; Chest Pain; Vascular Dissection

  MAUDE report 23080824 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT PATIENT IS A 66 YEAR-OLD FEMALE, "SUBJECT (B)(6)", ENROLLED IN THE STUDY ENTITLED, "SHOCKWAVE LITHOPLASTY COMPARED TO CUTTING BALLOON TREATMENT IN CALCIFIED CORONARY DISEASE - A RANDOMIZED CONTROLLED TRIAL (SHORT-CUT)". ON (B)(6) 2025, THE SUBJECT WHO PRESENTED WITH STABLE ANGINA, UNDERWENT PERCUTANEOUS CORONARY INTERVENTION USING SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER IN THE RIGHT CORONARY ARTERY (RCA). PRE-PROCEDURE THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW WAS II WITH 99% STENOSIS. POST PROCEDURE TIMI FLOW WAS III WITH 0% STENOSIS. THE OPERATIVE REPORT NOTED THAT DURING THE PLACEMENT OF A 3.0 X 48 SYNERGY STENT, THERE WAS AN ELLIS CLASS III PERFORATION OBSERVED. THIS WAS STABILIZED BY INFLATING THE STENT BALLOON TO 4 ATM WHILE A LEFT FEMORAL ARTERY ACCESS WAS OBTAINED. A SECOND GUIDE WAS ENGAGED IN THE RCA USING A "PING PONG" TECHNIQUE. A 3.5 X 26 PAPYRUS AND A 2.5 X 20 PAPYRUS WERE DEPLOYED IN AN OVERLAPPING FASHION IN THE OSTIAL TO MID RCA WHICH SEALED THE PERFORATION. SUCCESSFUL PERICARDIOCENTESIS WAS DONE WITH A DRAINAGE OF 400ML OF SANGUINEOUS/BLOODY FLUID. THE DRAIN REMAINED IN THE SUBJECT, AND THE SUBJECT WAS THEN TRANSFERRED TO

  Patient problems: Chest Pain; Perforation of Vessels; Pericardial Effusion; Pericarditis

  MAUDE report 22790290 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT PATIENT IS AN 80-YEAR-OLD FEMALE, (B)(6), ENROLLED IN THE STUDY ENTITLED, "SHOCKWAVE LITHOPLASTY COMPARED TO CUTTING BALLOON TREATMENT IN CALCIFIED CORONARY DISEASE - A RANDOMIZED CONTROLLED TRIAL (SHORT-CUT)". ON (B)(6) 2025, THE SUBJECT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION USING SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER IN THE PROXIMAL LAD (LEFT ANTERIOR DESCENDING ARTERY). THE TREATMENT FOR THE TARGET LESION INVOLVED SEVERAL KEY STEPS: ROTA ATHERECTOMY WAS PERFORMED IN THE PROXIMAL LAD, FOLLOWED BY POST-ATHERECTOMY INTRAVASCULAR ULTRASOUND (IVUS). A 3.5 X 20 MM EMERGE BALLOON WAS THEN INFLATED, FOLLOWED BY THE TREATMENT WITH INTRAVASCULAR LITHOTRIPSY (IVL) AND ANOTHER POST-IVL IVUS. FURTHER BALLOON INFLATIONS INCLUDED A 3.5 X 20 MM NON-COMPLIANT (NC) EMERGE, AND BOTH A 3.5 X 24 MM SYNERGY STENT AND A 3.5 X 24 MM MEGATRON STENT WERE INFLATED AND PLACED. ADDITIONAL INFLATIONS INVOLVED A 3.5 X 15 MM NC EMERGE AND A 2.0 X 15 MM NC EMERGE, CONCLUDING WITH A FINAL IVUS. THE SUBJECT EXPERIENCED POST-PROCEDURAL HYPOTENSION REFRACTORY TO FLUIDS AND NEW PERICARDIAL EFFUSION CONCERNING FOR TAMPONADE. AN ECHOCARDIOGRAM REVEALED A NEW ONSET PERICARDIA

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion

  MAUDE report 22548051 ↗
• DeathJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PATIENT WITH A KNOWN POOR EJECTION FRACTION (EF) AND CARDIAC CONDITION. APPROXIMATELY, THIRTY (30) CYCLES WERE DELIVERED. DURING THE PROCEDURE, THE PATIENT EXPERIENCED AN UNSPECIFIED EVENT THAT REQUIRED CHEST COMPRESSION. ONCE THE PATIENT WAS STABILIZED, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY STENT PLACEMENT. THE FOLLOWING DAY, THE PHYSICIAN REPORTED THAT THE PATIENT HAD PASSED AWAY POST-PROCEDURE. THE PHYSICIAN INDICATED MULTIPLE TIMES THAT THE USE OF THE IVL DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH AND ATTRIBUTED THE OUTCOME TO PRE-EXISTING MEDICAL CONDITIONS.

  Patient problems: Insufficient Information

  MAUDE report 22546954 ↗
• DeathMar 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX). THE PROCEDURE FACED INITIAL ACCESSIBILITY CHALLENGES, REQUIRING SMALL BALLOONS AND SIGNIFICANT BALLOONING WITH A NON-COMPLIANT (NC) BALLOON. INTRAVASCULAR ULTRASOUND (IVUS) WAS DIFFICULT BUT EVENTUALLY SUCCESSFUL BEFORE IVL. DURING THE PROCEDURE, 50 IVL PULSES WERE DELIVERED AT 4 ATM BEFORE THE BALLOON RUPTURED. IT WAS REPORTED THAT THE TECH MAY HAVE INJECTED AIR FOLLOWING THE RUPTURE. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (V FIB) MULTIPLE TIMES, WAS IMMEDIATELY SHOCKED, A CODE WAS CALLED, AND THE PATIENT WAS INTUBATED. EMERGENCY MEDICATIONS WERE ADMINISTERED. THE PATIENT HAD A RETURN OF SPONTANEOUS CIRCULATION (ROSC) BUT CONTINUED TO GO BACK INTO V FIB OVER THE NEXT 45 MINUTES. THE PATIENT PASSED AWAY FOLLOWING THE CODE, APPROXIMATELY 45 MINUTES LATER. THE LAST IMAGE SHOWED THE VESSEL WAS OPEN, BUT IMAGING STOPPED WHEN V FIB OCCURRED, AND THE CODE BEGAN. THE PHYSICIAN NOTED THE POSSIBILITY OF AIR INJECTION POST-RUPTURE BUT DID NOT DIRECTLY ATTRIBUTE THE ISSUES TO THE IVL DEVICE.

  Patient problems: Arrhythmia; Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 21590192 ↗
• InjuryMar 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  TWO SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A NODULAR DE NOVO LESION IN THE CORONARY ARTERY VIA THE FEMORAL ARTERY. IT WAS REPORTED THAT THE FIRST BALLOON RUPTURED AFTER 40 PULSES. A SECOND IVL BALLOON WAS USED, WHICH ALSO RUPTURED AFTER 60 PULSES (MFR#3015053838-2025-00047). IVUS IMAGING REVEALED A DISSECTION IN THE VESSEL. THE PHYSICIAN INSERTED A BALLOON PUMP TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS SOME REFLOW BUT NO DISSECTION, AND THE PATIENT EXPERIENCED CHEST PAIN, LEADING TO THE INSERTION OF A BALLOON PUMP. THE DISTAL WIRE WAS SUBINTIMAL, AND REFLOW WAS CORRECTED WITH A BALLOON, STENT, AND ANGIO SCULPT. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT NO PRE-DILATION WAS PERFORMED, AND A XIENCE DRUG-ELUTING STENT (DES) WAS IMPLANTED POST-IVL. SHOCKWAVE MEDICAL IS ATTEMPTING TO GATHER ADDITIONAL INFORMATION RELATED TO THIS EVENT AND PATIENT CURRENT STATUS.

  Patient problems: Chest Pain; Reduced Blood Flow; Vascular Dissection

  MAUDE report 21540569 ↗
• DeathMar 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A DENOVO LESION WITH NODULAR CALCIUM IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER 40 PULSES WERE DELIVERED, THE BALLOON LOST PRESSURE. POST IVL, A CUTTING/SCORING BALLOON WAS USED FOLLOWED BY THE PLACEMENT OF A DRUG ELUTING STENT (DES). THE PROCEDURE WAS FINISHED SUCCESSFULLY, AND THE DRUG ELUTING STENTS WERE IMPLANTED AS INTENDED. THE PATIENT, WHO HAD TRIPLE VESSEL DISEASE AND DIABETES, PASSED AWAY POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT MAY HAVE LOST SEPTAL FLOW, WHICH WAS SUPPORTING THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) BEFORE THE PATIENT EXPIRED. THE PATIENT DID NOT PASS AWAY IMMEDIATELY AFTER THE IVL TREATMENT AND SHOWED ONLY SLIGHT CHEST PAIN WHEN THE SEPTAL FLOW DECREASED. THE PATIENT EXPIRED DURING RECOVERY. THE ACCESS SITE WAS FEMORAL AND THE INTERVAL BETWEEN THE IVL TREATMENT AND THE PATIENT'S DEATH IS UNKNOWN. THE CAUSE OF THE DEATH IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE CO-MORBIDITIES AND THE DEATH WAS NOT RELATED TO THE PCI PROCEDURE.

  Patient problems: Chest Pain; Reduced Blood Flow

  MAUDE report 21518564 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE MID-LEFT ANTERIOR DESCENDING (MLAD) ARTERIES WHICH DEMONSTRATED AN FRACTIONAL FLOW RESERVE (FFR) OF 0.76. THE PATIENT PRESENTED WITH CHEST PAIN. INITIAL ANGIOGRAMS SHOWED MILD DISEASE IN THE RIGHT AND LEFT CORONARY ARTERIES. THE TARGET LESION WAS PRE-DILATED WITH A 2.50X15MM NC EUPHORIA BALLOON AT 14 ATM. A 3.00X12MM IVL CATHETER WAS USED, DELIVERING 80 PULSES AT 4 ATM. THE LESION YIELDED AFTER THE FINAL PULSES, BUT A LARGE PERFORATION IN THE MLAD WAS NOTED. THE IVL BALLOON WAS TEMPORARILY INFLATED PROXIMAL TO THE PERFORATION TO SLOW THE EXTRAVASATION OF BLOOD INTO THE PERICARDIAL SPACE. TWO SYNERGY DRUG ELUTING STENTS WERE PLACED TO SEAL OFF THE PERFORATION BUT SUBSEQUENT ANGIOGRAM SHOWED IT WAS STILL OCCURRING, SO THE PHYSICIAN PLACED TWO PAPYRUS COVERED STENTS TO FURTHER SEAL IT OFF. POST-STENT DILATATION WAS COMPLETED, FOLLOWED BY EMERGENT ECHOCARDIOGRAM AND PLACEMENT OF A PERI-CARDIOCENTESIS DRAIN. THE PATIENT REMAINED STABLE AND LEFT THE CATHETERIZATION LAB SHORTLY AFTERWARDS. APPROXIMATELY ONE HOUR LATER, THE PATIENT EXPERIENCED ADDITIONAL CHEST PAIN AND WAS RETURNED TO THE CA

  Patient problems: Chest Pain; Perforation of Vessels

  MAUDE report 21513229 ↗
• 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 RIGHT CORONARY ARTERY (RCA). MULTIPLE NON-SHOCKWAVE BALLOONS WERE USED TO PRE-DILATE THE VESSEL. 60 IVL PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATM. DRUG ELUTING STENTS (DES) WERE PLACED IN THE RCA FOLLOWED BY POST-DILATATION WITH MULTIPLE NON-SHOCKWAVE BALLOON CATHETERS. THERE WAS NO PATIENT SEQUALAE REPORTED. ADDITIONALLY, THERE WAS NO IVL MALFUNCTION REPORTED. THE PATIENT WAS DISCHARGED THE SAME DAY AS 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 A NON Q-WAVE MI ATTRIBUTABLE TO THE TARGET VESSEL. THE MI WAS REPORTED TO OCCUR THE SAME DAY AS THE INDEX PROCEDURE. THE CEC NOTED THAT THE TROPONIN LEVELS WERE GREATER THAN 70 X UPPER LIMIT OF NORMAL (ULN) WITHIN 48 HOURS OF THE INDEX PROCEDURE. THEY DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 21471074 ↗
• InjuryFeb 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT DURING THE PROCEDURE, A 3.0 SHOCKWAVE BALLOON EXPERIENCED A LOSS OF PRESSURE, AND A THROMBUS WAS OBSERVED POST-ANGIOGRAPHY DISTAL TO THE ORIGINAL LESION. THE PATIENT EXPERIENCED CHEST DISCOMFORT AND ST ELEVATION. A THROMBECTOMY WAS PERFORMED TO REMOVE THE CLOT AND THEN ANOTHER 3.5 SHOCKWAVE BALLOON WAS USED TO DELIVER 80 ADDITIONAL PULSES TO COMPLETE THE CASE. THE RCA WAS STENTED, AND THE PATIENT WAS OBSERVED OVERNIGHT AND REMAINED STABLE WITH A GOOD OUTCOME. AFTER REVIEWING THE FILMS, THE PHYSICIAN NOTED THAT THE LESION HAD MIXED MORPHOLOGY, AND THE CLOT DID NOT APPEAR TO BE CAUSED BY THE BALLOON'S LOSS OF PRESSURE.

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 21465111 ↗
• 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 MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). A NON-COMPLIANT BALLOON WAS USED TO PRE-DILATE THE VESSEL BEFORE THE IVL CATHETER WAS USED TO SUCCESSFULLY DELIVER 120 PULSES AT MAX OF 4ATM. A DRUG ELUTING STENT (DES) WAS PLACED AND ANOTHER NON-COMPLIANT BALLOON WAS USED FOR POST-STENT DILATION TO COMPLETE THE PROCEDURE. DURING THE PROCEDURE, A TYPE A DISSECTION WAS NOTED IN THE LAD AND FOLLOWING STENT DEPLOYMENT, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND WAS SHOCKED TWICE. THESE EVENTS WERE REPORTED TO BE NOT RELATED TO THE IVL CATHETER. THERE WAS NO OTHER 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 PERIPROCEDURAL MI WAS ATTRIBUTABLE TO THE TARGET VESSEL. THE CEC NOTED ELEVATED TROPONIN LEVELS WITHIN 48 HOURS OF THE PROCEDURE AND DIAGONAL SIDE BRANCH OCCLUSION WITH NO NEW Q WAVES. IT WAS

  Patient problems: Myocardial Infarction; Vascular Dissection; Ventricular Fibrillation

  MAUDE report 21417439 ↗
• 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 MID LEFT ANTERIOR DESCENDING ARTERY. THERE WERE 100 PULSES SUCCESSFULLY DELIVERED AT 5 ATM. THREE STENTS WERE SUCCESSFULLY PLACED. THERE WAS NO IVL MALFUNCTION REPORTED. A MYOCARDIAL INFARCTION (MI) OCCURRED ONE DAY AFTER THE INDEX PROCEDURE AND PRIOR TO DISCHARGE. THE PATIENT WAS ADMINISTERED HEPARIN INTRAVENOUSLY WITH POSITIVE EFFECTS. TROPONIN LEVELS NORMALIZED WITHOUT ADDITIONAL INTERVENTION, AND THE PATIENT WAS DISCHARGED ONE DAY LATER. 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. IT WAS DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 21415053 ↗
• InjuryFeb 5, 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. 120 PULSES WERE SUCCESSFULLY DELIVERED AT 4 ATM. THERE WAS NO IVL MALFUNCTION REPORTED. THIS EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE MYOCARDIAL INFARCTION (MI). THE CEC DETERMINED THAT THE MI WAS A NON Q-WAVE MI ATTRIBUTABLE TO THE TARGET VESSEL. THEY DETERMINED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE SEPTAL WAS CLOSED AND THERE WAS HEART BLOCK, BUT NO Q WAVE.

  Patient problems: Myocardial Infarction

  MAUDE report 21318442 ↗
• InjuryFeb 3, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; 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 RIGHT CORONARY ARTERY. 70 PULSES WERE SUCCESSFULLY DELIVERED AT 10 ATM, ABOVE THE INDICATED PRESSURE OF 4 ATM FOR IVL TREATMENT PER THE DEVICE INSTRUCTIONS FOR USE. THERE WAS NO IVL MALFUNCTION REPORTED. AFTER THE PROCEDURE, THE PATIENT REPORTED CHEST PAIN. POST-PROCEDURE LABS ALSO NOTED ELEVATED TROPONIN LEVELS AND NO SIGNIFICANT EKG CHANGES. THE CLINICAL SITE DETERMINED THAT THE MYOCARDIAL INFARCTION (MI) WAS NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE PI EVALUATION NOTED CONCERN FOR POST PCI NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) FROM THE DISTAL EMBOLIZATION OF THE THROMBUS. THE PATIENT STARTED ON HEPARIN GGT. THE TELEMETRY OVERNIGHT REPORT NOTED EPISODES OF PREMATURE VENTRICULAR CONTRACTIONS (PVCS) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). A DAY AFTER THE INDEX PROCEDURE, THE PATIENT RATED THE CHEST PAIN A 1 OUT OF 10. TROPONIN LEVELS PEAKED AND HEPARIN WAS DISCONTINUED. THE NEXT DAY, PRIOR TO DISCHARGE, THE PATIENT CONFIRMED NO CHEST PAIN OR

  Patient problems: Arrhythmia; Chest Pain; Myocardial Infarction; Thromboembolism

  MAUDE report 21300300 ↗
• InjuryJan 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THIS REPORT IS FOR THE FIRST CATHETER (REFER TO MDR# 3015053858-2025-00004 FOR THE SECOND CATHETER). THE FIRST IVL BALLOON LOST PRESSURE ON THE THIRD PULSE OF THE FIRST CYCLE. AIR WAS INTRODUCED INTO THE VESSEL, ABRUPTLY CLOSING IT. ATROPINE AND HIGH FLOW OXYGEN WERE USED TO TREAT AND HELP THE PATIENT RECOVER FROM SEVERE BRADYCARDIA. THE PATIENT EXPERIENCED SIGNIFICANT ST DEPRESSIONS PRIOR TO THE BRADYCARDIA. ROTA WAS THEN USED TO OPEN THE VESSEL. A NEW IVL BALLOON WAS PULLED AND WOULD NOT CROSS THE LESION. AFTER BALLOONING, A STENT WAS PLACED. THE PATIENT WAS ORIGINALLY SCHEDULED FOR OUTPATIENT AND WAS ADMITTED FOR OBSERVATION POST EVENT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Arrhythmia; Bradycardia; Reduced Blood Flow

  MAUDE report 21071302 ↗
• InjuryOct 24, 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 TWO LESIONS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. LESION ONE WAS TREATED AND THE IVL CATHETER DELIVERED 30 PULSES AT 6 ATMOSPHERIC PRESSURES (ATM). ONE STENT WAS SUCCESSFULLY PLACED. LESION TWO WAS TREATED WITH 40 PULSES AT 6 ATMOSPHERIC PRESSURES (ATM). TWO STENTS WERE SUCCESSFULLY DELIVERED. MYOCARDIAL INFARCTION (MI) OCCURRED ALONG WITH CHEST PAIN ON (B)(6) 2024, ONE DAY AFTER THE IVL TREATMENT, PRIOR TO DISCHARGE. A REVIEW OF THE ANGIOGRAM REVEALED A SIDE BRANCH LOSS DURING PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT WAS TREATED WITH TICAGRELOR AND ASPIRIN. AFTER STABILIZATION, AN EKG (ELECTROCARDIOGRAM) WAS PERFORMED, SHOWING NO ABNORMALITIES AND STABLE VITALS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, (B)(6) 2024. THE CLINICAL SITE HAS DETERMINED THAT THE RELATIONSHIP OF THE MI AND CHEST PAIN TO BOTH THE STUDY AND PROCEDURE WAS PROBABLE/DEFINITE.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 20525652 ↗
• InjurySep 27, 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 (B)(6) 2024, A SHOCKWAVE C2+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A PATIENT UNDERGOING A LEFT HEART CATHETERIZATION (LHC) WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE MID LEFT DESCENDING ARTERY (LAD). IT WAS REPORTED THAT A SPIRAL DISSECTION AND OCCLUSION OCCURRED IN THE MID LAD DURING IVL, WHICH WAS TREATED WITH THE PLACEMENT OF MULTIPLE (4) DRUG ELUTING STENTS (DES). FOLLOWING DEPLOYMENT OF THE DES, IT WAS OBSERVED THAT THE MID-LAD SEPTAL BRANCH WAS COMPROMISED AND THE PATIENT EXPERIENCED CHEST PAIN DURING AND AFTER THE INDEX PROCEDURE, NECESSITATING THE USE OF NITROGLYCERIN DRIP (NTG GTT) FOR PAIN MANAGEMENT. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT FOR FURTHER MONITORING AND TREATMENT AND WAS RELEASED THREE (3) DAYS FOLLOWING THE INDEX PROCEDURE. THERE WAS NO REPORT OF AN IVL DEVICE MALFUNCTION. THE CLINICAL SITE HAS DETERMINED THAT THE RELATIONSHIP OF THE DISSECTION AND SUBSEQUENT CHEST PAIN TO BOTH THE STUDY DEVICE AND PROCEDURE WAS CAUSAL/ DEFINITE.

  Patient problems: Chest Pain; Myocardial Infarction; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 20326891 ↗