Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3512Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00195451000102), received between May 11, 2021 and Nov 25, 2024 — classified as 7 deaths, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED TO TREAT A LESION IN THE CORONARY ARTERIES. THIS REPORT IS FOR THE SECOND CATHETER USED IN THE PROCEDURE. REFER TO MDR# 3015053858-2024-00130 FOR THE FIRST CATHETER. BOTH CATHETERS SUCCESSFULLY DELIVERED 80 PULSES AT 4 ATM. DURING THE DELIVERY OF THE IVL CATHETER TO THE LESION, NO ISSUES WERE OBSERVED AT THE TREATMENT SITE, BUT HEMATOMA WAS OBSERVED AT A DISTANT SITE. A 3.0MM XIENCE STENT WAS IMPLANTED FOLLOWING IVL TREATMENT. UPON POST-DILATION OF THE STENT USING A 4.5MM NC BALLOON, A VESSEL RUPTURE OCCURRED. THE PHYSICIAN STATED THAT THE VESSEL WAS HIGHLY CALCIFIED, AND THE DIAMETER OF THE NC BALLOON WAS TOO LARGE. HEMOSTASIS WAS ATTEMPTED WITH A RYUSEI BALLOON CATHETER AND COVERED STENT BUT WAS UNSUCCESSFUL, SO THE PATIENT WAS TRANSFERRED TO SURGERY. A CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED ALONGSIDE AN AORTIC STENOSIS ( AS) AND AORTA ASCENDENS (AA) REPLACEMENT OPERATION. THE SURGERY WAS COMPLETED WITH NO ISSUES AND THE PATIENT IS CURRENTLY STABLE AND HOSPITALIZED IN THE ICU. THE PHYSICIAN STATED THAT IVL COULD BE AN INDIRECT CAUSE OF THE VESSEL PERFORATION, BUT IT IS UNKNOWN AND UNLIKELY. T

  Patient problems: Perforation of Vessels

  MAUDE report 20773676 ↗
• MalfunctionMay 23, 2024

  PRE-PROCEDURE EXAM: 5 OUT OF 10 CHEST PAIN WITH ELECTROCARDIOGRAM (EKG) SHOWING INFERIOR WALL ST-ELEVATION. AFTER GETTING VERBAL INFORMED CONSENT, THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. ACCESS OBTAINED INTO THE RIGHT RADIAL ARTERY. TEAM WAS WORKING ON THE MID RIGHT CORONARY ARTERY LESION. PER REPORT: USE OF 3.5 X 12 SHOCKWAVE BALLOON WAS ATTEMPTED DURING ST ELEVATION MYOCARDIAL INFARCTION (STEMI) PROCEDURE; HOWEVER, THE BALLOON WAS DEFECTIVE AND COULD NOT BE INFLATED AND DYE EXITED THROUGH THE BALLOON. AT THIS POINT ANOTHER SHOCKWAVE BALLOON WAS SUCCESSFULLY BROUGHT ACROSS THE ENTIRE LESION. THE PROCEDURE WAS THEN COMPLETED WITH NO FURTHER INCIDENT. OUTCOME: SUCCESSFUL SHOCKWAVE AND BALLOON ANGIOPLASTY OF THE MID RIGHT CORONARY ARTERY HEAVILY CALCIFIED LESION, WITH THE LESION BEING REDUCED FROM 99% TO 50% WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI)-3 FLOW. MANUFACTURER RESPONSE FOR SHOCKWAVE INTRAVASCULAR LITHOTRIPSY SYSTEM, SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY IVL CATHETER (PER SITE REPORTER). DEFECTIVE DEVICE GIVEN TO FIELD REPRESENTATIVE.

  Patient problems: Chest Pain

  MAUDE report 19380641 ↗
• DeathNov 28, 2023Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY USING A SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. PRIOR TO THE PROCEDURE, THE TARGET LESION WAS PRE-DILATED WITH A NON-COMPLIANT (NC) BALLOON. WHEN THE IVL WAS ADVANCED TOWARDS THE TARGET LESION, IT WAS UNABLE TO CROSS SO A STENT WAS PLACED IN THE LCX AND POST DILATED WITH A 3.5MM NON-COMPLIANT (NC) BALLOON. THE PHYSICIAN WANTED MORE EXPANSION SO A 4.0MM NC BALLOON WAS USED AND IMMEDIATELY, A PERFORATION WAS OBSERVED PROXIMAL TO THE LESION. THE NC BALLOON WAS USED TO TAMPONADE THE VESSEL HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO USE A COVERED STENT BUT COULDN'T GO IN DUE TO THE STENT AND SEVERE ANGULATION. THE PATIENT WAS TRANSFERRED TO SURGERY IN AN ATTEMPT TO REPAIR THE AORTIC VALVE HOWEVER, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE PATIENT'S DEATH WAS NOT DUE TO THE IVL. IT WAS DUE TO THE PATIENT'S ANATOMY AND VESSEL CALCIFICATION ALONG WITH THE COMPLICATIONS DURING SURGICAL VALVE REPAIR THAT ULTIMATELY CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Perforation of Vessels

  MAUDE report 18223024 ↗
• DeathOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND WAS IN COMPLETE HEART BLOCK (CHB). THE PATIENT WAS GIVEN ATROPINE UPON ARRIVAL AT THE HOSPITAL. THE PATIENT WAS TRANSFERRED TO THE CATH LAB WITH NORMAL SINUS RHYTHM WITH STABLE VITAL SIGNS AND THEN UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE PHYSICIAN IDENTIFIED A BLOCKAGE IN THE RIGHT CORONARY ARTERY (RCA) AND PREDILATED IT WITH A NON-COMPLAINT (NC) BALLOON, HOWEVER THE PHYSICIAN WAS UNABLE TO PASS A STENT. THE PHYSICIAN REQUESTED A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER. ACCORDINGLY, THE BALLOON DELIVERED SEVERAL CYCLES, HOWEVER DURING THE LAST CYCLE OF PULSES, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VFIB). THE PATIENT WAS SHOCKED WITH A DEFIBRILLATOR AND HEARTBEAT RETURNED TO NORMAL SINUS RHYTHM. AT THAT POINT, THE CALCIUM HAD BEEN MODIFIED ENOUGH BY THE IVL AND A STENT WAS ABLE TO BE ADVANCED TO THE LESION AND WAS SUBSEQUENTLY DEPLOYED. AFTER POST DILATATION OF THE STENT, THE PROCEDURE WAS ULTIMATELY COMPLETED. THE PATIENT WAS TRANSFERRED OFF THE TABLE HOWEVER, THE PATIENT CODED AGAIN BEFORE LEAVING THE CATH LAB. THE PATIENT WAS SHOCKED ONCE

  Patient problems: Arrhythmia; Ventricular Fibrillation

  MAUDE report 17876611 ↗
• DeathAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT ANTERIOR DESCENDING (LAD) AND CIRCUMFLEX (CX) ARTERIES AND THE LEFT MAIN (LM) DUE TO HEAVY CALCIUM AS DETERMINED BY OPTICAL COHERENCE TOMOGRAPHY (OCT) AND POST ORBITAL ATHERECTOMY. ARTERIAL ACCESS TO THE TARGET LESION WAS OBTAINED VIA THE FEMORAL ARTERY. ORBITAL ATHERECTOMY WAS PERFORMED ALONG WITH HIGH PRESSURE BALLOON INFLATIONS AND THE PATIENT'S RHYTHM CHANGED AFTER SEVERAL INFLATIONS AND PULSE CYCLES WITH THE SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON. REPORTEDLY, DURING THE IVL TREATMENT, THE PATIENT LOST CONDUCTION FROM A LEFT BUNDLE BRANCH BLOCK (LBBB) THAT DISRUPTED THE ELECTRICAL IMPULSE TO CAUSE THE HEART TO BEAT. A TEMPORARY PACEMAKER WAS INSERTED, AND THE PROCEDURE CONTINUED AS PLANNED. IT TOOK ONLY A FEW MINUTES TO INSERT THE PACEMAKER AFTER THE CONDUCTION WAS LOST. THE PACEMAKER WAS NOT REMOVED AFTER THE PCI AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT SEVERAL DAYS AFTER THE PROCEDURE, THE PATIENT EXPIRED OF UNRELATED COMPLICATIONS. THE PHYSICIAN WAS ADAMANT THAT IVL WAS NOT THE CAUSE OF THE PATIENT'S LOSS OF COND

  Patient problems: Arrhythmia

  MAUDE report 17631989 ↗
• MalfunctionApr 17, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IIT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRIOR TO THE START OF PROCEDURE, THE LESION WAS PRE-DILATED USING A NON-COMPLIANT (NC) BALLOON. THEN A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS ADVANCED TOWARDS THE TARGET VESSEL AND SUCCESSFULLY DELIVERED 80 PULSES TO THE TARGET LESION. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE IVL FROM THE PATIENT'S ANATOMY, RESISTANCE WAS ENCOUNTERED. AS THE IVL WAS BEING WITHDRAWN, THE BALLOON WAS CAUGHT IN THE TELEFLEX GUIDELINER AND IT SUBSEQUENTLY BROKE. THE INITIAL BREAK OCCURRED AT THE DISTAL TIP OF THE GUIDELINER, BUT THE COMPLETE SEPARATION WAS REPORTED TO BE INSIDE BUT COULD NOT BE DEFINITIVELY DETERMINED AS THE STAFF WAS NOT USING LIVE IMAGING UPON PULLING OUT THE CATHETER. THE PHYSICIAN USED SPECTRE¿ GUIDEWIRE TO SUCCESSFULLY RETRIEVE THE FRAGMENT(S) FROM THE GUIDELINER WHILE IT WAS STILL INSIDE THE PATIENT. POST IVL PROCEDURE, THE LESION WAS EXPANDED WITH A SYNERGY DRUG-ELUTING STENT (DES). THERE WERE NO PATIENT CL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751755 ↗
• MalfunctionDec 9, 2022Gas/Air Leak

  DURING AN INTERVENTIONAL PROCEDURE IN CARDIAC CATHETER LAB, SHOCKWAVE LITHOTRIPSY DEVICE WAS PREPPED OUTSIDE OF PATIENT'S BODY SUCCESSFULLY AND THEN DEVICE ADVANCED INTO PATIENT'S ARTERY. THE PREPPING SYRINGE WAS REMOVED AND THE STOPCOCK WAS ATTACHED TO THE INFLATION DEVICE. WHEN THE INFLATION DEVICE PULLED NEGATIVE ON DEVICE, AIR KEPT BEING PULLED OUT OF SHOCKWAVE (BALLOON). THE STOPCOCK AND THE INFLATION DEVICE WERE THEN REPLACED WITH NEW STOPCOCK AND NEW INFLATION DEVICE AND AIR WAS STILL COMING OUT. DOCTOR DID NOT WANT TO USE THIS DEVICE. DEVICE REMOVED AND NO HARM DONE TO PATIENT. A NEW SHOCKWAVE DEVICE WAS USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949587 ↗
• DeathJul 22, 2022Decrease in Pressure; Difficult to Advance; Decrease in Pressure; Difficult to Advance

  A C2 IVL CORONARY CATHETER WAS USED TO TREAT A CALCIFIED CORONARY ARTERY. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PASS A 3.0 NON COMPLIANT BALLOON(NC) PRIOR TO USING SHOCKWAVE IVL CATHETER, WHICH WOULDN'T PASS. NEXT, PHYSICIAN THEN USED A 1.5 BURR ROTA AND THEN A 3.0 NC. IT WAS THEN NOTED THAT A DISSECTION FLAP OCCURRED FROM THE ROTABLATOR. PHYSICIAN THEN PLACED A 5.5 GUIDELINER AND DELIVERED A 3.5 C2 IVL CATHETER AND TREATED A SEGMENT PAST WHERE HE USED ROTA. IT WAS NOTED THAT A LOSS OF PRESSURE OCCURRED IN THE IVL CATHETER. PHYSICIAN THEN PLACED A 3.25 X 38 AND 3.25 X 15 XIENCE AND THEN PASSED IVUS. AFTER THAT, PHYSICIAN POST DILATED WITH A 3.5 X 25 NC AND THEN A 4.0 X 20 NC. THE PERFORATION OF VESSEL OCCURRED AFTER THE 4.0X20 NC. ANGIOGRAPHY AFTER THESE STEPS SHOWED PERFORATION IN THE MID LAD. BALLOON WENT UP AND PAPYRUS STENT(S) WERE DEPLOYED. PHYSICIAN'S PERSPECTIVE ON WHAT MAY HAVE CAUSED THE EVENT IS UNSURE BUT FELT THAT THE CALCIUM IN THE AREA TREATED WITH THE IVL CATHETER WAS STALACTITE IN COMPOSITION. THIS CREATED A LOSS IN PRESSURE IN THE IVL CATHETER, AND THEN PROTRUDED THROUGH THE VESSEL WALL WHEN POST DILATED WITH THE 4.0 BALLOON. IT WAS REPORTED THAT THE PAT

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 15085942 ↗
• MalfunctionJul 8, 2022Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A C2 IVL CORONARY CATHETER WAS USED IN A CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE IVL CATHETER TO THE POINT OF THE DISTAL LESION. IT WAS NOTED THAT THERE WERE TWO GUIDEWIRES IN THE VESSEL ALONG WITH A GUIDELINER SHEATH, AND THE IVL CATHETER DID TRAVEL THROUGH PRE-EXISTING STENTS UPON TRYING TO DELIVER TO THE LESION. THE DOCTOR THEN ATTEMPTED TO TREAT THE PROXIMAL PART OF THE LESION WITH A SHOCK AND GO TECHNIQUE WITHOUT SUCCESS. THE PHYSICIAN ATTEMPTED TO REMOVE THE IVL BALLOON SO A NON-COMPLIANT BALLOON COULD BE USED. UPON ATTEMPTS TO WITHDRAWAL THE IVL CATHETER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE BALLOON GOT STUCK IN THE GUIDELINER. THE PHYSICIAN BELIEVES THAT THE ARCH OF THE GUIDELINER WAS AT AN ACUTE ANGLE AND COULD NOT REMOVE THE BALLOON FROM THE GUIDELINER, THEREFORE THE GUIDEWIRE, GUIDELINER, AND IVL CATHETER WAS REMOVED TOGETHER AS ONE. THE TIP WAS PARTIALLY SEPARATED BUT DEVICES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NOTHING FROM THE IVL CATHETER REMAINED IN THE BODY. DOCTOR PROCEEDED WITH USING A COUPLE OF NON-COMPLIANT BALLOONS AND THEN DECIDED TO USE A 4.0 IVL CATHETER THAT WAS SUCCESSFUL IN DELIVERY AND TREATMENT. FOLLOWING IVL, A DES ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957638 ↗
• DeathFeb 9, 2022Adverse 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 THE RIGHT CORONARY ARTERY (RCA) OF A DE NOVO LESION WITH CONCENTRIC CALCIUM. IVUS WAS USED BUT COULD NOT PASS. IVUS WAS THEN FOLLOWED BY A 2.5MM NON-COMPLIANT (NC) BALLOON, WHICH SUCCESSFULLY CROSSED, AND IVUS WAS THEN SUCCESSFULLY USED. THE SHOCKWAVE IVL CATHETER WAS ADVANCED BUT DID NOT CROSS THE LESION. A 2.5 NC BALLOON WAS THEN USED WITH A GUIDELINER INSIDE A GUIDE FOR ADDITIONAL GUIDE SUPPORT. THE IVL CATHETER WAS THEN ABLE TO BE DELIVERED TO THE TIGHTEST PART OF THE LESION; HOWEVER, COULD NOT REACH THE MOST DISTAL SECTION. FOLLOWING IVL TREATMENT, THE VESSEL WAS PATENT WITH NO EVIDENCE OF DISSECTIONS OR PERFORATIONS. IT WAS NOTED THAT THE SHOCKWAVE DEVICE WAS THE LAST DEVICE IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST NECESSITATING RESUSCITATION TWICE DURING THE PROCEDURE, AND THE PATIENT SUBSEQUENTLY EXPIRED. THE PHYSICIAN DOES NOT BELIEVE THE SHOCKWAVE IVL WAS THE CAUSE OF THE PATIENT'S PASSING BUT THOUGHT IT WAS POSSIBLE THERE WAS A THROMBUS CAUSED BY OTHER NON-SHOCKWAVE GEAR, AND A POSSIBLE HEPARIN ISSUE. THE EVENT IS LIKELY RELATED TO THE PROCEDURE, BUT NOT TH

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 13502077 ↗
• DeathDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A HEAVILY CALCIFIED DE NOVO LESION AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN PRE-DILATED THE LESION WITH TWO DIFFERENT SIZED BALLOONS AND THEN ACTIVATED THE IVL BALLOON CATHETER. IT SUCCESSFULLY DELIVERED 40 PULSES AT 4 ATMOSPHERES FOLLOWED BY A SUCCESSFUL PROMUS DRUG-ELUTING STENT (DES) PLACEMENT. AFTER POST DILATATION OF THE STENT USING A 3.5 MM NON-COMPLIANT (NC) BALLOON, THE PHYSICIAN REALIZED THERE WAS AN ARTERIAL PERFORATION. IT WAS REPORTED THAT THE PATIENT REFUSED TO UNDERGO A CORONARY ARTERY BYPASS GRAFT (CABG). THE PATIENT OPTED FOR AN ENDOVASCULAR APPROACH. THE PHYSICIAN INSERTED A BALLOON CATHETER TO TAMPONADE THE BLEEDING FOLLOWED BY A COVERED STENT PLACEMENT. AT THIS TIME, CARDIOPULMONARY RESUSCITATION (CPR) BEGAN, BUT THE PATIENT DID NOT MAKE IT AND EXPIRED ON THE TABLE. THE PHYSICIAN BELIEVES THAT THE IVL BALLOON CATHETER PERFORMED WELL, AND IT DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 12913137 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A COMPLETE TOTAL OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). PATIENT IS (B)(6) FEMALE WITH EXTENSIVE CARDIAC HISTORY INCLUDING CORONARY ARTERY BYPASS GRAFT SURGERY (CABG), AND AN RCA GRAFT THAT IS NO LONGER PATENT. BILATERAL FEMORAL ACCESS WAS OBTAINED AND AN ANTEGRADE AND RETROGRADE ACCESS TO THE RCA OCCLUSION WAS OBTAINED. AFTER THE GUIDEWIRE WAS ABLE TO CROSS THE LESION, SERIAL DILATION OF THE MID/PROX SEGMENT WAS MADE USING A 2.0 AND 2.5 BALLOON. IVUS WAS PERFORMED TO ANALYZE THE LESION AND MORPHOLOGY. A 3.5 NON-COMPLIANT (NC) BALLOON WAS USED TO DILATE THE LESION FURTHER. A 3.5X12 IVL CATHETER WAS THEN SELECTED TO MODIFY THE LESION BASED ON THE CALCIUM BURDEN. THE ENERGY WAS DELIVERED IN THE PROX/MID RCA, INSIDE A CHRONICALLY UNDER EXPANDED STENT, WHICH IS OFF-LABEL FOR THE SHOCKWAVE IVL DEVICE, AND 40 PULSES WERE DELIVERED USING THE 4ATM/6ATM RHYTHM. AFTER THE 40TH PULSE, THE PATIENT TRANSITIONED INTO VENTRICULAR FIBRILLATION. THE PATIENT WAS SHOCKED 1 TIME AT 360J AND THE RHYTHM RETURNED TO NORMAL SINUS RHYTHM. ONCE THE PATIENT HAD RECOVERED, THE IVL CATHETER WAS RETURNED TO THE LESION A

  Patient problems: Ventricular Fibrillation

  MAUDE report 12627525 ↗
• DeathJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 CORONARY LITHOTRIPSY (IVL) DEVICE WAS SUCCESSFULLY USED TO TREAT A PATIENT WITH HEAVY, RESISTANT CALCIUM IN THE CORONARY. IT WAS NOTED THAT A SEMI-COMPLIANT BALLOON DID NOT WORK, AND IVL WAS USED WITH GOOD ACUTE RESULTS. THE SHOCKWAVE DEVICE WAS REPORTED TO ADEQUATELY RESOLVE THE CORONARY STENOSIS FOLLOWING IVL TREATMENT AND STENT IMPLANTATION, GAINING THE EFFECTIVE REFERENCE VESSEL LUMEN. THE PHYSICIAN USED A CUTTING BALLOON PRIOR TO THE SHOCKWAVE DEVICE. THERE WERE NO CLINICAL AND ANGIOGRAPHIC EVENTS DETECTED DURING THE ENTIRE SHOCKWAVE PROCEDURE. APPROXIMATELY 30 MINUTES FOLLOWING SHOCKWAVE IVL, THE PATIENT EXPERIENCED AN ELECTROMECHANICAL DISSOCIATION (CARDIAC ARREST) AND SUBSEQUENTLY EXPIRED. THE PATIENT'S FAMILY REFUSED AN AUTOPSY THEREFORE THE EXACT CAUSE OF DEATH IS UNKNOWN. THE OPERATORS OF THE DEVICE BELIEVE THAT SHOCKWAVE WAS NOT AT FAULT AS THE RESULT AFTER THE PROCEDURE WAS GOOD. THE PATIENT'S FAMILY REFUSED AN AUTOPSY SO THE PHYSICIANS ARE NOT CLEAR AS TO THE CAUSE OF DEATH.

  Patient problems: Cardiac Arrest

  MAUDE report 12081394 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE C2 3.5MM X 12MM INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE WAS USED TO TREAT A COMPLETE OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS DONE WITH LOCAL ANESTHESIA VIA ANTEGRADE RETROGRADE ACCESS THROUGH THE SEPTAL BRANCHES, AND VERY SMALL VESSELS (~1MM). IT WAS NOTED THAT IT TOOK THE PHYSICIAN OVER TWO (2) HOURS TO CROSS THE LESION, AND MULTIPLE ACCESSORY DEVICES WERE USED DURING THE WHICH INCLUDED A STINGRAY DEVICE, MULTIPLE CROSSING WIRES AND NON-COMPLIANT (NC) BALLOONS. THE SHOCKWAVE DEVICE APPEARED TO SUCCESSFULLY YIELD THE LESION. FOLLOWING IVL TREATMENT, 'CAPTURE' WAS OBSERVED AND A DROP IN BLOOD PRESSURE INDICATING A PERFORATION OF THE VESSEL, AND THE PHYSICIAN PROCEEDED WITH THE PLACEMENT OF A SYNERGY STENT (BOSTON SCIENTIFIC'S DRUG ELUDING STENT). THE BALLOON PRESSURE TO DELIVER THE SYNERGY STENT IS UNKNOWN. AT THAT TIME A PERFORATION WAS OBSERVED, FOLLOWING THE PLACEMENT OF THE STENT. IT WAS NOTED THAT DUE TO THE CHALLENGING ACCESS AND VIEW, IMAGES COULD NOT BE TAKEN AFTER IVL AND BEFORE THE SYNERGY STENT PLACEMENT TO CONFIRM WHEN THE PERFORATION OCCURRED. THE PHYSICIAN ELECTED TO PLACE FIVE (5) COVERED STENTS (PAPYRUS - BIOTRONIK, INC) AT TH

  Patient problems: Perforation of Vessels

  MAUDE report 11809611 ↗