SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
Report
- Report Number
- 3015053858-2023-00060
- Event Type
- Death
- Date Received
- October 5, 2023
- Date of Event
- September 22, 2023
- Report Date
- May 23, 2025
- Manufacturer
- SHOCKWAVE MEDICAL, INC.
- Product Code
- QMG
- UDI-DI
- 00195451000102
- PMA / PMN Number
- P200039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL INC. FOR INVESTIGATION THEREFORE, NO INVESTIGATION CAN BE PERFORMED. BASED ON THE REPORTED EVENT, THE PATIENT WAS ALREADY HAVING CHEST PAIN AND WAS IN COMPLETE HEART BLOCK (CHB) WHEN SHE PRESENTED TO THE EMERGENCY ROOM AND THEN TO THE CATH LAB. THE PATIENT WAS GIVEN ATROPINE UPON ARRIVAL AT THE HOSPITAL. DURING THE IVL TREATMENT, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VFIB). THE PATIENT WAS PROVIDED SHOCK AND SINUS RHYTHM RETURNED TO NORMAL. PRIOR TO THE PATIENT BEING OFF THE TABLE, THE PATIENT CODED MULTIPLE TIMES. AN IMPELLA WAS INSERTED AND SUBSEQUENTLY, THE IVL TREATMENT WAS ULTIMATELY SUCCESSFUL. THE PATIENT WAS TRANSFERRED TO THE ICU BUT EXPIRED LATER THAT EVENING. A REVIEW OF THE LOT HISTORY RECORD (LHR) AND TEST DOCUMENTATION DID NOT SHOW ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL SHOCKWAVE MEDICAL, INC. CRITERIA PRIOR TO BEING RELEASED FOR DISTRIBUTION. SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.
SEE CORRECTION TO D4: UDI.
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 AGAIN AND RETURNED TO THE TABLE. THE PHYSICIAN DETERMINED THAT THE POSTERIOR DESCENDING ARTERY (PDA) BRANCH OFF THE RCA WAS STUMPED OFF. FURTHERMORE, THE PATIENT WAS REPORTED TO HAVE CODED SEVERAL MORE TIMES WHILE THE PHYSICIAN ATTEMPTED TO REOPEN THE PDA BRANCH. THE PROCEDURE WAS ULTIMATELY SUCCESSFUL AND AN IMPELLA WAS PLACED TO ALLOW FOR HEMODYNAMIC STABILITY AND A TEMPORARY PACEMAKER WAS ALSO INSERTED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FROM THE CATH LAB, BUT THE PATIENT EXPIRED LATER THAT EVENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2278331 | SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM | INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER | QMG | SHOCKWAVE MEDICAL, INC. | C2IVL3012 | A230113D | 00195451000102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Death | ATROPINE - ENTOD PHARMACEUTICALS LTD.| DEFIBRILLATOR - UNKNOWN MANUFACTURER| IMPELLA PERCUTANEOUS VENTRICULAR ASSIST DEVICE| NON-COMPLIANT BALLOONS - UNKNOWN MANUFACTURER| PACEMAKER - UNKNOWN MANUFACTURER| STENT - UNKNOWN MANUFACTURER |