SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
Report
- Report Number
- 3015053858-2023-00037
- Event Type
- Injury
- Date Received
- June 23, 2023
- Date of Event
- May 28, 2023
- Report Date
- March 28, 2024
- Manufacturer
- SHOCKWAVE MEDICAL, INC.
- Product Code
- QMG
- UDI-DI
- 00195451000096
- PMA / PMN Number
- P200039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO SHOCKWAVE MEDICAL, INC. AFTER THE PROCEDURE THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED PROVIDED INFORMATION, POST INDEX PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND LATER FOUND A DISSECTION. THE DISSECTION WAS TREATED WITH STENT IMPLANTATION. TWO DAYS LATER, THE PATIENT WAS REPORTED TO HAVE A HEART FAILURE REDUCED EJECTION FRACTION (EF). 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. 2ND DEVICE USED DURING THE INDEX PROCEDURE: CP-11327 LOT NUMBER: A220915D EXPIRATION DATE: 09/30/2024 MANUFACTURNG DATE: 09/15/2022.
ADDITIONAL INFORMATION RECEIVED ON 05MAR2024: A CEC ADJUDICATION HEARING WAS CONDUCTED AND IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT, UNSTABLE ANGINA, WAS ADJUDICATED AS MYOCARDIAL INFARCTION (MI). THE MI HAS BEEN CEC ADJUDICATED TO BE POSSIBLY RELATED TO THE STUDY DEVICE. THE ADVERSE EVENT OCCURRED AT THE TIME OF THE INDEX PROCEDURE. THE CAUSE OF THE MYOCARDIAL INFARCTION COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION AND THERE WAS NO MALFUNCTION REPORTED FOR THE C2 IVL CATHETERS THAT WERE USED.
IT WAS REPORTED THAT TWO SHOCKWAVE C2IVL CORONARY LITHOTRIPSY (IVL) CATHETERS WERE USED ON THIS PATIENT. REPORTEDLY, POST INDEX PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE FOR THE POST MARKET EMPOWER CAD CLINICAL STUDY, PATIENT # 112, 001 WAS REPORTED TO HAVE EXPERIENCED 9/10 CHEST PAIN RADIATING TO THE RIGHT JAW. CARDIAC ANGIOGRAM SHOWED ST DEPRESSIONS AND THE PATIENT WAS GIVEN NITROGLYCERIN BUT WITHOUT RELIEF. INTRAVENOUS TRINDIL DRIP WAS STARTED AND WHEN THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, THERE WAS A LAB DISSECTION OBSERVED. THE PHYSICIAN TREATED THE DISSECTION WITH RX STENTS X 4. THE PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU). TWO DAYS LATER, THE PATIENT WAS REPORTED TO HAVE A HEART FAILURE REDUCED EJECTION FRACTION (EF). IT WAS REPORTED TO HAVE BEEN TREATED WITH MEDICATION. ECHOCARDIOGRAM POST PCI EF WAS 40% (BASELINE WAS 64%), HEART FAILURE CONSULTED. THE PATIENT WAS WARM AND WELL PERFUSED, BUT VOLUME WAS OVERLOADED. PATIENT WAS ADVISED TO CONTINUE CARDIAC MEDICATION (HYDRALAZINE) TO ALLOW FOR INCREASE FLUID REMOVAL. THE PATIENT'S EF WAS ALSO ASSOCIATED WITH ORTHOPNEA (SENSATION OF BREATHLESSNESS).
ADDITIONAL INFORMATION RECEIVED ON 05MAR2024: A CEC ADJUDICATION HEARING WAS CONDUCTED AND IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT, UNSTABLE ANGINA, WAS ADJUDICATED AS MYOCARDIAL INFARCTION (MI). THE MI HAS BEEN CEC ADJUDICATED TO BE POSSIBLY RELATED TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1279206 | SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM | INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER | QMG | SHOCKWAVE MEDICAL, INC. | C2IVL3012 | A220915D | 00195451000096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Other |