HEARTMATE 3 LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2023-04581
- Event Type
- Death
- Date Received
- July 13, 2023
- Date of Event
- October 20, 2023
- Report Date
- January 17, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), DID NOT REVEAL ANY DEVICE-RELATED ISSUES. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. FURTHERMORE, A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE FULLY INTACT. THE MODULAR CABLE WAS ALSO RETURNED DETACHED FROM THE PUMP CABLE INLINE CONNECTOR. THE SEALED OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE OUTFLOW GRAFT BEND RELIEF ENGAGED TO THE GRAFT HARDWARE. THE SEALED OUTFLOW GRAFT AND SEALED OUTFLOW GRAFT BEND RELIEF HAD BEEN SEVERED NEAR THEIR HARDWARE. THE REMAINDER OF THE GRAFT AND BEND RELIEF MATERIAL WAS NOT RETURNED. THE APICAL CUFF WAS RETURNED SECURED WITH THE CUFF LOCK FULLY ENGAGED. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL DID NOT REVEAL ANY OBVIOUS SURFACE SCRATCHES OR DEFECTS. THE LEFT VENTRICULAR ASSIST DEVICE EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. THE DEVICE WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) (REV. A) AND THE HEARTMATE 3 PATIENT HANDBOOK (REV. C) ARE CURRENTLY AVAILABLE. THE IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING STROKE, BLEEDING, RESPIRATORY FAILURE, INFECTION (LOCALIZED, DRIVELINE, PUMP POCKET OR PSEUDO POCKET), RENAL DYSFUNCTION, AND DEATH THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE IFU OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING THE INTERNATIONAL NORMALIZED RATIO (INR) RANGE FOR PATIENTS USING THE HEARTMATE 3 LVAS, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THESE SECTIONS STATE TO "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." FURTHERMORE, SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
E1 - REPORTER PHONE NUMBER (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
IT WAS NOTED THAT THE PATIENT WAS NOT ON THEIR ANTICOAGULANT MEDICATIONS, WARFARIN AND ASPIRIN, DURING THE EVENT AS THEY HAD BEEN ADMINISTERED UNTIL THE DAY BEFORE. BETWEEN FOUR TO EIGHT UNITS OF RED CELL CONCENTRATE WERE ADMINISTERED.
IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD A POSITIVE BLOOD CULTURE FOR A BACTERIAL INFECTION ON (B)(6) 2023; DRUG THERAPY WAS PROVIDED. THE PATIENT EXPERIENCED A MAJOR BACTERIAL INFECTION IN THEIR LUNGS ON (B)(6) 2023; DRUG THERAPY WAS PROVIDED, BUT THE INFECTION LED TO THE ACUTE EXACERBATION OF RENAL FAILURE ON (B)(6) 2023. THE PATIENT'S CREATININE LEVELS WERE 3.25 MG/DL; DIALYSIS WAS NOT PERFORMED. THE PATIENT PASSED AWAY ON (B)(6) 2023. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS EXPECTED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRACRANIAL BLEED IN THEIR LEFT HEMISPHERE ON (B)(6) 2022. THE PATIENT EXPERIENCED SPASMS. THE EVENT WAS DIAGNOSED THROUGH A COMPUTERIZED TOMOGRAPHY (CT) SCAN. AN ANTICONVULSANT AGENT WAS ADMINISTERED, AND THE PATIENT WAS INTUBATED. THE EVENT WAS POTENTIALLY CAUSED BY LOW BLOOD PRESSURE DURING SURGERY OR THE PATIENT'S SHAGGY AORTA, THEIR PRIMARY DISEASE. THE PATIENT DEVELOPED PNEUMONIA ON (B)(6) 2022. THE PNEUMONIA WAS SUSPECTED TO BE ASSOCIATED TO THE RESPIRATOR USED DURING THE PUMP EXCHANGE. DRUG THERAPY WAS PROVIDED. THE PATIENT WAS NOTED TO HAVE BEEN INTUBATED FOR 21 DAYS DUE TO THEIR CEREBRAL INFARCTION. THE PATIENT LATER DEVELOPED RESPIRATORY FAILURE ON AN UNKNOWN DATE; A TRACHEOSTOMY WAS PERFORMED. ON (B)(6) 2022, THE PATIENT DEVELOPED MAJOR BLEEDING IN THEIR LUNGS DURING THE PLACEMENT OF A DRAINAGE TUBE IN THEIR LEFT THORACIC CAVITY. IT WAS NOTED THAT THE PATIENT WAS NOT ON THEIR ANTICOAGULANT MEDICATIONS DURING THE EVENT AS THEY HAD BEEN ADMINISTERED UNTIL THE DAY BEFORE. A BLOOD TRANSFUSION WAS ADMINISTERED. ON (B)(6) 2023, THE PATIENT¿S BLOOD CULTURE WAS POSITIVE FOR INFECTION; DRUG THERAPY WAS PROVIDED. THE PATIENT WAS STILL HOSPITALIZED AS OF (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282004 | HEARTMATE 3 LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 7987402 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Death| R| L| H |