HEARTMATE 3 LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2022-16018
- Event Type
- Injury
- Date Received
- December 21, 2022
- Date of Event
- November 30, 2022
- Report Date
- March 10, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Removal / Correction Number
- FA-Q124-HF-1
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
VOLUNTARY MEDWATCH #(B)(4) WAS RECEIVED ON 03JAN2023. RELATED MFR # 2916596-2023-00547 AND # 2916596-2022-16139. MANUFACTURER'S INVESTIGATION CONCLUSION: NO DEVICE-RELATED ISSUES WERE IDENTIFIED DURING THE EVALUATION OF HEARTMATE 3 LVAS, (B)(6), THAT WOULD HAVE CONTRIBUTED TO THE REPORTED PUMP EXCHANGE DUE TO INFECTION. FURTHERMORE, A SPECIFIC CAUSE FOR THE REPORTED INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 9.5 INCHES FROM THE PUMP HEADER, AND A DISTAL SEGMENT MEASURING APPROXIMATELY 16 INCHES WAS ALSO RETURNED. THE MODULAR CABLE WAS RETURNED ATTACHED AT THE INLINE CONNECTOR AND IS INVESTIGATED UNDER PI-2022-0191853-02. THE SEALED OUTFLOW GRAFT AND BEND RELIEF WERE RETURNED DETACHED FROM THE PUMP COVER OUTLET PORT. THE APICAL CUFF WAS NOT RETURNED, AND THE CUFF LOCK WAS DISENGAGED. UPON DISASSEMBLY OF THE RETURNED PUMP ,EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO ADHERED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FLOW OR FUNCTIONAL ISSUE. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL DID NOT REVEAL ANY OBVIOUS SURFACE SCRATCHES OR DEFECTS. THE LVAD EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. (B)(6) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. INCIDENTAL FINDING: A RIDGE-LIKE CREASE IN THE OUTFLOW GRAFT WAS OBSERVED AT THE PROXIMAL PORTION OF THE OUTFLOW GRAFT, FROM APPROXIMATELY 0.5 INCHES FROM THE OUTFLOW GRAFT HARDWARE TO APPROXIMATELY 3.5 INCHES FROM THE OUTFLOW GRAFT HARDWARE. TISSUE ACCUMULATION WAS PRESENT WITHIN THE DEFORMATION THAT FILLED IN THE SPACE TO THE INNER LUMEN OF THE BEND RELIEF, WHICH IS CONSISTENT WITH AN EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO) AND APPEARED TO BE PRESENT DURING PATIENT SUPPORT. THE EOGO DID NOT APPEAR TO HAVE CONTRIBUTED TO A FLOW OR FUNCTIONAL ISSUE AS THERE WAS NO DEPOSITION THROUGHOUT THE REST OF THE DEVICE TO SUGGEST A FLOW ISSUE, AND THE LOG FILES SHOWED THE PUMP OPERATING AS INTENDED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA (QUALITY ASSURANCE) SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE IFU LISTS INFECTION (DRIVELINE, LOCALIZED, AND PUMP POCKET OR PSEUDO POCKET) AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE INCLUDED IN SEVERAL SECTIONS OF THE IFU, INCLUDING IN SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "CAUTION!", "CARING FOR THE DRIVELINE EXIT SITE", AND "CONTROLLING INFECTION"). SECTION 6 ALSO PROVIDES SUGGESTED RESPONSES IN THE EVENT OF INFECTION. THE IFU CONTAINS A SECTION ENTITLED ¿PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS HOW TO ATTACH THE SEALED OUTFLOW GRAFT TO THE AORTA. ALSO IN THIS SECTION, "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". THE HEARTMATE 3 LVAS PATIENT HANDBOOK PROVIDES CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION IN SEVERAL SECTIONS, INCLUDING SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ (UNDER ¿CARING FOR THE DRIVELINE EXIT SITE¿). THE PATIENT HANDBOOK INSTRUCTS THE PATIENT TO CALL THEIR HOSPITAL CONTACT IMMEDIATELY IF ANY SIGNS OF INFECTION ARE NOTICED. SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE INFECTION WITH CULTURES POSITIVE FOR PROTEUS MIRABILIS. THEY UNDERWENT A PUMP EXCHANGE ON (B)(6) 2022, AND THE INFECTION RESOLVED.
IT WAS REPORTED THAT THE PATIENT QUICKLY DEVELOPED A PROTEUS DRIVELINE INFECTION IN AND HAD BEEN MAINTAINED ON ANTIBIOTICS. THE PATIENT ALSO DEVELOPED SEVERE AORTIC INEFFICIENCY IN 2022 AND WAS NOT A CANDIDATE FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TVAR) DUE TO LARGE ANNULUS SIZE. THEY UNDERWENT AN OPEN AORTIC VALVE REPLACEMENT AND HEARTMATE 3 PUMP EXCHANGE DUE TO THE DRIVELINE INFECTION WITH AN UNREMARKABLE POST OPERATIVE COURSE. THE PATIENT WAS DISCHARGED (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1880282 | HEARTMATE 3 LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 7447934 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| H |