THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Report
- Report Number
- 2916596-2024-06858
- Event Type
- Injury
- Date Received
- November 1, 2024
- Date of Event
- October 8, 2024
- Report Date
- January 30, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024011224
- PMA / PMN Number
- P060040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
SECTION D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
D4 - UDI: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED EVENTS WHICH APPEARED TO BE CONSISTENT WITH A POTENTIAL ISSUE WITH THE DRIVELINE; HOWEVER, EVALUATION OF THE RETURNED PORTIONS OF THE DRIVELINE DID NOT CONFIRM ANY WIRE DAMAGE THAT WOULD HAVE CONTRIBUTED TO THESE EVENTS. THE SUBMITTED LOG FILE CAPTURED TRANSIENT LOW SPEED AND PUMP STOP EVENTS BETWEEN 07:36 AND 08:10 ON (B)(6) 2024 WHILE THE PATIENT WAS SUPPORTED BY BATTERY POWER. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. BASED ON PREVIOUS COMPLAINT HISTORY, THESE EVENTS APPEARED CONSISTENT WITH POTENTIAL DRIVELINE WIRE COMPROMISE. A DISTAL END OF THE DRIVELINE WAS INITIALLY RETURNED FOLLOWING THE EXTERNAL DRIVELINE REPAIR, MEASURING APPROXIMATELY 23¿ FROM THE CONTROLLER CONNECTOR. (B)(6) WAS LATER RETURNED FOLLOWING THE REPORTED PUMP EXCHANGE. THE DEVICE WAS RETURNED ASSEMBLED WITH THE DRIVELINE SEVERED APPROXIMATELY 1.5¿ FROM THE PUMP HOUSING. ANOTHER DISTAL PORTION OF THE DRIVELINE CONTAINING THE DRIVELINE REPAIR SITE WAS ALSO RETURNED WITH THE DEVICE, MEASURING APPROXIMATELY 26¿ FROM THE CONTROLLER CONNECTOR. THE OUTLET ELBOW WAS RETURNED ATTACHED TO THE PUMP OUTLET PORT. THE SEALED INFLOW CANNULA (INLET EXTENSION, FLEX SECTION, INLET ELBOW), APICAL SEWING RING, SEALED OUTFLOW GRAFT, AND SEALED OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED WITH THE DEVICE. UPON DISASSEMBLY OF (B)(6), VISUAL INSPECTION OF THE BLOOD CONTACTING SURFACES WITHIN THE PUMP REVEALED NO DEPOSITIONS OR THROMBUS FORMATIONS. THE PUMP WAS CLEANED, AND THE BEARINGS, ROTOR AND BLOOD CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE. NO ANOMALIES WERE OBSERVED THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. THE DRIVELINE PORTIONS WERE TESTED FOR ELECTRICAL CONTINUITY AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. MICROSCOPIC INSPECTION OF THE UNDERLYING WIRES REVEALED NO EVIDENCE OF ANY BREACHES OR DAMAGE TO THE WIRE INSULATION OR UNDERLYING CONDUCTORS. UPON DISASSEMBLY, THE DRIVELINE PORTIONS WERE THEN SUBMERGED IN A SALINE BATH FOR HIGH POTENTIAL TESTING TO VERIFY THE INTEGRITY OF EACH WIRE¿S INSULATION. THIS TEST DID NOT REVEAL ANY AREAS OF CURRENT LEAKAGE. IT SHOULD BE NOTED THAT A PORTION OF THE DRIVELINE WAS NOT RETURNED FOR EVALUATION. THE HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C AND THE HEARTMATE II PATIENT HANDBOOK REV. C ARE CURRENTLY AVAILABLE. SECTIONS 6 AND 8 OF THE HMII IFU, AS WELL AS SECTIONS 4 AND 6 OF THE HMII PATIENT HANDBOOK, PROVIDE INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE; HOWEVER, HEARTMATE II DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON DURATION OF USE AND MOVEMENT/FLEXING OVER TIME. THESE DOCUMENTS ADDRESS DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE AND OUTLINE INDICATIONS OF DRIVELINE DAMAGE, AS WELL AS THE HOW TO RESPOND TO SUCH EVENTS. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, OUTLINE SYSTEM CONTROLLER ALARMS AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. THE PATIENT HANDBOOK ALSO CONTAINS A SECTION ON HANDLING EMERGENCIES AND FURTHER INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT IF THE PATIENT THINKS THAT, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT PATIENT PRESENTED VIA EMERGENCY MEDICAL SERVICES (EMS) TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LOW FLOWS AND DIZZINESS. UPON INTERROGATION, IT WAS NOTED THEY HAD SEVERAL PUMP STOPS BETWEEN 07:36 AND 08:10. THE PATIENT ENDORSED SLEEPING ON BATTERIES. HOWEVER, THEY WERE ADAMANT THE BATTERIES WERE ADEQUATELY CHARGED AND DENIED DISCONNECTING BOTH POWER LEADS SIMULTANEOUSLY. PER PROVIDER, NO ABNORMAL SOUNDED ON AUSCULTATION. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) CHEST, ABDOMEN, PELVIS, KIDNEYS, URETERS, AND BLADDER HAD BEEN ORDERED FOR FURTHER EVALUATION. LOG FILE CAPTURED NUMEROUS PUMP STOP AND LOW SPEED ALARMS ON (B)(6) 2024 WHILE THE PATIENT WAS CONNECTED TO BATTERIES. THIS APPEARED TO BE THE RESULT OF A SHORT WITHIN THE DRIVELINE. THE PATIENT'S EQUIPMENT HAD A RELATIVELY SIGNIFICANT AMOUNT OF WEAR AND TEAR OVER THE YEARS, AND RESCUE TAPE HAD BEEN UTILIZED. THEY DID NOT LOSE OR GAIN ANY WEIGHT RECENTLY. X-RAYS WERE UNREMARKABLE. ON (B)(6) 2024 THE PATIENT'S DRIVELINE WAS REPAIRED APPROXIMATELY 3 INCHES FROM THE EXIT SITE. POST REPAIR, THE PATIENT WAS TETHERED TO AN UNGROUNDED CABLE WITHOUT ISSUE. AN UNSHIELDED CABLE WAS ORDERED FOR THE PATIENT. LOG FILES WERE SENT FOR REVIEW FOLLOWING THE REPAIR. THE LOG FILE DISPLAYED A FEW TRANSIENT DRIVELINE DISCONNECT / DRIVELINE FAULT ALARMS ASSOCIATED WITH THE DRIVELINE REPAIR ON (B)(6) 2024. 213 PULSATILITY (PI) EVENTS WERE CAPTURED IN THE EVENT LOG. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILE. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS EXPECTED. ADDITIONAL INFORMATION STATED THAT COMPUTED TOMOGRAPHY RESULTS SHOWED OUTFLOW GRAFT WAS PATENT WITHOUT EVIDENCE OF KINKING, OBSTRUCTION, OR THROMBOSIS. NO AORTIC ANEURYSM OR DISSECTION WAS NOTED. THERE WERE NO FURTHER PUMP STOPS. IT WAS FURTHER REPORTED THAT UPON INVESTIGATION OF THE DRIVELINE, THE FRACTURE APPEARED TO BE INTERNAL. THE PATIENT RECEIVED A HMII EXCHANGE ON (B)(6) 2024. THE ORIGINAL APICAL SEWING RING, INFLOW CONDUIT, AND OUTFLOW GRAFT REMAINED WITH THE PATIENT, THE PUMP WAS THE ONLY COMPONENT EXCHANGED IN THE PATIENT.
IT WAS LATER REPORTED THAT THE PATIENT REMAINED STABLE POST EXCHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2189491 | THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106015 | 00813024011224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention| H |