THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2024-06548
- Event Type
- Injury
- Date Received
- October 11, 2024
- Date of Event
- September 26, 2024
- Report Date
- June 25, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
CARDIOGENIC SHOCK REPORTED IN THE PREVIOUS REPORT IS CAPTURED UNDER MFR. REPORT # 2916596-2025-00454. B2 - OUTCOMES ATTRIBUTED TO ADVERSE - CORRECTION. H4 - DEVICE MANUFACTURE DATE - CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), CONFIRMED A THROMBUS FORMATION WITHIN THE INFLOW CANNULA WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED LOW FLOW ALARMS. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 6¿ FROM THE PUMP HEADER, WITH A MID-SECTION PORTION RETURNED MEASURING APPROXIMATELY 5¿. THE DISTAL END OF THE PUMP CABLE AND THE MODULAR CABLE WERE NOT RETURNED. THE OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE BEND RELIEF ENGAGED TO THE GRAFT HARDWARE. THE CUFF LOCK HAD BEEN DISENGAGED PRIOR TO THE PUMP¿S RETURN FOR EVALUATION. THE APICAL CUFF WAS NOT RETURNED. EVALUATION OF THE DISTAL END OF THE INFLOW CANNULA LUMEN REVEALED A TISSUE-LIKE THROMBUS FORMATION, WHICH APPEARED TO OCCLUDE THE MAJORITY OF THE BLOOD FLOW PATH. THE DEPOSITION HAD A SOFT STRUCTURE AND WAS LIGHTLY ADHERED TO THE INFLOW CANNULA LUMEN. THE SHAPE AND STRUCTURE OF THE THROMBUS FORMATION SUGGESTED THAT IT DEVELOPED WITHIN THE DISTAL END OF THE INFLOW CANNULA OVER AN UNDETERMINED AMOUNT OF TIME. ALTHOUGH THE DURATION OF TIME FOR WHICH THE DEPOSITION WAS PRESENT IN THE INFLOW CANNULA CANNOT BE CONCLUSIVELY DETERMINED, THE DEPOSITION HAD THE POTENTIAL TO CONTRIBUTE TO THE REPORTED LOW FLOW ALARMS CAPTURED IN THE SUBMITTED LOG FILES. THE INFLOW CANNULA DEPOSITION WAS SENT FOR HISTOPATHOLOGY ANALYSIS. PER THE ANALYSIS, THE LUMEN OF THE INFLOW CANNULA CONSISTED OF AN UNORGANIZED COAGULUM OF PROTEINACEOUS MATERIAL. THIS SUGGESTS THAT OVER TIME, A MULTILAYERING EFFECT OF PEELING PSEUDOINTIMA OCCURRED, OVERLAPPING DOWNSTREAM, RESULTING IN PROGRESSIVE THICKENING (STENOSIS) AT THIS JUNCTION. EVALUATION OF THE SUBMITTED CONTROLLER EVENT LOG FILES COLLECTIVELY CAPTURED EVENTS FROM 26SEP2024 THROUGH 28SEP2024. PERSISTENT LOW FLOW HAZARD ALARMS WERE CAPTURED THROUGHOUT THE FILES. THIS FINDING APPEARED CONSISTENT WITH THE REPORTED EVENTS, AND THE FINDING OF AN OCCLUSIVE THROMBUS WITHIN THE INFLOW CANNULA. DESPITE THE OBSERVED DECREASE IN FLOW, THE PUMP APPEARED TO HAVE FUNCTIONED AS INTENDED THROUGHOUT THE DURATION OF THE RETRIEVED DATA. MLP-032619 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 LVAS IFU, REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS DEVICE THROMBOSIS AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO ADDRESSES PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES" (UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿), INSTRUCTS THE USER TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. FURTHERMORE, SECTION 5, UNDER ¿IMPLANT PROCEDURES¿, WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ADDITIONALLY, THIS SECTION, UNDER ¿ANTICOAGULATION¿, PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. FURTHERMORE, SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOW FLOW ALARMS. THE PATIENT WAS NOT HYPERTENSIVE OR HYPOVOLEMIC. THE RIGHT VENTRICLE LOOKED "OKAY" ON ECHOCARDIOGRAM (ECHO). FLOW TRENDS ON INTERROGATION APPEARED TO BE DOWNWARD. URGENT LOG FILE REVIEW WAS REQUESTED WITH CONCERN FOR ANY INDICATION OF OUTFLOW GRAFT OBSTRUCTION (OGO) OR ANY OTHER ISSUE WITH PUMP FUNCTION. COMPUTED TOMOGRAPHY WAS TO BE PERFORMED TO RULE OUT OGO. THE EVENT LOG FILE CAPTURED PERSISTENT LOW FLOW EVENTS WITH THE ESTIMATED FLOW HOVERING AROUND THE 2.4 TO 2.5 LITER PER MINUTE (LPM) MARK. PULSATILITY INDEX (PI) VALUES WERE NON-VARIABLE AND SETTLED INTO THE 3 RANGE. THE PATTERNS WERE CONSISTENT WITH POTENTIAL OBSTRUCTION IN THE VENTRICULAR ASSIST DEVICE (VAD) CIRCUIT. ADDITIONAL LOG FILES WERE SUBMITTED BECAUSE THE PATIENT CONTINUED TO HAVE LOW FLOW ALARMS. A COMPREHENSIVE WORKUP WAS PERFORMED AND THE LOW FLOWS APPEARED TO BE UNRELATED TO AFTERLOAD, PRELOAD, RIGHT VENTRICLE FAILURE, OR OUTFLOW GRAFT KINK/POSITIONING. LACTATE DEHYDROGENASE (LDH) AND HEMOLYSIS LABS WERE NORMAL. THE DRIVELINE CONNECTIONS AND MODULAR CABLE CONNECTION WAS ALL INTACT. THE PATIENT SWITCHING POSITIONS MADE NO DIFFERENCE. THE ADDITIONAL LOG FILES WERE REVIEWED AND CONTAINED MOSTLY LOW FLOW EVENTS WITH AN OVERALL AVERAGE CALCULATED FLOW OF 2.4 LPMS. THE RECORDED DATA INDICATED THAT THESE EVENTS ARE NOT EQUIPMENT RELATED BUT MAY BE OF CLINICAL SIGNIFICANCE. THE OVERALL HISTORY OF THE EVENT LOG FILE WAS BRIEF DUE TO THE FREQUENTLY OCCURRING LOW FLOW EVENTS. THE TRENDED PERIODIC LOG FILE DATA WHICH IS CURRENTLY SET TO CAPTURE DATA EVERY 60 MINUTES APPEARS TO SHOW A SLOW, GRADUAL DOWNWARD TREND OVER THE PAST ~10.5 DAYS. THE PATIENT HAD CONTINUED TO EXPERIENCE LOW FLOWS ALARMS OF UNKNOWN ETIOLOGY DESPITE HEMODYNAMIC OPTIMIZATION. LOG FILES WERE SENT AS WELL AS COMPUTED TOMOGRAPHY (CT) AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE DONE WITHOUT ANY SIGNS OF OBSTRUCTION BASED ON DIAGNOSTIC TESTS. AN ECHO ALSO COMPLETED WHICH LOOKED OKAY. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND IT WAS PLANNED TO EXCHANGE THE PUMP. THE PUMP WAS EXCHANGED AND WAS RETURNED FOR EVALUATION. IT WAS REQUESTED THAT THE PUMP BE ANALYZED WITH THESE REQUESTS: FULL PATHOLOGY REPORT AND HISTOLOGICAL ANALYSIS OF THROMBI, LONGITUDINAL LOG FILE ANALYSIS TRENDS INCLUDING ROTOR NOISE, ROTOR TILT AND POSITION AND TO DETERMINE WHETHER OR NOT THIS WAS A SITUATION OF A MULTI-PHASIC THROMBI INGESTION VS DE-NOVO PUMP THROMBI INGESTION. OTHER POINTS NOTED WERE THE PATIENT REMOLDED THE LEFT VENTRICLE RAPIDLY (WITHIN 3 MONTHS) AND WENT FROM 7 CM TO 4.5 CM LEFT VENTRICLE. THE DOCTOR FELT THAT FROM MARCH TO NOW THE PATIENT HAD INGESTED MICRO EMBOLI CLOT THROUGH THE PUMP.
THE PATIENT WAS BACK IN HOUSE WITH CARDIOGENIC SHOCK. THE SITUATION WAS ESCALATING WITH THE PATIENT AND WAS IN HOUSE EXTREMELY SICK AND NOT DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342271 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 8465251 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Hospitalization| R| L |