HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
Report
- Report Number
- 2916596-2021-03739
- Event Type
- Death
- Date Received
- July 26, 2021
- Date of Event
- May 27, 2021
- Report Date
- October 31, 2022
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P060040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR# 2916596-2022-02062 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON 26SEP2022 THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED SUSPECTED THROMBUS COULD NOT BE CONFIRMED THROUGH EVALUATION OF (B)(6). A REVIEW OF THE SUBMITTED LOG FILE CONFIRMED INTERMITTENT ELEVATED PUMP POWER EVENTS AND A LOW SPEED OPERATION EVENT; HOWEVER, A SPECIFIC CAUSE FOR THESE CHANGES IN PUMP PARAMETERS COULD NOT BE DETERMINED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED GASTROINTESTINAL (GI) BLEEDING AS WELL AS THE PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 5 DAYS OF DATA. MULTIPLE INTERMITTENT POWER ELEVATIONS WERE OBSERVED THROUGHOUT THE DURATION OF THE FILE. MANY OF THESE ELEVATIONS WERE ASSOCIATED WITH PI EVENTS, AND POWER APPEARED TO HAVE DECREASED TOWARDS BASELINE AFTER EACH ELEVATION. OF NOTE, THE DATA LOGGER WAS NOT ACTIVE. THE LOG FILE TERMINATES WITH A LOW SPEED OPERATION EVENT WHEN PUMP SPEED DECREASED TO 7770 RPM. EXCLUDING THIS EVENT, THE PUMP APPEARED TO HAVE FUNCTIONED AS INTENDED ABOVE THE LSL. A SPECIFIC CAUSE FOR THE OBSERVED CHANGES IN PUMP PARAMETERS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) INTACT, MEASURING APPROXIMATELY 37.5¿. THE SEALED INFLOW CONDUIT (INLET ELBOW, FLEX SECTION, AND INLET EXTENSION) WAS RETURNED DETACHED FROM THE PUMP INLET PORT. THE OUTLET ELBOW WAS RETURNED ATTACHED TO THE PUMP OUTLET PORT. THE OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND BEND RELIEF COLLAR WERE RETURNED SEPARATELY AND DETACHED FROM THE PUMP. EVALUATION OF THE SEALED INFLOW CONDUIT, OUTFLOW GRAFT, AND PUMP BODY UPON DISASSEMBLY REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. AN ELECTRICAL CONTINUITY TEST OF THE RETURNED DL WAS CONDUCTED, AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. NO WIRE-TO-WIRE OR WIRE-TO-SHIELD SHORTS WERE INDUCED DURING THIS TEST. THE JACKET, BIONATE, AND METAL-BRAIDED SHIELD WERE UNREMARKABLE UPON VISUAL INSPECTION. UPON DISASSEMBLY, MICROSCOPIC INSPECTION OF THE WIRES REVEALED NO BREACHES TO THE INSULATION. THE DL WAS SUBMERGED IN A SALINE BATH FOR HIGH POTENTIAL TESTING. THE TEST DID NOT REVEAL ANY CURRENT LEAKAGE THROUGH THE INSULATION OF ANY OF THE DL WIRES THAT WOULD HAVE RESULTED IN AN ELECTRICAL SHORT. THE PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. THE PUMP WAS REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. DATA RETRIEVED FROM TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS, AND THE DEVICE FUNCTIONED AS INTENDED. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D IS CURRENTLY AVAILABLE. SECTION 1 OF THE HEARTMATE II IFU, ¿INTRODUCTION¿, LISTS BLEEDING, DEVICE THROMBOSIS, AND DEATH AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS INCLUDING PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI). IN REFERENCE TO POWER, THIS SECTION EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. ALSO NOTED, IS THAT DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. HOWEVER, WHILE POWER IS DIRECTLY MEASURED BY THE SYSTEM CONTROLLER, THE REPORTED FLOW IS ESTIMATED, BASED ON POWER. SECTION 6, ¿PATIENT CARE AND MANAGEMENT, "UNDER ¿ANTICOAGULATION,¿ OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE. SECTION 7, "ALARMS AND TROUBLESHOOTING," OUTLINES ALL SYSTEM CONTROLLER ALARMS (INCLUDING LOW SPEED) AND HOW TO RESPOND TO THEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) 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.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), DOCUMENT IS CURRENTLY AVAILABLE. SECTION 5, ¿SURGICAL PROCEDURES¿, WARNS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
ON (B)(6) 2021, DUE TO EFFECTS OF TRANSIENT INCREASE IN BODY BLOOD PRESSURE DUE TO INSOMNIA AND ANGER DURING DEFECATION, SYMPTOMS OF RIGHT HEART FAILURE BECAME APPARENT AND OXYGENATION BECAME POOR. DUE TO POOR OXYGENATION, THE PATIENT WAS READMITTED ON THE SAME DAY. TREATMENT AT THE TIME OF READMISSION WAS OXYGEN ADMINISTRATION AND REST TREATMENT. ON (B)(6) 2021, THE PATIENT EXPERIENCED MASSIVE BLEEDING IN THE UPPER GASTROINTESTINAL TRACT. DUE TO BLEEDING, BLOOD TRANSFUSION WITH PACKED RED BLOOD CELLS WAS PERFORMED ON THE SAME DAY (LESS THAN 4 UNITS). NO DRUG TREATMENT. ANTICOAGULANT TREATMENT AT THE TIME OF EVENT OCCURRENCE WAS WARFARIN AND ASPIRIN. LABORATORY TEST VALUES MEASURED ON THE SAME DAY WERE INTERNATIONAL NORMALIZED RATIO (INR) 1.8, ACTIVATED PARTIAL THROMBOPLASTIN TIME 34 SECONDS, AND PLATELET COUNT OF 176,000 / L. THE CAUSE OF BLEEDING WAS BECAUSE THERE WAS A HISTORY OF LESIONS OR DISEASES AT THE BLEEDING SITE AND THE ONSET OF BLEEDING WAS PROMOTED, HYPERPLASTIC POLYPS FREQUENTLY OCCUR IN THE STOMACH AND WERE BEING FOLLOWED UP. ON (B)(6) 2020, THE PATIENT PASSED AWAY. AORTIC REGURGITATION CAUSED CIRCULATORY INSUFFICIENCY, LEADING TO MULTIPLE ORGAN FAILURE. THE PATIENT HAD UNDERGONE MULTIDISCIPLINARY TREATMENT TO RESTORE THEIR TOLERANCE, BUT DIED OF CARDIOGENIC SHOCK, WHICH WAS DIFFICULT TO RECOVER.
IT WAS REPORTED THAT THE DRIVELINE WAS NOT SUSPECTED TO BE DAMAGED BECAUSE IT WAS JUDGED TO BE A THROMBUS. GASTROINTESTINAL(GI) BLEEDING HAPPENED TO BE DISCOVERED IN A DIFFERENT GI AREA DURING AN EXAMINATION TO CONFIRM POLYP WITH GASTROSCOPE. THE CAUSE WAS NOT DETERMINED. THE PATIENT WAS REPEATEDLY HOSPITALIZED AND DISCHARGED DUE TO WORSENING HEART FAILURE SYMPTOMS. BLEEDING WAS NOT SEVERE. THE PATIENT WAS MONITORED DUE TO A TEMPORARY DECREASE IN ANTICOAGULANT MANAGEMENT. PATIENT EXPIRED ON (B)(6) 2021 DURING FOLLOW UP AT THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HEART FAILURE SYMPTOMS. THE PATIENT HAD BEEN STOPPED FROM ANTICOAGULANT DUE TO GASTROINTESTINAL BLEEDING. THE PATIENT'S PUMP POWER INCREASED. THE PATIENT'S HISTORY REVEALED A LOW SPEED OPERATION ALARM. A LOG FILE REVIEW SHOWED 111 PULSATILITY INDEX EVENTS IN APPROXIMATELY THE PREVIOUS 5 DAYS. THE PATIENT'S ORIGINAL HEART FAILURE GOT WORSE AND THE PATIENT PASSED AWAY ON (B)(6) 2021.
THIS EVENT TOOK PLACE AT (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HEART FAILURE SYMPTOMS. THE PATIENT HAD BEEN STOPPED FROM ANTICOAGULANT DUE TO GASTROINTESTINAL BLEEDING. THE PATIENT'S PUMP POWER INCREASED. THE PATIENT'S HISTORY REVEALED A LOW SPEED OPERATION ALARM AND THE SITE WAS CONCERNED ABOUT DRIVELINE DAMAGE. A LOG FILE REVIEW SHOWED 111 PULSATILITY INDEX EVENTS IN APPROXIMATELY THE PREVIOUS 5 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1122002 | HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 104911JPN | 6005028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R| D |