HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 2916596-2020-00897
- Event Type
- Injury
- Date Received
- February 18, 2020
- Date of Event
- February 4, 2020
- Report Date
- March 11, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Removal / Correction Number
- FA-Q124-HF-1
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION D4, G3 & H4: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSION: ALTHOUGH THE CAUSE OF THE REPORTED LOW FLOW ALARMS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE CENTER REPORTED THAT THE LOW FLOW EVENTS WERE CAUSED BY THE PARTIAL GRAFT OBSTRUCTION. THE REPORT OF A PARTIAL GRAFT OBSTRUCTION COULD NOT BE CONFIRMED AS NO IMAGES WERE SUBMITTED FOR REVIEW AND NO DEVICE WAS RETURNED FOR EVALUATION. THE ACCOUNT REPORTED THAT THE PATIENT COMPLAINED OF AN INCREASE IN FREQUENCY OF LOW FLOW ALARMS OVER THE PAST TWO WEEKS. THE PATIENT REPORTED THAT THE ALARMS OCCURRED WHEN THEY BENT TO THE LEFT SIDE. IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 FOR POSSIBLE OUTFLOW GRAFT TWISTING NOTED ON THEIR CT SCAN. ON (B)(6) 2020, THE PATIENT THEN UNDERWENT AN LHC/ANGIOGRAM WITH RESULTS SHOWING A PARTIAL OBSTRUCTIVE LESION IN THE PROXIMAL PORTION OF THE OUTFLOW GRAFT IMMEDIATELY ADJACENT TO THE PUMP AND AT THE BEND RELIEF EXIT POINT, WITH NO OVERT GRAFT TWISTING. THE SYSTEM CONTROLLER EVENT LOG FILES CAPTURED NINE LOW FLOW HAZARD ALARMS ON (B)(6) 2020, (B)(6) 2020, AND (B)(6) 2020 WHEN THE ESTIMATED FLOW DROPPED BELOW THE 2.5 LPM THRESHOLD. THERE WERE ALSO MULTIPLE CONTROLLER FAULT FLAGS FOR LOW FLOW CAPTURED THROUGHOUT THE LOG FILES; HOWEVER, THESE FAULT FLAGS WERE NOT ACTIVE LONG ENOUGH TO TRIGGER AN ALARM. ALSO OF NOTE, THE LVAD EVENT LOG FILES CAPTURED THE FLOW MEAN BELOW THE 2.5 LPM THRESHOLD FROM 08:53:16 TO 08:53:30 ON (B)(6) 2020, REACHING AS LOW AS 0.4 LPM. NO ADDITIONAL ATYPICAL ALARMS OR TRENDS IN PUMP PARAMETERS WERE CAPTURED. THE PUMP SPEED REMAINED AT OR ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOW FILES AND THE PUMP APPEARED TO FUNCTION AS INTENDED. IT WAS LATER REPORTED THAT THE PARTIAL GRAFT OBSTRUCTION WAS IDENTIFIED AS THE CAUSE OF THE LOW FLOW ALARMS. PER HEART FAILURE AND THE CT SURGERY TEAM, NO SURGICAL INTERVENTION WAS NEEDED AS THE LOW FLOWS WERE LIKELY POSITIONAL. THE PATIENT WAS UPGRADED ON THE UNOS WAITLIST TO STATUS 3 FOR DEVICE MALFUNCTION. AS OF (B)(6) 2020, THE PLAN OF CARE FOR THE PATIENT WAS TRANSPLANT AND SURVEILLANCE. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. THE INTRODUCTION OF THE HM3 IFU EXPLAINS THE PUMP PARAMETERS, INCLUDING FLOW. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THE HAZARD ALARMS SUB-SECTION OF THE HM3 IFU NOTES THAT ¿CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW, SUCH AS HYPERTENSION.¿ THE ALARMS AND TROUBLESHOOTING SECTION EXPLAINS ALL SYSTEM ALARMS, INCLUDING LOW FLOW ALARMS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS IFU CONTAINS INFORMATION REGARDING THE PREPARATION OF THE SEALED OUTFLOW GRAFT. THIS DOCUMENT 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. THE HM3 PATIENT HANDBOOK CAUTIONS THE USER TO CALL THEIR HOSPITAL CONTACT IF THEY THINK, 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
MANUFACTURER'S INVESTIGATION CONCLUSION: ALTHOUGH THE CAUSE OF THE REPORTED LOW FLOW ALARMS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE CENTER REPORTED THAT THE LOW FLOW EVENTS WERE CAUSED BY THE PARTIAL GRAFT OBSTRUCTION. THE REPORT OF A PARTIAL GRAFT OBSTRUCTION COULD NOT BE CONFIRMED AS NO IMAGES WERE SUBMITTED FOR REVIEW AND NO DEVICE WAS RETURNED FOR EVALUATION. THE ACCOUNT REPORTED THAT THE PATIENT COMPLAINED OF AN INCREASE IN FREQUENCY OF LOW FLOW ALARMS OVER THE PAST TWO WEEKS. THE PATIENT REPORTED THAT THE ALARMS OCCURRED WHEN THEY BENT TO THE LEFT SIDE. IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 FOR POSSIBLE OUTFLOW GRAFT TWISTING NOTED ON THEIR COMPUTED TOMOGRAPHY (CT) SCAN. ON (B)(6) 2020, THE PATIENT THEN UNDERWENT AN ANGIOGRAM WITH RESULTS SHOWING A PARTIAL OBSTRUCTIVE LESION IN THE PROXIMAL PORTION OF THE OUTFLOW GRAFT IMMEDIATELY ADJACENT TO THE PUMP AND AT THE BEND RELIEF EXIT POINT, WITH NO OVERT GRAFT TWISTING. THE SYSTEM CONTROLLER EVENT LOG FILES CAPTURED NINE LOW FLOW HAZARD ALARMS ON 04FEB2020, 05FEB2020, AND 08FEB2020 WHEN THE ESTIMATED FLOW DROPPED BELOW THE 2.5 LITERS PER MINUTE (LPM) THRESHOLD. THERE WERE ALSO MULTIPLE CONTROLLER FAULT FLAGS FOR LOW FLOW CAPTURED THROUGHOUT THE LOG FILES; HOWEVER, THESE FAULT FLAGS WERE NOT ACTIVE LONG ENOUGH TO TRIGGER AN ALARM. ALSO OF NOTE, THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) EVENT LOG FILES CAPTURED THE FLOW MEAN BELOW THE 2.5 LPM THRESHOLD ON 07FEB2020, REACHING AS LOW AS 0.4 LPM. NO ADDITIONAL ATYPICAL ALARMS OR TRENDS IN PUMP PARAMETERS WERE CAPTURED. THE LOG FILES SHOWED THAT THE PUMP APPEARED TO OPERATE AS INTENDED AT THE SET SPEED. IT WAS LATER REPORTED THAT THE PARTIAL GRAFT OBSTRUCTION WAS IDENTIFIED AS THE CAUSE OF THE LOW FLOW ALARMS. PER HEART FAILURE AND THE CT SURGERY TEAM, NO SURGICAL INTERVENTION WAS NEEDED AS THE LOW FLOWS WERE LIKELY POSITIONAL. THE PATIENT WAS UPGRADED ON THE UNOS WAITLIST TO STATUS 3 FOR DEVICE MALFUNCTION. THE ACCOUNT ALSO REPORTED THAT THE PATIENT WAS KNOWN TO HAVE RECURRENT VENTRICULAR TACHYCARDIA EPISODES AND WAS HOSPITALIZED TWICE WITH VOLUME OVERLOAD, DIZZINESS, AND PRE-SYNCOPAL EPISODES WITH INTERMITTENT LOW FLOW ALARMS OVER A 4-YEAR COURSE POST THEIR HEARTMATE 3 IMPLANTATION. ADDITIONALLY, THE PATIENT WAS ALSO KNOWN TO HAVE SUPRA-THERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) LEVELS. THE PATIENT REMAINED ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), UNTIL (B)(6) 2021, WHEN THE PATIENT WAS TRANSPLANTED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 27AUG2015 THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 1 ¿INTRODUCTION¿ OF THIS IFU PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING FLOW. SECTION 4 "SYSTEM MONITOR" PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM), AND ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 5 OF THE IFU, "SURGICAL PROCEDURES", CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS THAT PRIOR TO IMPLANTATION, THE BEND RELIEF SHOULD BE DISENGAGED FROM THE GRAFT FOR THE DE-AIRING PROCEDURE. SECTION 5 ALSO CONTAINS A SUB-SECTION ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP", INSTRUCTS THE USER TO VERIFY THAT THE OUTFLOW 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 5, UNDER "DE-AIRING THE PUMP", CAUTIONS THE USER: "DO NOT ROTATE/TWIST THE SEALED GRAFT. CHECK THE ALIGNMENT OF THE BLACK LINE ON THE GRAFT TO VERIFY THAT THE SEALED GRAFT IS NOT TWISTED OR KINKED." THIS SECTION ALSO EXPLAINS HOW TO ATTACH THE BEND RELIEF ONCE THE VENT NEEDLE HAS BEEN REMOVED FROM THE SEALED OUTFLOW GRAFT AND LEAKS HAVE BEEN RULED OUT. SECTION 5, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH." SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "ANTICOAGULATION") OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN (INCLUDING INR RANGE) FOR PATIENTS USING THE HEARTMATE 3 LVAS AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, IS ALSO CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. 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.
THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
IT WAS REPORTED THAT THE PATIENT HAD COMPLAINTS OF INCREASE IN FREQUENCY OF LOW FLOW ALARMS FOR THE PAST 2 WEEKS. PATIENT STATED ALARMS GO OFF WHEN THEY BEND TO THE LEFT SIDE. THEY ARE GETTING LABS AND UNDERGOING CT CHEST WITH CONTRAST TO EVALUATE PUMP FUNCTION. THE LOG FILE CAPTURED LOW FLOW EVENTS ON (B)(6) 2020. THE ESTIMATED FLOW APPEARS AT TIMES, TO BE BELOW THE ALARM THRESHOLD OF 2.5 LPM. PATIENT HAD CONTINUED TO EXPERIENCE LOW FLOW ALARMS. THE EVENT LOG CAPTURED SEVERAL LOW FLOW EVENTS ON (B)(6) 2020 BETWEEN 1050 AND 1138. THERE WERE TIMES IN THE LOG ON (B)(6) 2020 WHERE THE CALCULATED FLOW WAS AT THE 2.5 LPM THRESHOLD BUT WAS NOT SUSTAINED LONG ENOUGH FOR THE AUDIBLE ALARM. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE. PATIENT HAD A PARTIAL OUTFLOW GRAFT OBSTRUCTION. LOW FLOWS WERE FOUND TO BE POSITIONAL. PATIENT WAS UPGRADED ON THE UNOS WAITLIST TO STATUS 3 FOR DEVICE MALFUNCTION. PLAN WAS TRANSPLANT AND SURVEILLANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184461 | HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | 106524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention |