HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
Report
- Report Number
- 2916596-2019-00279
- Event Type
- Injury
- Date Received
- January 18, 2019
- Date of Event
- December 31, 2018
- Report Date
- March 10, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013266
- PMA / PMN Number
- P160054
- Removal / Correction Number
- FA-Q124-HF-1
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTIONS B3, G3: CORRECTED DATA. SECTION B5: ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.
MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED OUTFLOW GRAFT OBSTRUCTION AND BLEEDING COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE PROVIDED FOR REVIEW. THE ACCOUNT COMMUNICATED THAT THE LOW FLOW ALARMS RESOLVED AFTER AN OUTFLOW GRAFT REVISION. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. THE IFU EXPLAINS THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND NOTES THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS IFU ALSO DESCRIBES ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS IFU CONTAINS INFORMATION ON PREPARING THE SEALED OUTFLOW GRAFT AND CAUTIONS THE USER NOT TO ROTATE/TWIST THE GRAFT. THE IFU 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO LOG FILES WERE SUBMITTED FOR REVIEW AND NO PRODUCT WAS RETURNED FOR EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4) AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HM3 LVAS IFU EXPLAINS THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND NOTES THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS IFU ALSO DESCRIBES ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE IFU ALSO CONTAINS INFORMATION REGARDING THE PREPARATION OF THE SEALED OUTFLOW GRAFT. IT 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. IT ALSO EXPLAINS THAT WHEN DE-AIRING IS COMPLETED, SLIDE THE BEND RELIEF OVER THE METAL FITTING OF THE SEALED OUTFLOW GRAFT TOWARD THE LOCKING SCREW RING. THIS IFU ALSO WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED OUTFLOW GRAFT OBSTRUCTION AND BLEEDING COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE PROVIDED FOR REVIEW; HOWEVER, THE ACCOUNT COMMUNICATED THAT THE LOW FLOW ALARMS RESOLVED AFTER AN OUTFLOW GRAFT REVISION. THE PATIENT REPORTED FEELING LIGHTHEADED WITH LOW BLOOD PRESSURE. THE PATIENT WAS ADMITTED ON (B)(6) 2018 WITH LOW FLOW ALARMS. THE PATIENT WAS FOUND TO HAVE AN OUTFLOW GRAFT OBSTRUCTION ON COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR AN OUTFLOW GRAFT REVISION ON (B)(6) 2019. ACCORDING TO THE ACCOUNT, THERE WAS A BUILDUP OF FATTY TISSUE BETWEEN THE OUTFLOW GRAFT (OFG) AND A GORTEX BEND RELIEF PLACED ABOVE THE HEARTMATE 3 OFG BEND RELIEF. THE SURGEON CUT OPEN THE GORTEX BEND RELIEF, REMOVED THE FATTY TISSUE, AND DRAINED THE FLUID TO RELIEVE PRESSURE. THERE WAS NO OFG TWISTING NOTED. A POST-OP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED SUCCESS. THE PATIENT STARTED BLEEDING ON (B)(6) 2019, 2 DAYS POST-OP FROM THE OUTFLOW GRAFT REVISION AND DEVELOPED A RIGHT HEMOTHORAX. THE PATIENT REQUIRED READMISSION TO THE INTENSIVE CARE UNIT (ICU). CHEST TUBES WERE PLACED, AND THE PATIENT WAS RETURNED TO THE OR FOR THE EVACUATION OF THE HEMOTHORAX. THE PATIENT ULTIMATELY RECOVERED AND WAS DISCHARGED HOME ON (B)(6) 2019. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). 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 25NOV2015 THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 IN THE EVENT THAT THERE IS A RISK OF BLEEDING. SECTION 1 OF THE IFU ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THIS IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 7, "ALARMS AND TROUBLESHOOTING", DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD ALARM, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. 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 1 LISTS THE OUTFLOW GRAFT CLIP AS A REQUIRED COMPONENT FOR IMPLANT. SECTION 5 FURTHER INSTRUCTS THE USER TO ¿ATTACH THE OUTFLOW GRAFT CLIP TO PREVENT POST-OPERATIVE OUTFLOW GRAFT TWISTING¿ AND WARNS THAT FAILURE TO INSTALL THE OUTFLOW GRAFT CLIP SO THAT IT IS FLUSH WITH THE BEND RELIEF CAN ALLOW GRAFT TWISTING OR ABRASION WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS BLEEDING, GRAFT OCCLUSION, THROMBOSIS, AND/OR DEATH. 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 PATIENT BECAME SYMPTOMATIC WITH HEART FAILURE SYMPTOMS AND WAS ADMITTED ON (B)(6) 2018 FOR EVALUATION OF LOW FLOW ALARMS. THE PATIENT HAD LIGHTHEADEDNESS AND LOW BLOOD PRESSURE WITH A MAP OF 46. THE PATIENT WAS FOUND TO HAVE AN OUTFLOW GRAFT (OFG) OBSTRUCTION ON A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE PATIENT WENT TO THE OPERATING ROOM ON (B)(6) 2019 FOR OFG REVISION/REPAIR. THE PATIENT WAS NOTED TO HAVE A BUILDUP OF FATTY TISSUE BETWEEN THE OFG AND A GORTEX BEND RELIEF WHICH HAD BEEN PLACED ABOVE THE HEARTMATE 3 OFG BEND RELIEF AT THE TIME OF IMPLANT. THE SURGEON CUT OPEN THE GORTEX BEND RELIEF AND REMOVED THE FATTY TISSUE AND DRAINED THE FLUID TO RELIEVE PRESSURE. THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) FLOWS RETURNED TO NORMAL. NO OFG TWISTING WAS NOTED. A POSTOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED SUCCESS. THE PATIENT RECOVERED WELL AND WAS DISCHARGED HOME ON (B)(6) 2019. ON (B)(6) 2019, 2 DAYS AFTER THE OFG REVISION, THE PATIENT DEVELOPED A RIGHT HEMOTHORAX. THE PATIENT WAS READMITTED TO THE INTENSIVE CARE UNIT (ICU). CHEST TUBES WERE PLACED. BLOOD TRANSFUSION WAS PERFORMED TO ADDRESS BLEEDING. THE PATIENT RETURNED TO THE OPERATING ROOM FOR EVACUATION OF HEMOTHORAX.
APPROXIMATE AGE OF DEVICE- 2 YEARS, 10 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO INTERMITTENT OR CONTINUOUS LOW FLOW ALARMS. CT ANGIOGRAM WAS PERFORMED AND SHOWED A KINK NEAR THE OUTFLOW GRAFT (OFG) AORTIC ANASTOMOSIS. THE CLINICIAN TEAM DOES NOT SUSPECT OFG TWIST, BUT RATHER CAUSED BY GORTEX GRAFT AROUND BEND RELIEF. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REVISE OFG ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54854 | HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | 106524 | 147083 | 00813024013266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Hospitalization| R |