HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 2916596-2019-02339
- Event Type
- Death
- Date Received
- May 28, 2019
- Date of Event
- May 9, 2019
- Report Date
- August 13, 2019
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PATIENT CODE UPDATED WITH ADDITIONAL INFORMATION AND PREVIOUSLY OMITTED INFORMATION.
MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT¿S INFECTION AND SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. FURTHERMORE, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. IT WAS COMMUNICATED THAT HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), OPERATED AS EXPECTED AND WOULD NOT BE RETURNED FOR EVALUATION. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING, INFECTION (LOCALIZED, DRIVELINE AND PUMP POCKET), SEPSIS, RENAL DYSFUNCTION, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION ARE PROVIDED IN SEVERAL SECTIONS OF THIS DOCUMENT. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PHYSICIANS HAVE NOT BEEN ABLE TO IDENTIFY THE SOURCE OF THE GASTROINTESTINAL BLEEDING. ON (B)(6) 2019, A COMPUTER TOMOGRAPHY OF THE CHEST, ABDOMEN AND PELVIS WAS CONDUCTED AND REVEALED NO ABNORMALITIES. A RECENT IRON PANEL WAS CONDUCTED AND WAS REMARKABLE FOR ANEMIA OF CHRONIC DISEASE (ACD). PATIENT DECIDED TO DISCHARGE HOME WITH HOSPICE SERVICE, HOWEVER, DUE TO THE IV ANTIBIOTICS, THE PATIENT WAS NOT APPROVED FOR HOSPICE SERVICE AT THIS TIME. NO FURTHER INFORMATION PROVIDED.
IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2019. THE PATIENT EXPIRED DUE PATIENT CONDITION, AND THERE WERE NO DEVICE ISSUES ASSOCIATED WITH THE OUTCOME. THE DEVICE OPERATED AS EXPECTED AND WILL NOT BE RETURNED FOR EVALUATION. PATIENT CAUSE OF DEATH WAS CONCLUDED TO BE BECAUSE OF INFECTION AND FAILURE TO THRIVE. NO FURTHER INFORMATION PROVIDED.
IT WAS REPORTED THAT THE CULTURE TAKEN ON (B)(6) 2019 HAD POSITIVE RESULTS FOR KLEBSIELLA PNEUMONIA. ON (B)(6) 2019 PATIENTS HEMOGLOBIN LEVELS DROPPED TO 7.8 & PATIENT WAS HAVING MELANOTIC STOOLS, DUE TO RECURRENT GASTROINTESTINAL BLEEDING. AS A RESULT, PATIENT WAS GIVEN 2 UNITS OF BLOOD. NO FURTHER INFORMATION PROVIDED.
ADDITIONAL INFORMATION: PATIENT'S BASELINE CREATININE WAS 1.20 MG/DL. ACUTE INTERSTITIAL NEPHRITIS (AIN) AND SEPSIS RELATED TO ACUTE KIDNEY INJURY (AKI) WERE ALSO AMONG THE DIFFERENTIAL DIAGNOSIS. DURING ADMISSION ON (B)(6) 2019 THE PATIENT'S CREATININE IMPROVED WITH LIGHT INTRAVENOUS FLUIDS. PATIENT'S DIURETICS WERE HELD AND NEPHROLOGY SUGGESTED GENTLE HYDRATION OF 50-75 CC/HOUR AND FOLLOW URINE OUTPUT. ON THE DAY OF DISCHARGE ((B)(6) 2019) THE PATIENT'S CREATININE WAS 1.65. WARFARIN WAS HELD DUE TO GASTROINTESTINAL BLEEDING. COMPUTED TOMOGRAPHY OF CHEST, ABDOMEN, AND PELVIS SHOWED NO EVIDENCE OF AN INFECTIOUS SOURCE ALTHOUGH IT WAS LIMITED DUE TO NO CONTRAST. FOLLOWING BLOOD TRANSFUSION THE PATIENT DID NOT HAVE ANY FURTHER EPISODES OF MELANOTIC STOOLS AND WAS CONTINUED ON SUBCUTANEOUS INJECTIONS OF OCTREOTIDE.
IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED ON (B)(6) 2019 WITH HEMOGLOBIN OF 9.5.
APPROXIMATE AGE OF DEVICE - 1 YEAR & 7 MONTHS. 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 SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING (B)(6) TRIAL. 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.
THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR FATIGUE, GENERALIZED MALAISE & ACUTE KIDNEY INJURY ON (B)(6) 2019 WHERE HE WAS FOUND TO HAVE ELEVATED WHITE BLOOD CELL(WBC) COUNT AND LOW RESISTANCE TRANSFER FACTOR (RTF). UPON ARRIVAL, PATIENTS CREATININE WAS 3.48 MILLIGRAMS/DECILITER. PER NEPHROLOGY CONSULT, IT COULD BE RELATED TO LOW RENAL PERFUSION DUE TO LOW BLOOD PRESSURE ADDED TO LOW ORAL INTAKE OVER THE PAST FEW DAYS. PATIENT ALSO HAD AN ULTRA SOUND FOR KIDNEY, WHICH RELAYED NORMAL RESULTS. PATIENT WAS STARTED ON LEVOPHED 0.05 MCG/KG/MIN AFTER HE WAS GIVEN 3 L OF IV. BLOOD & FUNGAL CULTURE WERE TAKEN ON (B)(6) 2019 AND WERE POSITIVE FOR KLEBSIELLA PNEUMONIA. PATIENT WAS STARTED ON VANCOMYCIN AND CEFEPIME. PATIENT WAS THEN DISCHARGED ON (B)(6) 2019. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440819 | HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM | LEFT VENTRICULAR ASSIST SYSTEM | DSQ | THORATEC CORPORATION | 106524 | 5936874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death| H| R |