THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2024-52639
- Event Type
- Injury
- Date Received
- December 20, 2024
- Date of Event
- August 17, 2024
- Report Date
- May 12, 2026
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
SECTION H6: DUE TO SYSTEM LIMITATIONS THE FOLLOWING WAS NOT INCLUDED IN SECTION H6: HEALTH EFFECT - CLINICAL CODE: E1310 URINARY TRACT INFECTION. HEALTH EFFECT - CLINICAL CODE: E1901 BACTERIAL INFECTION. HEALTH EFFECT - CLINICAL CODE: E233801 PERIPHERAL EDEMA. HEALTH EFFECT - CLINICAL CODE: E1004 ASCITES. HEALTH EFFECT - CLINICAL CODE: E2343 HEMODYNAMIC INSTABILITY. HEALTH EFFECT - CLINICAL CODE: E0742 RESPIRATORY FAILURE. HEALTH EFFECT - CLINICAL CODE: E0306 SEPSIS. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
SECTION H6: DUE TO SYSTEM LIMITATIONS THE FOLLOWING WAS NOT INCLUDED IN SECTION H6: HEALTH EFFECT - CLINICAL CODE: E1310 URINARY TRACT INFECTION. HEALTH EFFECT - CLINICAL CODE: E1901 BACTERIAL INFECTION. HEALTH EFFECT - CLINICAL CODE: E233801 PERIPHERAL EDEMA. HEALTH EFFECT - CLINICAL CODE: E1004 ASCITES. HEALTH EFFECT - CLINICAL CODE: E2343 HEMODYNAMIC INSTABILITY. HEALTH EFFECT - CLINICAL CODE: E0742 RESPIRATORY FAILURE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
IT WAS LATER REPORTED THAT ALTHOUGH THERE WAS A LOT OF SUBCUTANEOUS BLEEDING ON (B)(6) 2024, THE SITE BELIEVED IT WAS NOT MASSIVE BLEEDING, BUT RATHER A DROP IN BLOOD PRESSURE RELATED TO INFECTION OR SEPSIS.
THE PATIENT HAD SOME HISTORY OF RIGHT HEART FAILURE PRIOR TO IMPLANT WITH THE LEFT VENTRICULAR ASSIST DEVICE (LVAD), HOWEVER THE SITE STATED THAT IT WAS POSSIBLE THE RIGHT HEART FAILURE WORSENED AS A RESULT OF THE LVAD IMPLANT. THEY WERE TREATED WITH WATER REMOVAL BY CONTINUOUS HEMODIAFILTRATION (CHDF), WHICH REDUCED THE LOAD ON THE RIGHT HEART. THEY UNDERWENT CHDF WITHDRAWAL AND DOSING PULMONARY VASODILATORS. THE PATIENT BECAME STABLE AND WAS TRANSFERRED ON (B)(6) 2024.
IT WAS REPORTED THE PATIENT DEVELOPED RIGHT HEART FAILURE ON (B)(6) 2024. THEIR CENTRAL INTRAVENOUS PRESSURE (CVP) WAS OVER 18 MMHG AND CARDIAC INDEX (CI) WAS LESS THAN 2.0 L/MIN. THE PATIENT ALSO HAD ASCITES AND PERIPHERAL EDEMA. THE RIGHT HEART FAILURE WAS THOUGHT TO BE DUE TO PATHOGENESIS. THE PATIENT EXPERIENCED RESPIRATORY FAILURE SHORTLY AFTER IMPLANT ON (B)(6) 2024. THE PATIENT WAS INTUBATED. THE RESPIRATORY MUSCLES WERE DUE TO PATHOGENS AND FATIGUE MAY HAVE BEEN RESPONSIBLE. A TRACHEOSTOMY WAS PERFORMED. IT WAS REPORTED THE PATIENT DEVELOPED LIVER DYSFUNCTION ON (B)(6) 2024. THEIR TOTAL BILIRUBIN VALUE WAS 1.2 MG/DL, ASPARTATE AMINOTRANSFERASE (AST) VALUE WAS 1596 U/L, AND ALANINE AMINOTRANSFERASE (ALT) VALUE WAS 634 U/L. THE CAUSAL RELATIONSHIP TO THE DEVICE WAS CONSIDERED LOW BUT COULD NOT BE DENIED. THE HEPATIC DYSFUNCTION WAS THOUGHT TO HAVE BEEN DUE TO HEMORRHAGIC SHOCK WHILE TAKING WARFARIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MASSIVE BLEED ON THEIR RIGHT THIGH ON (B)(6) 2024 WHILE IN THE HOSPITAL. THEY RECEIVED A BLOOD TRANSFUSION WITH RED CELL CONCENTRATE (RCC) ON (B)(6) 2024. THERE WAS APPROXIMATELY 40 ML/KG RCC OR MORE TRANSFUSED OVER A 24 HOUR PERIOD. THE PROTHROMBIN TIMES (INTERNATIONAL NORMALIZED RATIO) WAS 1.1 IU, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) WAS 60 SECONDS, AND PLATELET COUNT (PLT) WAS 8.4 ×104/L. THEIR PATIENT WAS GIVEN HEPARIN AND ASPIRIN AS ANTICOAGULANT THERAPY AT THE TIME OF THE EVENT. THE CAUSE OF THE BLEEDING WAS THOUGHT TO BE DUE TO COMPLICATIONS WITH MEDICAL MANAGEMENT AS THE PATIENT WAS ON WARFARIN. THE CAUSAL RELATIONSHIP WITH THE DEVICE WAS CONSIDERED LOW BUT COULD NOT BE DENIED. IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT DEVELOPED A BACTERIAL, PULMONARY INFECTION, WHICH WAS SUSPECTED TO BE PNEUMONIA DUE TO PROLONGED VENTILATOR MANAGEMENT. THEY WERE TREATED WITH DRUG THERAPY ONLY. THE CAUSAL RELATIONSHIP WITH THE DEVICE WAS THOUGHT TO BE NOT RELATED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MASSIVE UPPER GASTROINTESTINAL BLEED ON (B)(6) 2024. THEY RECEIVED ABOUT 40 ML/KG OR MORE OF RED CELL CONCENTRATE (RCC) BLOOD TRANSFUSION ON (B)(6) 2024. THE PATIENT'S PROTHROMBIN TIMES (INTERNATIONAL NORMALIZED RATIO) WAS 2.0 IU, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) WAS 43 SECONDS, AND THEIR PLATELET COUNT WAS 9.6 ×104/L. THE PATIENT WAS THEN GIVEN WARFARIN AND ASPIRIN FOR ANTICOAGULATION THERAPY. THE CAUSAL RELATIONSHIP TO THE DEVICE WAS CONSIDERED LOW BUT COULD NOT BE DENIED. THE GASTROINTESTINAL BLEEDING WAS THOUGHT TO HAVE BEEN DUE TO TAKING WARFARIN. IT WAS REPORTED THE PATIENT'S LOG FILES WERE SUBMITTED FOR ANALYSIS PRIOR TO TRANSFER TO A DIFFERENT HOSPITAL. FOLLOWING REVIEW OF THE SUBMITTED LOG FILES, IT APPEARED THERE WERE LOW FLOW EVENTS ON 25OCT2024 AND 01NOV2024. THERE DID NOT APPEAR TO BE ANY TYPE OF EQUIPMENT ISSUES CAUSING THE EVENTS. IT WAS REPORTED THE PATIENT DEVELOPED A BACTERIAL, URINARY TRACT INFECTION (UTI) ON (B)(6) 2024. THE INFECTION WAS TREATED WITH DRUG THERAPY ONLY. THE SITE SUSPECTED THE UTI MAY HAVE BEEN ASSOCIATED WITH INDWELLING URETHRAL CATHETERIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614495 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 10227503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |