THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2024-52919
- Event Type
- Death
- Date Received
- January 8, 2025
- Date of Event
- December 15, 2024
- Report Date
- February 17, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED (INCLUDING PRODUCTION ORDERS AS WELL AS RECORDS IN THE MANUFACTURING EXECUTION SYSTEM) AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS SEPSIS, DRIVELINE INFECTION, LOCALIZED INFECTION, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION INCLUDES INFORMATION FOR CARING FOR THE DRIVELINE EXIT SITE AS WELL AS INFORMATION REGARDING HOW TO PREVENT AND CONTROL INFECTION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, CONTAINS SEVERAL SECTIONS WITH INFORMATION ABOUT HOW TO PREVENT AND CONTROL INFECTION AS WELL AS INFORMATION FOR CARING FOR THE DRIVELINE EXIT SITE. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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.
IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO SEPSIS. IT WAS STATED THAT THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED AND WAS DUE TO SEPSIS. AN AUTOPSY WAS NOT PERFORMED AND WOULD NOT BE PROVIDED. THE PUMP WAS NOT EXPLANTED AND WOULD NOT BE RETURNED.
THE CAUSE OF DEATH WAS NOT CONFORMED TO BE DUE TO SEPSIS FROM URINARY INFECTION. THE CAUSE OF THE PATIENT'S ARREST AND HEMODYNAMIC COMPROMISE IN THE SETTING OF LEUKOCYTOSIS AND PURULENT DRAINAGE, FUNCTIONING VENTRICULAR ASSIST DEVICE (VAD), COLLAPSIBLE INFERIOR VENA CAVA (IVC) AND RETURN OF IMPROVED BLOOD PRESSURE AND HEART RATE WITH ADMINISTRATION OF EPINEPHRINE BOLUSES WAS NOT CLEAR. THE PATIENT MOST LIKELY EXPERIENCED DISTRIBUTIVE SHOCK. THE ONSET OF THE INFECTION WAS UNKNOWN. BLOOD CULTURES WERE ORDERED BUT THE RESULTS WERE NOT DOCUMENTED. THE PATIENT PASSED AWAY IN THE EMERGENCY DEPARTMENT BEFORE THE INFECTION WAS TREATED.
IT WAS NOTED THAT THE PATIENT HAD MOVED FROM THEIR ORIGINAL IMPLANTATION SITE TO A NEW SITE. ONE WEEK AFTER MOVING THE PATIENT PASSED AWAY FROM SEPSIS THAT WAS MOST PROBABLY FROM URINARY INFECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1536223 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | L00000264 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Death |