THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2024-02310
- Event Type
- Injury
- Date Received
- April 29, 2024
- Date of Event
- April 10, 2024
- Report Date
- September 11, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
SECTION D1: CORRECTED. SECTION D4, CATALOG NUMBER, PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
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 DETERMINED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILES REVEALED NO NOTABLE EVENTS OR ALARMS AND CAPTURED THE PUMP FUNCTIONING AS INTENDED AT THE SET SPEED. REVIEW OF THE PATIENT¿S HISTORY REVEALED NO PRIOR REPORTED COMPLAINTS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RENAL DYSFUNCTION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 COMPLETED.
IT WAS FURTHER REPORTED THAT THE PATIENT HAD A HISTORY OF CHRONIC KIDNEY DISEASE (CKD) WITH BASELINE CREATININE AROUND 1.5 TO 1.7 AT THE TIME OF IMPLANT IN 2019. THEIR BASELINE CREATININE WAS AROUND 2.0 TO 2.3 AT THIS TIME. A COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE TO RULE OUT OBSTRUCTION. IT WAS NEGATIVE. VENTRICULOGRAPHY (LV GRAM) WAS ALSO PERFORMED AND DID NOT SHOW ANY OBVIOUS EVIDENCE OF OUTFLOW OR INFLOW ISSUES. THE PATIENT REPORTEDLY HAD MULTIPLE BLOCKAGES THAT WERE STENTED. THE PATIENT WAS DOING MUCH BETTER AFTER.
IT WAS REPORTED THAT PATIENT PRESENTED TO THE HOSPITAL WITH ONGOING SHORTNESS OF BREATH AND CHEST PAIN. A RIGHT HEART CATHETERIZATION (RHC) WAS PERFORMED, AS WELL AS AN ECHOCARDIOGRAM RAMP STUDY THAT REVEALED DECREASED CARDIAC OUTPUT AND CARDIAC INDEX. THERE WERE NO CHANGES IN HEMODYNAMICS WITH AN INCREASE IN SPEED AND NO INCREASE IN FLOW THROUGH THE PUMP. IT WAS UNKNOWN IF THIS WAS DEVICE RELATED. THE PATIENT WAS PLACED ON MILRINONE AND DIURETICS. THE PLAN WAS TO GET COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) TO LOOK FOR OUTFLOW GRAFT OBSTRUCTION (OGO) BUT THE SITE WAS UNABLE TO AT THE TIME DUE TO POOR RENAL FUNCTION.
IT WAS FURTHER REPORTED THAT BLOCKAGES WERE A 75% STENOSIS OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND 65% IN-STENT RESTENOSIS (ISR) OF THE MID LAD STATUS POST PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DRUG-ELUTING STENTS (DES) ONE TIME POST DILATED AGGRESSIVELY WITH A 3.75 MM NON-COMPLIANT (NC) BALLOON TO 26 ATMOSPHERES (ATM) IN THE PROXIMAL TO MID PART OF THE STENT AND 2.5 -3.0 MM NC BALLOON AT THE DISTAL SEGMENT WITH NO RESIDUAL STENOSIS. THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) GRADE 3 FLOW AND NO RESIDUAL STENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021581 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 7271229 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Hospitalization| R |