FDA Adverse Event Injury Summary report: N

HEARTMATE 3 LVAS IMPLANT KIT

MDR report key: 12562414 · Received October 1, 2021

Report

Report Number: 2916596-2021-05202
Event Type: Injury
Date Received: October 1, 2021
Date of Event: August 7, 2020
Report Date: December 14, 2021
Manufacturer: THORATEC CORPORATION
Product Code: DSQ
PMA / PMN Number: P160054
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURER'S INVESTIGATION CONCLUSION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-010891 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. ALTHOUGH THERE WERE NO DEVICE-RELATED ISSUES REPORT, THE IFU LISTS ALL ADVERSE EVENTS THAT ARE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. NO DEVICE-RELATED ISSUES WERE REPORTED IN ASSOCIATION WITH THE EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

Description of Event or Problem · 0

THE PATIENT WAS BRIDGE TO TRANSPLANT, AND THE TRANSPLANT OCCURRED AS A PART OF PLANNED ROUTINE CARE. NO ISSUES WITH THE DEVICE OCCURRED.

Additional Manufacturer Narrative · 1

NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS BRIDGE-TO-TRANSPLANT AND UNDERWENT A HEART TRANSPLANT. WHETHER THE TRANSPLANT WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1456851	HEARTMATE 3 LVAS IMPLANT KIT	VENTRICULAR (ASSISST) BYPASS	DSQ	THORATEC CORPORATION	106524INT	6388313

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Hospitalization