FDA Adverse Event Injury Summary report: N

MOSAIC PORCINE HEART VALVE

MDR report key: 10455390 · Received August 26, 2020

Report

Report Number: 2025587-2020-02679
Event Type: Injury
Date Received: August 26, 2020
Date of Event: January 1, 2010
Report Date: August 26, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: LWR
PMA / PMN Number: P990064
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: FR99525, SERIAL/LOT #: (B)(4), UDI#: (B)(4), PMA/510(K): P970031. EVENT DATE AND EXPLANT DATES ARE YEAR VALID ONLY. PRODUCT ANALYSIS: NO PRODUCTS WERE RETURNED. ONE OF THE PRODUCTS REMAINS IN THE PATIENT. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 4 YEARS AND 9 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE AND BIOPROSTHETIC FULL AORTIC ROOT VALVE, BOTH VALVES WERE REPLACED. THE MITRAL VALVE WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. THE AORTIC VALVE REMAINED IMPLANTED, BUT A NON-MEDTRONIC MECHANICAL VALVED CONDUIT WAS IMPLANTED INSIDE THE AORTIC ROOT PROSTHESIS. IT WAS REPORTED THAT AT THE TIME OF EXPLANT THE PATIENT HAD "RIPPING OF THE PORCINE VALVE". BOTH MEDTRONIC VALVES (MITRAL AND AORTIC) ARE PORCINE VALVES. AS SUCH, IT IS UNCLEAR WHICH VALVE, OR IF BOTH VALVES, "RIPPED". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
918545	MOSAIC PORCINE HEART VALVE	HEART-VALVE, NON-ALLOGRAFT TISSUE	LWR	MEDTRONIC HEART VALVES DIVISION	310F31

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Required Intervention