FDA Adverse Event Death Summary report: N

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

MDR report key: 9735256 · Received February 20, 2020

Report

Report Number: 2025587-2020-00535
Event Type: Death
Date Received: February 20, 2020
Date of Event: January 7, 2020
Report Date: February 20, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: DYE
UDI-DI: 00643169594968
PMA / PMN Number: P990064
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 305U229, SERIAL/LOT #: (B)(4), PMA #: P990064, UBD: 15-JAN-2024, UDI#: (B)(4). MULTIPLE ATTEMPTS TO OBTAIN INFORMATION FROM THE HEALTHCARE PROFESSIONAL HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL. PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. 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 DURING AN AORTIC VALVE REPLACEMENT, A 25MM BIOPROSTHETIC VALVE AND A 29MM BIOPROSTHETIC VALVE OF THE SAME MODEL WERE BOTH REPORTED TO BE USED DURING THE PROCEDURE. IT IS UNKNOWN WHICH DEVICE WAS ATTEMPTED TO BE IMPLANTED FIRST OR WHICH DEVICE WAS ULTIMATELY IMPLANTED. ONE DAY POST IMPLANT, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT RECEIVED. IT WAS REPORTED THAT "THE PATIENT WAS EXTREMELY SICK AND HIS DEATH DID NOT HAVE TO DO WITH THE VALVES" AND THAT THE PROCEDURE WAS "A LAST ATTEMPT TO HELP THE PATIENT". IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
198669	MOSAIC AORTIC BIOPROSTHETIC HEART VALVE	HEART-VALVE, REPLACEMENT	DYE	MEDTRONIC HEART VALVES DIVISION	305U225		00643169594968

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Death