MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

Report

Report Number: 2025587-2017-01558
Event Type: Injury
Date Received: September 7, 2017
Date of Event: October 3, 2016
Report Date: August 15, 2017
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: LWR
PMA / PMN Number: P990064
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CITATION: LOYALKA, P. TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A SAPIEN 3 COMMANDER 20 MM VALVES IN PATIENTS WITH DEGENERATED 19 MM BIOPROSTHETIC AORTIC VALVE. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. (2017); 89:1280¿1285. DOI 10.1002/CCD.26723. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE IMPLANT OF TRANSCATHETER BIOPROSTHETIC VALVES INTO DEGENERATED SURGICAL VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER DATABASE BETWEEN 2015 AND 2016. THE STUDY POPULATION INCLUDED 5 PATIENTS, ONE OF WHICH HAD BEEN PREVIOUSLY IMPLANTED WITH A MEDTRONIC 19MM MOSAIC. NINE YEARS POST IMPLANT, STENOSIS AND SUBSEQUENT INCREASED GRADIENTS ALONG WITH TRACE PARAVALVULAR LEAK (PVL) WERE NOTED. SUBSEQUENTLY, A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
628546	MOSAIC AORTIC BIOPROSTHETIC HEART VALVE	HEART-VALVE, NON-ALLOGRAFT TISSUE	LWR	MEDTRONIC HEART VALVES DIVISION	305_MOSAIC

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention