FDA Adverse Event Injury Summary report: N

HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

MDR report key: 1004038 · Received February 22, 2008

Report

Report Number: 2025587-2008-00010
Event Type: Injury
Date Received: February 22, 2008
Date of Event: January 22, 2008
Report Date: January 23, 2008
Manufacturer: MEDTRONIC HEART VALVES, INC
Product Code: LWR
PMA / PMN Number: P980043
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION - RESULTS- DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSIONS- EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED AS THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. ANALYSIS: TO DATE, THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. RETURN OF THE PRODUCT, HOWEVER, IS ANTICIPATED. WITHOUT PRODUCT RETURN, ANALYSIS IS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWS THAT THIS PRODUCT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: NO DEFINITIVE CONCLUSIONS CAN BE DRAWN AT THIS TIME AS THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED A PARAVALVULAR LEAK AND TISSUE OVERGROWTH, AS WELL AS A PERFORATION IN THE RIGHT AND NONCORONARY CUSP. THE DEVICE WAS EXPLANTED, AND CALCIFICATION/CUSPAL TEARS RESULTING IN STRUCTURAL DYSFUNCTION WERE REPORTED. THE DEVICE WAS REPLACED WITH A MECHANICAL VALVE, WITHOUT REPORTED COMPLICATION. THE VALVE HAD BEEN IN SERVICE FOR APPROX 2 YRS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE		LWR	MEDTRONIC HEART VALVES, INC	T505	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Hospitalization\| R