MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	T505U223
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Regurgitation (2259); Stenosis (2263)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that seven years and six months post implant of this bioprosthetic aortic valve, the patient is being evaluated for a transcatheter valve-in-valve procedure due to stenosis.No interventions have occurred.No adverse patient effects were reported.Approximately seven years and five months post implant of this 23mm bioprosthetic aortic valve, the patient developed increasing shortness of breath with exertion.Transesophageal echocardiogram (tee) revealed degenerative stenosis and mild insufficiency.The mean gradient was 45mmhg, with an estimated valve area of 1cm2.Ultimately, seven years and seven months post implant, a 26mm transcatheter aortic valve (tav) was attempted to be implanted valve-in-valve.During the implant procedure, the tav could not be positioned appropriately within the previous bioprosthetic valve, and the tav remained suspended in the ascending aorta during and after the procedure.The following day the patient underwent surgical resection of the attempted tav and previous bioprosthetic valve.A 25mm bioprosthetic valve of the same model as the "orginal" valve was successfully implanted.Intraoperatively there was "evidence of chronic pericarditis and a large shelf-like plaque in the distal ascending aorta and involving the origin of the innominate artery." examination of the original bioprosthetic valve revealed no obvious anatomical stenosis of the valve, but there was "much" fibrous tissue and scarring around the sewing and a "slight" amount of fibrous clot in two of the sinuses.Examination of the explanted tav revealed a "thin layer" of fibrous clot in each of the sinuses and fibrous clot on the lower and outsider portion of the cage as well.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8195744
• Report Number: 2025587-2018-03535
• Device Sequence Number: 244180
• Product Code: LWR
• UDI-Device Identifier: 00613994772725
• UDI-Public: 00613994772725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2014
• Device Model Number: T505U223
• Device Catalogue Number: T505U223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR