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

Model Number	T505U
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); No Information (3190)
Date of Event	08/16/2017
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.The dhr review was performed on the device; there were no correlations / issues identified regarding manufacturing.There were no n on-conformances (ncmrs) identified and no deviations noted against the device could impact this event.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.
Event or Problem Description
Medtronic received information that 11 months post implant of this aortic bioprosthetic valve, the patient was being considered for valve replacement.Subsequently 23 days later, the patient underwent an attempted replacement procedure with a transcatheter valve (valve-in-valve).The attempted valve-in-valve implant was unsuccessful due to patient anatomy and this device remains implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received that 11 months post implant of this aortic bioprosthetic valve, an echocardiogram showed aortic insufficiency and elevated gradients.Subsequently a non-medtronic valve was implanted valve-in-valve.No additional adverse patient effects were reported.Corrected the aware date.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6958809
• Report Number: 2025587-2017-01870
• Device Sequence Number: 19003450
• Product Code: LWR
• UDI-Device Identifier: 00643169534100
• UDI-Public: 00643169534100
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 04/18/2019
• Device Model Number: T505U
• Device Catalogue Number: T505U225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: 78 YR
• Patient Weight: 109