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

Model Number	T505C221
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received information that 4 years and 8 months post implant of this aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve.It was reported the surgical valve was calcified.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
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: 8731477
• Report Number: 2025587-2019-02033
• Device Sequence Number: 2022558
• Product Code: DYE
• UDI-Device Identifier: 00643169000315
• UDI-Public: 00643169000315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 10/27/2016
• Device Model Number: T505C221
• Device Catalogue Number: T505C221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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: 80 YR
• Patient Weight: 60