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

Model Number	510
Medical Device Problem Codes	Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.
Event or Problem Description
Medtronic received information that three years post implant of this mitral bioprosthetic valve, the device was explanted and replaced for unknown reasons.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received indicated that the device was explanted and replaced due to increased gradients and regurgitation.No further adverse patient effects were 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.
Additional Manufacturer Narrative
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.

• Brand Name: HANCOCK II MITRAL 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: 6146813
• Report Number: 2025587-2016-01926
• Device Sequence Number: 10866577
• Product Code: LWR
• UDI-Device Identifier: 00643169027060
• UDI-Public: 00643169027060
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2017

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: 03/26/2015
• Device Model Number: 510
• Device Catalogue Number: T510C25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided; 01/16/2017
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/20/2017; 09/27/2017
• 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: 66 YR