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

Model Number	T505
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Dyspnea (1816); No Information (3190)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.
Event or Problem Description
Medtronic received information that 2 years 2 months post implant of this bioprosthetic aortic valve, this device was replaced, valv e-in-valve with a transcatheter bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this device was replaced due to severe aortic stenosis and moderate insufficiency.Prior to the replacement procedure, the patient presented with functional class iv (b)(6) symptoms, including chest pain and shortness of breath on exertion.The patient was in stable condition following replacement, and nothing out of the ordinary occurred.Patient's weight added.Patient's relevant medical history added.(b)(4).
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 AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6347670
• Report Number: 2025587-2017-00282
• Device Sequence Number: 744310
• Product Code: LWR
• UDI-Device Identifier: 00643169000438
• UDI-Public: 00643169000438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/10/2017

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: 08/21/2017
• Device Model Number: T505
• Device Catalogue Number: T505U223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided; 03/10/2017
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/10/2017; 09/29/2017
• 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: 33 YR
• Patient Weight: 77