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

Model Number	T510
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Mitral Regurgitation (1964); Renal Failure (2041); No Information (3190)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that 11 months post implant of this bioprosthetic valve, it was explanted and replaced.No failure mechanism was provided.No other adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional clarifying information that the patient collapsed at home 9 months and 27 days post implant of this bioprosthetic mitral valve due to respiratory failure, severe systemic inflammatory response syndrome (sirs) picture, renal failure, multisystem organ failure.The patient went into a coma.It was noted that there was possible vegetation (location unknown).An aortic valve abscess and mitral valve regurgitation was noted.This patient was considered a poor surgical candidate at the time.Subsequently 10 months and 21 days post implant of the bioprosthetic mitral valve the valve was explanted and replaced with another medtronic bioprosthetic mitral valve.No further adverse patient effects were reported.The product was not returned for analysis as it was sent to hospital pathology.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: 6494541
• Report Number: 2025587-2017-00592
• Device Sequence Number: 884526
• Product Code: LWR
• UDI-Device Identifier: 00643169534155
• UDI-Public: 00643169534155
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2017

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: 06/14/2018
• Device Model Number: T510
• Device Catalogue Number: T510C29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 04/10/2017; 08/14/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/12/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 54