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

Model Number	T510C27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Exsanguination (1841); Tissue Damage (2104); Rupture (2208)
Date of Event	03/18/2020
Type of Reportable Event	Death
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 this patient underwent mitral valve replacement due to severe mitral stenosis secondary to calcification, as well as moderate mitral regurgitation.It was reported that the patient's right atrium was "very thin" and dilated in all cavities.It was also reported that the tissue on the atrioventricular groove was poor, which the surgeon reported was a sign of chronic inflammation.The valve was successfully implanted with no regurgitation or bleeding noted.Following mitral valve replacement, prior to discontinuing cardiopulmonary bypass (cpb), the right ventricle became dilated and the pulmonary artery was "tense".A pulmonary sump was implanted which was reported to decompress the heart.Temporary pacing wires were inserted in the left appendage.While attempting to remove this patient from cardiopulmonary bypass (cpb), bleeding was noted behind the heart.It was reported that the bleeding was determined to be a result of spontaneous rupture of the crux of the heart secondary to distention of the heart once the heart had started beating again.The rupture was attempted to be repaired for several hours.Ultimately the patient expired in the operating room due to exsanguination.No autopsy was performed.
Additional Manufacturer Narrative
A device history review was performed on the device; there were no correlations / issues identified regarding manufacturing that could have impacted 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.Based on input from medtronics office of medical affairs, the cause of death was likely due to patient co-morbidities.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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9985440
• Report Number: 2025587-2020-01342
• Device Sequence Number: 11872548
• Product Code: LWR
• UDI-Device Identifier: 00643169594456
• UDI-Public: 00643169594456
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 01/21/2021
• Device Model Number: T510C27
• Device Catalogue Number: T510C27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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: Death
• Patient Age: 79 YR
• Patient Weight: 79