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

Model Number	T510C25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Death (1802); Exsanguination (1841); Rupture (2208)
Date of Event	09/26/2019
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 regurgitation.At the time of admission to the hospital, it was reported that the patient was coagulopathic.The patient's mitral annulus was extensively calcified and was debrided.Following the decalcification, a ridge of calcium remained on the annulus.The calcified portion of the annulus was covered with a strip of bovine pericardium prior to implanting this bioprosthetic mitral valve.The valve was successfully implanted with no regurgitation or bleeding noted.Following mitral valve replacement, the patient's tricuspid valve was repaired with a non-medtronic annuloplasty ring.Temporary pacing wires were inserted in the left and right atrial appendages and the right ventricle.While attempting to remove this patient from cardiopulmonary bypass (cpb), bleeding was noted behind the heart.It was reported that the bleeding was coming the union of the left atrial appendage and the left atrium.The lesion was attempted to be repaired for several hours.It was reported that spontaneous dehiscence of the crux of the heart occurred.Ultimately the patient expired in the operating room due to exsanguination.The cause of the atrioventricular groove rupture that lead to the death was not reported.
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): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9985427
• Report Number: 2025587-2020-01341
• Device Sequence Number: 11872547
• Product Code: LWR
• UDI-Device Identifier: 00643169594449
• UDI-Public: 00643169594449
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 11/30/2020
• Device Model Number: T510C25
• Device Catalogue Number: T510C25
• 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: 06/22/2020
• 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: 73 YR
• Patient Weight: 68