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

Model Number	T510C31
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiomyopathy (1764); Death (1802)
Date of Event	08/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 620bg27, serial/lot #: (b)(4), (b)(6), (b)(4).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 5 months post implant of this mitral annuloplasty band, the band was explanted and replaced with a bioprosthetic valve.The reason for explant was not reported.Subsequently, 6 days post implant of the bioprosthetic valve, the patient died.The cause of death was not received.There was no evidence to suggest that the valve or its function contributed to the patient¿s death.It is unknown whether an autopsy was performed.
Additional Manufacturer Narrative
Medtronic received additional information that the annuloplasty band was replaced due to progression of cardiomyopathy with posterior leaflet restriction and posterior wall dysfunction.The physician reported the cause of death was also due to cardiomyopathy and was unrelated to the bioprosthetic valve.No autopsy was performed.Patient weight added.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Outcome attributed to adverse event was corrected and refers to product id: 620bg27, serial/lot #: (b)(4), ubd: 12-oct-2022, udi#: (b)(4).Date mfr rec additional information was corrected.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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7895521
• Report Number: 2025587-2018-02473
• Device Sequence Number: 16599073
• Product Code: LWR
• UDI-Device Identifier: 00643169594425
• UDI-Public: 00643169594425
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2018

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: 03/18/2021
• Device Model Number: T510C31
• Device Catalogue Number: T510C31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 09/18/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 09/25/2018; 10/24/2018
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 56