MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	500DM29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	07/14/2017
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 during the implant of this 29 mm mechanical valve in a patient with rheumatic valve disease, due to annular rupture, the valve was explanted and replaced with a 25 mm valve of the same model.Subsequently the patient died.It was reported that the death was not related to the valve or its function nor was there any allegation that the valve contributed to the patient's death.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6793978
• Report Number: 3008592544-2017-00043
• Device Sequence Number: 137803
• Product Code: LWQ
• UDI-Device Identifier: 00643169335066
• UDI-Public: 00643169335066
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: 08/02/2021
• Device Model Number: 500DM29
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/15/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 69