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

Model Number	500DM29
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Hemolytic Anemia (2279); Complete Heart Block (2627)
Date of Event	08/23/2017
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.
Event or Problem Description
Medtronic received information that eight days post implant of this mitral mechanical valve, the electrocardiogram (ecg) showed complete heart block (chb) and subsequently a permanent pacemaker was implanted.Approximately three months post implant the patient was hospitalized for anemia with intermittent hemolysis.Blood transfusions were prescribed.Transesophageal echocardiogram (tee) showed mild paravalvular leak.Two years twenty-seven days post implant, the valve was explanted and replaced with a bioprosthetic valve.A transesophageal echocardiogram (tee) done post implant showed no paravalvular leak.No additional adverse patient effects were reported.

• 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: 6899072
• Report Number: 3008592544-2017-00052
• Device Sequence Number: 16308548
• Product Code: LWQ
• UDI-Device Identifier: 00643169335066
• UDI-Public: 00643169335066
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• 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: 09/04/2017
• Initial Report FDA Received Date: 09/27/2017
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 63