MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC FLEX; HEART-VALVE, MECHANICAL

Model Number	500FA27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker.A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.The device remains implanted.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 four days post implant of this aortic mechanical valve, a permanent pacemaker was implanted due to complete heart block.No additional adverse patient effects were reported. .

• Brand Name: AORTIC FLEX
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 7809705
• Report Number: 3008592544-2018-00032
• Device Sequence Number: 1052851
• Product Code: LWQ
• UDI-Device Identifier: 00643169335127
• UDI-Public: 00643169335127
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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: 12/13/2021
• Device Model Number: 500FA27
• Device Catalogue Number: 500FA27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/23/2018
• 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: Required Intervention
• Patient Age: 65 YR