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

Model Number	310C27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/21/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or c 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 product 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 mitral bioprosthetic valve, a permanent pacemaker was implanted.The indication for pacemaker implant is unknown.No additional adverse patient effects were reported. .

• Brand Name: MOSAIC 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: 7966501
• Report Number: 2025587-2018-02736
• Device Sequence Number: 16185512
• Product Code: LWR
• UDI-Device Identifier: 00613994689207
• UDI-Public: 00613994689207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 10/31/2013
• Device Model Number: 310C27
• Device Catalogue Number: 310C27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/15/2018
• 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: 70 YR