MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMUFORM ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	7800RR26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.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 this patient underwent mitral valve surgery due to severe mitral valve regurgitation related to bacterial endocarditis.The patient's native mitral valve had an abscess and a perforation on the p1 leaflet.The surgeon repaired the leaflets and supported the valve with a 26mm flexible annuloplasty band.There is no mention in the operative report about this 26mm annuloplasty ring, but a device identification card for this serial number was submitted to medtronic and indicated that the product was "explanted".It is unclear if this ring was attempted prior to the implant of the 26mm band.The patient tolerated the procedure well and no adverse patient effects were noted.

• Brand Name: SIMUFORM ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10786031
• Report Number: 2025587-2020-03430
• Device Sequence Number: 11670127
• Product Code: KRH
• UDI-Device Identifier: 00763000271176
• UDI-Public: 00763000271176
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 07/21/2025
• Device Model Number: 7800RR26
• Device Catalogue Number: 7800RR26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/04/2020
• 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: 64 YR