MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING TRI-AD 900SFC32; RING, ANNULOPLASTY

Model Number	900SFC32
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/02/2020
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 immediately post implant of this 32mm tricuspid annuloplasty ring, it was explanted and replaced with a 29mm bioprosthetic valve.There were no allegations against the ring or its function.The physician reported patient anatomy issues and determined replacing the valve would be better for the patient.No additional adverse patient were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed two sutures that appeared to have been cut on the outflow.Radiography showed no evidence of fractures on the ring.Conclusions: surgeons often attempt to repair valves in lieu of replacing them in an effort to preserve the native anatomy.There are times when valve repair is attempted using a repair device and subsequent post-repair evaluation demonstrates an inadequate result.This is potentially due to, but not limited to, suboptimal anatomy, surgical technique, or inappropriate sizing, rather than a malfunction of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING TRI-AD 900SFC32
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9877383
• Report Number: 2025587-2020-00950
• Device Sequence Number: 13602201
• Product Code: KRH
• UDI-Device Identifier: 00643169195370
• UDI-Public: 00643169195370
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093903
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 10/08/2023
• Device Model Number: 900SFC32
• Device Catalogue Number: 900SFC32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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