MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG31
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Surgeons often attempt to repair mitral valves in lieu of replacing them due to improved long term clinical outcomes.There are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates inadequate results.This is often due to sub-optimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the device.The surgeon stated that there was no failure of the ring.It was replaced due to systolic anterior motion (sam).
Event or Problem Description
Medtronic received information that during the procedure to implant this annuloplasty ring, the ring was explanted and replaced with a non-medtronic valve.There was no failure of the ring.It was replaced due to systolic anterior motion (sam).No adverse patient effects were reported.

• Brand Name: RING 620RG31 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6930201
• Report Number: 2025587-2017-01793
• Device Sequence Number: 1089815
• Product Code: KRH
• UDI-Device Identifier: 00613994758989
• UDI-Public: 00613994758989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: 620RG31
• Device Catalogue Number: 620RG31
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/09/2017
• 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