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

Model Number	620R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.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 an inadequate results.This is often due to suboptimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the device (1) without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(1) mick et al, ann cardiothorac surg 2015; 4(3):230-237.
Event or Problem Description
Medtronic received information that immediately following implant of this 31 mm annuloplasty ring in the mitral position, this device was explanted and replaced with a 29 mm annuloplasty ring.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6429884
• Report Number: 2025587-2017-00458
• Device Sequence Number: 10998678
• Product Code: KRH
• UDI-Device Identifier: 00613994758989
• UDI-Public: 00613994758989
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 07/11/2021
• Device Model Number: 620R
• Device Catalogue Number: 620RG31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 10/17/2017
• 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
• Patient Age: 70 YR