MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 26MM; RING, ANNULOPLASTY

Model Number	680R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Surgeons often attempt to repair valves in lieu of replacing them to improve 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 result.This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring.The native valve was not repairable as it was subsequently explanted.
Event or Problem Description
Medtronic received information from this patient's physician that this valve was replaced due to recurrent mitral valve regurgitation.Upon opening the patient's left atrium and visualizing the valve, the physician noted that "the atrial chord in the p2 position appeared to be redundant and loose.The remainder of the valve appeared to be thickened, and the anterior leaflet prolapsed above the level of the annulus." an annuloplasty ring was implanted, and a "wedge resection performed of the flail segment of the p2 leaflet." this ring was subsequently explanted and replaced with a mechanical valve due to a "mild leak, which appeared to be secondary to the anterior leaflet prolapse." 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 PROFILE 3D 26MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6298314
• Report Number: 2025587-2017-00185
• Device Sequence Number: 810741
• Product Code: KRH
• UDI-Device Identifier: 00613994759252
• UDI-Public: 00613994759252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073324
• 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,Followup
• Report Date (Section B): 10/26/2016

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: 03/16/2021
• Device Model Number: 680R
• Device Catalogue Number: 680R26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 67 YR