MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG27 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Pannus (1447); Mitral Valve Prolapse (2471)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: received in a clear 0.2% glutaraldehyde solution in an explant kit.The flexible band appeared open or relaxed.Glistening off white pannus remained attached to the inflow and outflow aspects of the band.Radiography showed traces of mineralization along the band.Radiography shows no evidence of breaks or fractures along the band conclusion: the analysis of the device noted pannus.Pannus is an inherent risk of implantable devices.The amount of pannus on the device does not suggest that the event occurred at index procedure.Pannus related risks are documented in the risk management files.There is no indication of product quality issue found during the analysis.
Event or Problem Description
Medtronic received information that approximately 8 years post implant of this mitral annuloplasty band, the patient presented with a ruptured neochord with a prolapsed anterior leaflet.There was also dilation of the annulus with incomplete coaptation of the anterior and posterior leaflet.The device was explanted and replaced with a bioprosthetic valve.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 620RG27 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: 6421283
• Report Number: 2025587-2017-00440
• Device Sequence Number: 16376896
• Product Code: KRH
• UDI-Device Identifier: 00613994758941
• UDI-Public: 00613994758941
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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: 07/05/2021
• Device Model Number: 620RG
• Device Catalogue Number: 620RG27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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
• Patient Weight: 97