MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING 620RG35 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 4 years 3 months post implant of this 35mm mitral annuloplasty band was explanted and replaced for unknown reasons.A new 29mm mitral annuloplasty band was opened but ultimately not used, eventually the patient received a competitor device in its place.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this 35mm mitral annuloplasty band was explanted and replaced due to severe mitral regurgitation.A new 29mm mitral annuloplasty band was implanted, however did not repair the issue.Per the physician it was a failed repair due to anatomical issues and not due to a device issue.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING 620RG35 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7044852
• Report Number: 2025587-2017-02191
• Device Sequence Number: 19032493
• Product Code: KRH
• UDI-Device Identifier: 00613994759160
• UDI-Public: 00613994759160
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 12/18/2017

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: 04/21/2018
• Device Model Number: 620B
• Device Catalogue Number: 620BG35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/18/2017
• 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: 57 YR