MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION BAND 620BG29 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620B
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)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product specimen has not been returned for device analysis.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that immediately following implant of this annuloplasty band, it was explanted and replaced with a bioprosthetic valve.This repair of the native valve failed and there was no allegation against this annuloplasty device itself.No other adverse patient effects were reported.

• Brand Name: BAND 620BG29 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: 6708451
• Report Number: 2025587-2017-01158
• Device Sequence Number: 19092255
• Product Code: KRH
• UDI-Device Identifier: 00613994759108
• UDI-Public: 00613994759108
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: 08/24/2021
• Device Model Number: 620B
• Device Catalogue Number: 620BG29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/12/2017
• 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: 36 YR