MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION BAND 620BG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620BG31
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Regurgitation (1964); No Information (3190)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 1 year and 6 months post implant of this 31mm mitral annuloplasty band, it was explanted and replaced with a 29mm bioprosthetic valve.The reason for replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that the reason for replacement was due to severe mitral regurgitation, extensive annular calcification extending from mid p3 through all of p2, along with exertional dyspnea.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BAND 620BG31 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: 8852607
• Report Number: 2025587-2019-02450
• Device Sequence Number: 318501
• Product Code: KRH
• UDI-Device Identifier: 00613994759122
• UDI-Public: 00613994759122
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 11/29/2021
• Device Model Number: 620BG31
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: 80 YR
• Patient Weight: 88