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

Model Number 620BG31

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); No Information (3190)

Event Date 07/18/2019

Event Type  Injury  

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 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.

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
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8852607
• MDR Text Key: 153079291
• Report Number: 2025587-2019-02450
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759122
• UDI-Public: 00613994759122
• Combination Product (y/n): N
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Model Number: 620BG31
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 88