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

Model Number 620BG31

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

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

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

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 immediately following the implant of this 31mm mitral annuloplasty band, it was explanted and replaced with a 27mm band of the same model.The reason for explant is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that after suturing in and testing the 31mm annuloplasty band, residual mitral regurgitation was noted.It was explanted and successfully replaced with a 27mm band of the same model.The surgeon stated that the band was "over-sized relative to the patient's needs.It was not defective".No additional adverse patient effects were reported. 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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8126554
• MDR Text Key: 129107851
• Report Number: 2025587-2018-03282
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: 620BG31
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/29/2018
• Supplement Dates FDA Received: 01/14/2019
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 66