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

Model Number 620BG31

Device Problems Incomplete Coaptation (2507); Insufficient Information (3190)

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

Event Date 10/02/2018

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 five months and twenty-seven days post implant of this 31mm mitral annuloplasty ring, the ring was explanted and replaced with a 25mm bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported. .

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that five months and twenty-seven days post implant of this 31mm mitral annuloplasty band, the band was explanted and replaced with a 25mm bioprosthetic valve.The reason for explant was reported as severe mitral regurgitation, with retraction of the anterior leaflet.A gap was noted between the anterior and posterior leaflets, along with the a3 and p3.Despite multiple attempts to wean from bypass, the right ventricle (rv) was not functioning as expected.The surgeon placed the patient on extracorporeal membrane oxygenation (ecmo) and no additional adverse patient effects were reported. .

• 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
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 7985020
• MDR Text Key: 124349095
• Report Number: 2025587-2018-02781
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759122
• UDI-Public: 00613994759122
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: 620BG31
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Date Device Manufactured: 01/10/2017
• 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: 73 YR
• Patient Weight: 94