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

Model Number	620BG31
Medical Device Problem Codes	Incomplete Coaptation (2507); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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. .
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7985020
• Report Number: 2025587-2018-02781
• Device Sequence Number: 183177
• Product Code: KRH
• UDI-Device Identifier: 00613994759122
• UDI-Public: 00613994759122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: 01/09/2022
• Device Model Number: 620BG31
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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: 73 YR
• Patient Weight: 94