MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG27 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Mitral Insufficiency (1963)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the mitral valve was initially repaired with this 27mm mitral annuloplasty ring and 6 gore-tex n eochordae placed to the p2 and p3 posterior leaflets.The physician reported the valve showed senile degeneration and calcification of the ruptured cords.Several anterior leaflet strut cords were similarly aged, thinned, and fragile.There was a paucity of tissue in the p2 posterior leaflet region that was suggestive of old endocarditis.The valve failed hydrostatic testing with moderate insufficiency and was therefore replaced with a 27mm non-medtronic bioprosthetic valve.No additional adverse patient effects were reported. .

• Brand Name: RING 620RG27 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: 7469429
• Report Number: 2025587-2018-01007
• Device Sequence Number: 114043
• Product Code: KRH
• UDI-Device Identifier: 00613994758941
• UDI-Public: 00613994758941
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: 08/29/2021
• Device Model Number: 620RG27
• Device Catalogue Number: 620RG27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/27/2018
• 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: 71 YR