MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638RL26
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that immediately post implant of this 26mm mitral annuloplasty ring, it was explanted and replaced with a non-medtronic bioprosthetic valve.The reason for replacement was reported as moderate residual regurgitation.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, visual evaluation showed damage on the sewing cloth adjacent to the trigonal marker, likely resulting from suture placement through the eyelet.From the inflow, the sewing cloth and green suture was frayed.Radiography showed no evidence of distortion or fractures in the ring.Conclusion: surgeons often attempt to repair valves in lieu of replacing them in an effort to preserve the native mitral anatomy.There are times when valve repair is attempted using a repair device and subsequent post-repair evaluation demonstrates an inadequate result.This is potentially due to, but not limited to, sub-optimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9104421
• Report Number: 2025587-2019-02890
• Device Sequence Number: 2165040
• Product Code: KRH
• UDI-Device Identifier: 00643169793514
• UDI-Public: 00643169793514
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 01/12/2023
• Device Model Number: 638RL26
• Device Catalogue Number: 638RL26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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