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

Model Number	620RG27
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2020
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 during the implant of this 27mm annuloplasty ring, it was incorrectly sized and was replaced with the same model 25mm ring.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the band was discolored and stained showing evidence of blood contact.Small needle holes were observed along the ring showing placement of implantation sutures.The ring appears to have been cut on both ends.Radiography showed no evidence of fractures on the ring.Conclusions: analysis showed no issues were observed with the annuloplasty ring related to the event.Surgeons often attempt to rep air 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, suboptimal anatomy, surgical technique, or inappropriate sizing, rather than a malfunction of the device.In this case, it was reported that the ring was incorrectly sized, and a smaller ring was implanted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING 620RG27 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9824500
• Report Number: 2025587-2020-00759
• Device Sequence Number: 16501803
• Product Code: KRH
• UDI-Device Identifier: 00643169793385
• UDI-Public: 00643169793385
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2020

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: 10/31/2023
• Device Model Number: 620RG27
• Device Catalogue Number: 620RG27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020; 08/07/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/12/2020; 08/13/2020
• 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