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

Model Number 620RG27

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 03/04/2020

Event Type  Injury  

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 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.

Manufacturer Narrative

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

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
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9824500
• MDR Text Key: 183157240
• Report Number: 2025587-2020-00759
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793385
• UDI-Public: 00643169793385
• Combination Product (y/n): N
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention