MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING TRI-AD 900SFC32; RING, ANNULOPLASTY

Model Number 900SFC32

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 03/02/2020

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 immediately post implant of this 32mm tricuspid annuloplasty ring, it was explanted and replaced with a 29mm bioprosthetic valve.There were no allegations against the ring or its function.The physician reported patient anatomy issues and determined replacing the valve would be better for the patient.No additional adverse patient were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed two sutures that appeared to have been cut on the outflow.Radiography showed no evidence of fractures on the ring.Conclusions: surgeons often attempt to repair valves in lieu of replacing them in an effort to preserve the native 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING TRI-AD 900SFC32
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9877383
• MDR Text Key: 186315653
• Report Number: 2025587-2020-00950
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169195370
• UDI-Public: 00643169195370
• Combination Product (y/n): N
• PMA/PMN Number: K093903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: 900SFC32
• Device Catalogue Number: 900SFC32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention