MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMUPLUS FLEXIBLE ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 7700FR38

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 09/15/2020

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 38mm mitral annuloplasty ring, it was explanted and replaced with a 34mm annuloplasty ring of a different model.The reason for the replacement was reported as a sizing issue, and that there was no issue with the annuloplasty ring itself.It was also reported that this was the physician's first time using this product.No additional adverse patient effects were reported.

• Brand Name: SIMUPLUS FLEXIBLE ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10701714
• MDR Text Key: 212064392
• Report Number: 2025587-2020-03154
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00763000271138
• UDI-Public: 00763000271138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7700FR38
• Device Catalogue Number: 7700FR38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 95