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

Model Number	7700FR38
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	09/15/2020
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 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
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10701714
• Report Number: 2025587-2020-03154
• Device Sequence Number: 3709200
• Product Code: KRH
• UDI-Device Identifier: 00763000271138
• UDI-Public: 00763000271138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 07/09/2025
• Device Model Number: 7700FR38
• Device Catalogue Number: 7700FR38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/19/2020
• 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
• Patient Age: 21 YR
• Patient Weight: 95