MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number	800SR34
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Patient weight is approximate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this 34mm annuloplasty ring was implanted 19 days post expiration date.It was reported that "surgeon knowingly implanted expired product".No adverse patient effects were reported.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12062494
• Report Number: 2025587-2021-01995
• Device Sequence Number: 17297163
• Product Code: KRH
• UDI-Device Identifier: 00643169182264
• UDI-Public: 00643169182264
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 800SR34
• Device Catalogue Number: 800SR34
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 80