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

Model Number	800SR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 5 days post implant of this 32 mm mitral annuloplasty ring, it was explanted and replaced with a 28mm mitral annuloplasty ring for unknown reasons.No additional adverse patient effects were reported.  medtronic received additional information that immediately post implant of the 28mm mitral annuloplasty ring it was explanted and replaced.After suturing the ring down securely, testing demonstrated significant central regurgitation.No additional 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: 7280485
• Report Number: 3008592544-2018-00013
• Device Sequence Number: 16447138
• Product Code: KRH
• UDI-Device Identifier: 00643169182226
• UDI-Public: 00643169182226
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K072655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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: 04/30/2021
• Device Model Number: 800SR
• Device Catalogue Number: 800SR28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/19/2018
• 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: 66 YR
• Patient Weight: 82