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

Model Number	800SR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/05/2017
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 an unknown duration following implant of this mitral ring, it was explanted and replaced for unknown reasons.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received from the health care facility (hcf) where this patient had their implant procedure done approximately one month prior to this call, stated that there has been no additional procedure done at this facility and as far as they are aware the patient still has their devices implanted.The patient has a 38mm mitral annuloplasty ring and a 25mm non medtronic aortic valve.Nothing further was completed on this patient since their implant at that facility.Updated patient and device codes.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 east deere ave.; santa ana CA 92705
• MDR Report Key: 7158164
• Report Number: 3008592544-2018-00001
• Device Sequence Number: 832574
• Product Code: KRH
• UDI-Device Identifier: 00643169182240
• UDI-Public: 00643169182240
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K072655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2018

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: 05/31/2022
• Device Model Number: 800SR
• Device Catalogue Number: 800SR38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/05/2018; 01/08/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/08/2018; 01/10/2018
• 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: 72 YR