MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number	700FC
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this mitral annuloplasty band was implanted and explanted on the same day for unknown reasons.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received indicated that, according to the physician, "the native mitral valve was very abnormal with a very marked elongation predominately of the p2m and less so of the p2i." the native leaflet was markedly elongated and prolapsed.The device was removed due to it not pulling in the prolapse appropriately.The device was not sutured into place prior to being removed.The physician decided that a smaller sized device was required to fix the abnormality of the native tissue, so a 37mm annuloplasty band was implanted during the procedure.No adverse patient effects were reported.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• MDR Report Key: 6732244
• Report Number: 2025587-2017-01215
• Device Sequence Number: 1243902
• Product Code: KRH
• UDI-Device Identifier: 00643169182332
• UDI-Public: 00643169182332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052565
• 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,Followup
• Report Date (Section B): 08/09/2017

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: 08/31/2021
• Device Model Number: 700FC
• Device Catalogue Number: 700FC39
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/09/2017
• 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: 52 YR
• Patient Weight: 125