MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMPLICI-T BAND; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	670100
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	09/05/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this annuloplasty band was implanted in the tricuspid position and explanted during the same procedure.The reason for explant is unknown.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the reason this device was not used was due to unsuccessful valve repair.The patients native leaflet tissue was partially missing, necessitating the need for a complete valve replacement with a non medtronic valve.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMPLICI-T BAND
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7940321
• Report Number: 2025587-2018-02666
• Device Sequence Number: 2254921
• Product Code: LWR
• UDI-Device Identifier: 00613994759276
• UDI-Public: 00613994759276
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 12/18/2018
• Device Model Number: 670100
• Device Catalogue Number: 670100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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: 39 YR
• Patient Weight: 53