MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200074070
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was not returned.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the common iliac artery.A 7x40x75 epic¿ vascular stent was advanced to treat the lesion.However, post stent deployment, it was noted that the edge of the stent struts were lifted.A non-bsc stent was then deployed as additional treatment and the procedure was completed.No patient complications nor injuries were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7566171
• Report Number: 2134265-2018-04834
• Device Sequence Number: 11144006
• Product Code: NIO
• UDI-Device Identifier: 08714729805458
• UDI-Public: 08714729805458
• Combination Product (Y/N): N
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: H74939200074070
• Device Catalogue Number: 39200-07407
• Device Lot Number: 0020887833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: PARENT
• Outcome Attributed to Adverse Event: Required Intervention