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

Model Number	H74939200084070
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental mdr will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified external iliac artery.After a guide wire crossed the lesion and pre-dilatation was performed, an 8x40x75 epic¿ vascular stent was advanced for treatment.However, the distal tip got caught in the calcification and it failed to cross the lesion.The device was completely removed and it was noted that the distal tip of the stent struts were slightly lifted.The procedure was completed with a different device.No patient complications were reported and the patient¿s status was stable.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7592738
• Report Number: 2134265-2018-05319
• Device Sequence Number: 1814090
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: 08714729805656
• Combination Product (Y/N): N
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: H74939200084070
• Device Catalogue Number: 39200-08407
• Device Lot Number: 21518627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1