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

Model Number	H74939200124070
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.After a 0.018 inch non-bsc guide wire crossed the lesion and pre-dilatation was performed with a 4mm balloon catheter, a 12x40x75 epic¿ vascular stent was advanced to treat the lesion.However, the distal tip of the device was caught by the calcification and an existing coil in the lesion, and the device failed to cross the lesion.The device was removed from the patient's body and the tip portion of the stent struts were found to be lifted up.The procedure was completed with a different device and no patient complications were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6142311
• Report Number: 2134265-2016-10943
• Device Sequence Number: 13765315
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: (01)08714729805151(17)20210412(10)19140313
• 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): 11/11/2016

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: 04/12/2021
• Device Model Number: H74939200124070
• Device Catalogue Number: 39200-12407
• Device Lot Number: 19140313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 12/02/2016
• 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: GUIDEWIRE: 0.018 INCH TREASURE