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

Model Number	H74939200081070
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event : 18 years or older.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 medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2017-11238.It was reported that in-stent restenosis (isr) occurred.On an unspecified date, an epic stent was implanted to treat a target lesion in the superficial femoral artery (sfa).In (b)(6) 2017, the patient presented for treatment of the 100% restenosed 8x100x75 epic¿ vascular stent located in a mildly tortuous and moderately calcified sfa.A 7.0mmx40mmx135 cm (4f) sterling¿ balloon catheter was advanced for dilatation.Upon inflation at 12 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7059500
• Report Number: 2134265-2017-12036
• Device Sequence Number: 1879873
• Product Code: NIO
• UDI-Device Identifier: 08714729805571
• UDI-Public: 08714729805571
• 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): 10/30/2017

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: 05/24/2022
• Device Model Number: H74939200081070
• Device Catalogue Number: 39200-08107
• Device Lot Number: 0020693058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/27/2017
• 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