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

Model Number	H74939200061020
Medical Device Problem Codes	Bent (1059); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(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 medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage and fracture occurred.Vascular access was obtained utilizing retrograde approach from the foot.The chronic totally occluded (cto) target lesion was located in the mildly tortuous and calcified superficial femoral artery (sfa).A 6x100x120 epic¿ vascular stent was advanced through the hunters canal back proximal to lower mid sfa through the segment where the cto was crossed earlier by the retrograde approach.The cto segment was hyper-dilated for the nature of the cto.The physician slowly flowered open the epic distally and once anchored, continued to thumbwheel release the stent.At which point the stent started to quickly foreshorten in the ectatic area.The stent then appeared to invaginate on itself and possibly fractured in that segment.The lesion was a calcified cto, however, the location where the stent had an issue was a very dilated area.A 5x200 charger pta balloon catheter was initially advanced from the traditional approach but failed to cross as the stent was not allowing passage in that direction.Therefore an additional 5x100 sterling balloon catheter was then advanced from the foot to cross and post-dilate the stent.The procedure was completed.The stent was left inside of the patient.No patient complications were reported and the patient was stable and was being discharged.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7555360
• Report Number: 2134265-2018-04699
• Device Sequence Number: 10799096
• Product Code: NIO
• UDI-Device Identifier: 08714729805205
• UDI-Public: 08714729805205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 01/19/2021
• Device Model Number: H74939200061020
• Device Catalogue Number: 39200-06102
• Device Lot Number: 18829820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/30/2018
• 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