MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number	39200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.After successful deployment of a 10mm x 60mm x 75cm epic stent, the stent delivery system was stuck with the.035 non-bsc guidewire and were removed together.A new wire was used and the procedure was completed.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that device entrapment occurred.After successful deployment of a 10x60x75mm epic stent, the stent delivery system was stuck with the.035 non-bsc guidewire and were removed together.A new wire was used and the procedure was completed.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system with a 0.035 inch guidewire stuck inside.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the sheath is bent at 45cm and 47.5cm from the nosecone.Microscopic examination revealed multiple buckling to the inner liner.Inspection of the remainder of the device presented no damage or irregularities.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10382066
• Report Number: 2134265-2020-10657
• Device Sequence Number: 19379663
• Product Code: NIO
• UDI-Device Identifier: 08714729805052
• UDI-Public: 08714729805052
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 12/13/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023083587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/04/2020
• 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: .035 COOK ROSEN; GUIDEWIRE: .035 COOK ROSEN