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

Model Number	39200
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was entrapped on the guidewire and difficult to remove.The 90% stenosed target lesion was located in severely tortuous and moderately calcified common iliac artery.After crossing the lesion with a non-bsc guidewire, pre-dilatation was performed with a sterling balloon catheter.Subsequently, a 10x40x75 epic stent was advanced but could not advance through the tortuous vessel before the lesion.The guidewire was replaced with another non-bsc guidewire but it was stuck in the lumen and the epic stent was difficult to remove from the introducer sheath.The device was removed, lumen was flushed again, and then brought to the lesion with another guidewire but the same issue occurred.It was determined that the lumen was kinked.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed no damages.Microscopic examination revealed a twist to the inner liner 16mm from the tip.Device to device interaction test was performed by inserting a test guidewire into the tip and it was unable to pass the twisted area.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the catheter was entrapped on the guidewire and difficult to remove.The 90% stenosed target lesion was located in severely tortuous and moderately calcified common iliac artery.After crossing the lesion with a non-bsc guidewire, pre-dilatation was performed with a sterling balloon catheter.Subsequently, a 10x40x75 epic stent was advanced but could not advance through the tortuous vessel before the lesion.The guidewire was replaced with another non-bsc guidewire but it was stuck in the lumen and the epic stent was difficult to remove from the introducer sheath.The device was removed, lumen was flushed again, and then brought to the lesion with another guidewire but the same issue occurred.It was determined that the lumen was kinked.The procedure was completed with another of same device.There were no patient complications nor injuries reported.

• 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: 11237580
• Report Number: 2134265-2021-00790
• Device Sequence Number: 19794042
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: 08714729805014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 02/18/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023364950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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: BALLOON CATHETER USED: STERLING; BALLOON CATHETER USED: STERLING; GUIDEWIRE USED: CHEVALIER; GUIDEWIRE USED: CHEVALIER; GUIDEWIRE USED: TERUMO RADIFOCUS; GUIDEWIRE USED: TERUMO RADIFOCUS; INTRODUCER SHEATH USED: PARENT; INTRODUCER SHEATH USED: PARENT; BALLOON CATHETER USED: STERLING; GUIDEWIRE USED: CHEVALIER; GUIDEWIRE USED: TERUMO RADIFOCUS; INTRODUCER SHEATH USED: PARENT