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

Model Number	39202
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that stent profile issue occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel in the upper arm.A 7x100x75mm epic stent was selected to overlap a previously placed 7.0x40 epic stent on the central side.The stent was positioned and deployed without issues.After deployment, the stent length measured to be 124mm.The intended treatment was completed and the procedure was completed with no further intervention.No patient complications were reported.
Event or Problem Description
It was reported that stent profile issue occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel in the upper arm.A 7x100x75mm epic stent was selected to overlap a previously placed 7.0x40 epic stent on the central side.The stent was positioned and deployed without issues.After deployment, the stent length measured to be 124mm.The intended treatment was completed and the procedure was completed with no further intervention.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).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 a kink to the inner liner 12.4cm from the tip.Microscopic examination revealed no additional damages.Media was provided by the customer in the form of 4 pictures.The first picture shows the measurement of the 40mm stent.The second picture showed the measurement of the implanted 100mm stent measuring at roughly 124mm.The stent does appear to be deformed at the top section.The third picture shows what appears to be the location of the stent after it is deployed.The fourth picture shows the stent before it is implanted.The stent does appear slightly longer than before it was implanted.Inspection of the remainder of the device presented no other 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: 11152039
• Report Number: 2134265-2020-18858
• Device Sequence Number: 3383454
• Product Code: NIO
• UDI-Device Identifier: 08714729805557
• UDI-Public: 08714729805557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/18/2021

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: 09/07/2025
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0025982710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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: YOROI 7MMX40MM; BALLOON CATHETER: YOROI 7MMX40MM; GUIDEWIRE: AQUA V3; GUIDEWIRE: AQUA V3; INFLATION DEVICE: EVEREST; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: MEDIKIT ULTRA HI-FLOW; INTRODUCER SHEATH: MEDIKIT ULTRA HI-FLOW; MICRO CATHETER: CARRY; MICRO CATHETER: CARRY; BALLOON CATHETER: YOROI 7MMX40MM; GUIDEWIRE: AQUA V3; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: MEDIKIT ULTRA HI-FLOW; MICRO CATHETER: CARRY