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

Model Number	39200
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The severely stenosed target lesion was located in the left femoral artery.After a 7f non-boston scientific sheath and a 0.035 amplatz guide wire crossed the lesion, a 7x60x120 epic vascular stent was advanced for treatment.After the stent reached the lesion, the handle roller could not be rotated and the stent could not be deployed even after repeated attempts.When the device was removed, the middle of the stent struts were found to be deformed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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 that the sheath is kinked 10cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that may have contributed to the deployment issues.
Event or Problem Description
It was reported that stent damage occurred.The severely stenosed target lesion was located in the left femoral artery.After a 7f non-boston scientific sheath and a 0.035 amplatz guide wire crossed the lesion, a 7x60x120 epic vascular stent was advanced for treatment.After the stent reached the lesion, the handle roller could not be rotated and the stent could not be deployed even after repeated attempts.When the device was removed, the middle of the stent struts were found to be deformed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• 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: 10726416
• Report Number: 2134265-2020-14631
• Device Sequence Number: 14310925
• Product Code: NIO
• UDI-Device Identifier: 08714729805489
• UDI-Public: 08714729805489
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/03/2020

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: 07/24/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024173622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/10/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: GUIDE WIRE: 0.035 AMPLATZ.; GUIDE WIRE: 0.035 AMPLATZ.; SHEATH: COOK 7F.; SHEATH: COOK 7F.; GUIDE WIRE: 0.035 AMPLATZ; SHEATH: COOK 7F
• Patient Age: 68 YR
• Patient Weight: 65