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

Model Number	39202
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the outer sheath detached.The 100% stenosed target lesion was located in the severly tortuous and severly calcified left common iliac artery.A 10mm x 100mm x 75mm epic vascular stent was advanced for treatment using an ipsilateral antegrade approach.After the guidewire was passed through, the epic stent was delivered after pre-dilatation was performed, however, it failed to deploy.When trying to remove the device, the outer sheat became separated/detached.The procedure completed with another of same device.There were no patient complications reported and the patient's status post procedure was reported as stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer; the outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed buckling to the middle sheath 11.3cm approximately 1.1cm long and another buckling 15.9cm from the distal end of the middle sheath.The middle sheath appears wavy between the buckled area.The rack was not fully deployed and is still approximately 37mm from the handle.The inner liner is kinked 1.9cm, 8.4cm, and 9.8cm from the tip.Microscopic examination revealed that the inner liner appears stretched in three places.The first starts at the proximal end of the tip and is approximately 9mm long.The second stretch is 6.6cm from the proximal end of the tip and is approximately 8mm long.The third stretch is approximately 7.6cm from the proximal end of the tip and ends somewhere in the middle sheath but it could not be seen.The stent is missing and did not return for analysis.There is blood present in the middle sheath.The device was functionally tested by rotating the thumbwheel and the sheath started to move proximally as intended.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed damages to the device that can potentially cause deployment issues.
Event or Problem Description
It was reported that the outer sheath detached.The 100% stenosed target lesion was located in the severly tortuous and severly calcified left common iliac artery.A 10mm x 100mm x 75mm epic vascular stent was advanced for treatment using an ipsilateral antegrade approach.After the guidewire was passed through, the epic stent was delivered after pre-dilatation was performed, however, it failed to deploy.When trying to remove the device, the outer sheath became separated/detached.The procedure completed with another of same device.There were no patient complications reported and the patient's status post procedure was reported as stable.It was further reported that the outer sheath was accordioned and not separated/detached.The damage was located within 10cm from the hub, but the exact location was unknown.The patient's current condition was good.

• 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: 8444398
• Report Number: 2134265-2019-02885
• Device Sequence Number: 2051593
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: 08714729805113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 03/23/2022
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0020445621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/15/2019
• 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: RADIFOCUS GUIDEWIRE; RADIFOCUS GUIDEWIRE; TERUMO 6FR INTRODUCER SHEATH; TERUMO 6FR INTRODUCER SHEATH; RADIFOCUS GUIDEWIRE; TERUMO 6FR INTRODUCER SHEATH