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

Model Number	39200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 8x60x120 epic vascular stent was unpacked.However, during preparation, it was found that the front end of the stent was damaged.The procedure was completed with another of the same device.There were no patient complications and the patient was stable post procedure.
Event or Problem Description
It was reported that stent damage occurred.A 8x60x120 epic vascular stent was unpacked.However, during preparation, it was found that the front end of the stent was damaged.The procedure was completed with another of the same device.There were no patient complications and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer shaft, inner shaft, and tip were visually and microscopically examined.Visual examination revealed that the stent is partially deployed 7mm from the middle sheath.There is a kink to the middle sheath 7cm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The lock is still on the rack.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the stent is partially deployed.

• 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: 9395471
• Report Number: 2134265-2019-14722
• Device Sequence Number: 1763064
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: 08714729805687
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: 08/22/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022554511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR