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

Model Number	39202
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed.An epic vascular stent was selected for use for a balloon dilation and percutaneous interventional procedure of the iliac artery in the right lower extremity to treat arterial stenosis.The physician attempted to deploy the stent in the lesion using the thumbwheel, however, the thumbwheel could no longer be used after the top of the stent was deployed.The physician then withdrew the entire stent delivery system completely.There were no patient complications reported.
Additional Manufacturer Narrative
Additional information to event description.Correction to device code.
Event or Problem Description
It was reported that the stent partially deployed.An epic vascular stent was selected for use for a balloon dilation and percutaneous interventional procedure of the iliac artery in the right lower extremity to treat arterial stenosis.The physician attempted to deploy the stent in the lesion using the thumbwheel, however, the thumbwheel could no longer be used after the top of the stent was deployed.The physician then withdrew the entire stent delivery system completely.There were no patient complications reported.It was further reported that the stent was deployed a little, and the stent was not fully apposed to the vessel walls.There was no stent damage.The procedure was completed with a different device.No patient complications were 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: 8403495
• Report Number: 2134265-2019-02205
• Device Sequence Number: 297966
• Product Code: NIO
• UDI-Device Identifier: 08714729805564
• UDI-Public: 08714729805564
• 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): 03/25/2019

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: 02/28/2019
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 18926444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 70