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

Model Number	39200
Medical Device Problem Codes	Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent and partial stent deployment occurred.The target lesion was located in the superficial femoral artery of the right lower extremity.A 6x60x120 epic stent was selected for use.However, when the device was taken out from the protective sleeve, it was noted that the first and second sections of the stent were deployed and could not be reconstrained back into the delivery system.The device was completely removed without any issue.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 stent is partially deployed 1cm from the distal end of the middle sheath.The inner liner is kinked 1.6cm and 3.3cm from the tip.Microscopic examination revealed no additional damages.The lock is still on the rack.Inspection of the remainder of the device presented no damage or irregularities.
Event or Problem Description
It was reported that inadvertent and partial stent deployment occurred.The target lesion was located in the superficial femoral artery of the right lower extremity.A 6x60x120 epic stent was selected for use.However, when the device was taken out from the protective sleeve, it was noted that the first and second sections of the stent were deployed and could not be reconstrained back into the delivery system.The device was completely removed without any issue.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: 10048486
• Report Number: 2134265-2020-06234
• Device Sequence Number: 2916408
• Product Code: NIO
• UDI-Device Identifier: 08714729805328
• UDI-Public: 08714729805328
• 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): 06/22/2020

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: 06/10/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022235174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 50