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

Model Number	39200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the true event date was not reported.The first day of the month of the aware date was used as an estimate.
Event or Problem Description
It was reported that stent detachment occurred.A 7x60x120 epic vascular stent was selected for used.However, during unpacking, it was noticed that the stent was detached from the delivery system.The procedure was completed with different device.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: the true event date was not reported.The first day of the month of the aware date was used as an estimate.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 3mm from the distal end of the sheath.There is a kink at the nose cone and another 77.5 cm from the nose cone.The lock is missing from the returned device.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 could have contributed to the reported event.
Event or Problem Description
It was reported that stent detachment occurred.A 7x60x120 epic vascular stent was selected for used.However, during unpacking, it was noticed that the stent was detached from the delivery system.The procedure was completed with different device.No patient complications were reported.

• 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: 11977607
• Report Number: 2134265-2021-07293
• Device Sequence Number: 14318739
• Product Code: NIO
• UDI-Device Identifier: 08714729805489
• UDI-Public: 08714729805489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 08/12/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025858381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1