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	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent inadvertent deployment occurred.Vascular access was obtained via the femoral artery.The 80% stenosed target lesion was located in a severely tortuous and severely calcified right iliac artery.An 8x40x120 epic vascular stent was selected for use; however, when the physician opened the package, he found the stent was outside the protective delivery sheath.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.Vascular access was obtained via the femoral artery.The 80% stenosed target lesion was located in a severely tortuous and severely calcified right iliac artery.An 8x40x120 epic vascular stent was selected for use; however, when the physician opened the package, he found the stent was outside the protective delivery sheath.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: 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 buckling to the sheath 15.7cm from the distal end of the sheath.The microscopic examination revealed no additional damages.The rack is inside the handle and the lock is missing.The stent appears to have been deployed and did not return for analysis.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15320873
• Report Number: 2124215-2022-30852
• Device Sequence Number: 5124826
• Product Code: NIO
• UDI-Device Identifier: 08714729805649
• UDI-Public: 08714729805649
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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 Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0028909843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male