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

Model Number	39200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inner shaft and outer sheath detachment occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left common iliac artery.A 7x80x75 epic vascular stent was advanced for treatment.However, during removal of the delivery system after stent deployment, the inner shaft and outer sheath were removed separately.The inner shaft was separated when the outer sheath part came out of the sheath.The inner shaft was also pulled out of the sheath but had stayed on the guidewire.There were no patient complications nor injuries reported and the patient condition was good.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1: (b)(6).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 inner liner is separated from the handle.Microscopic examination revealed no additional damages.The handle was opened to verify where the inner liner actually separated and it was confirmed to have been pulled out from the luer.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that inner shaft and outer sheath detachment occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left common iliac artery.A 7x80x75 epic vascular stent was advanced for treatment.However, during removal of the delivery system after stent deployment, the inner shaft and outer sheath were removed separately.The inner shaft was separated when the outer sheath part came out of the sheath.The inner shaft was also pulled out of the sheath but had stayed on the guidewire.There were no patient complications nor injuries reported and the patient condition was good.

• 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: 15580983
• Report Number: 2124215-2022-38432
• Device Sequence Number: 17738697
• Product Code: NIO
• UDI-Device Identifier: 08714729805533
• UDI-Public: 08714729805533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/07/2022

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: 0028796520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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 Sex: Unknown