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

Model Number	39200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.The patient underwent abdominal aortography and iliac artery stenting.Vascular access was obtained via the femoral artery and placed guidewire vessel sheath.The mild dissected target lesion was located in the non-calcified and non-tortuous right iliac artery.The physician advanced the guidewire and pig tail angiography catheter through the sheath to inferior vena cava to perform angiography.After an amplatz 5090 guidewire was placed as support a 7x80x120 epic vascular stent was advanced for treatment.During stent deployment the stent was displaced forwardly.Because the stent could not be constrained, it was then completely deployed but failed to be deployed in accurate location.The device was implanted in the lesion and was overlapped with other 7x100 innova stent to cover the lesion.There were no patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluation 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 and microscopic examination revealed no damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that stent migration occurred.The patient underwent abdominal aortography and iliac artery stenting.Vascular access was obtained via the femoral artery and placed guidewire vessel sheath.The mild dissected target lesion was located in the non-calcified and non-tortuous vessel.The physician advanced the guidewire and pig tail angiography catheter through the sheath to inferior vena cava to perform angiography.After an amplatz5090 guidewire was placed as support, a 7 x 80 x 120 epic vascular stent was advanced for treatment.During stent deployment, it was noticed that the stent was displaced forwardly.Because the stent could not be constrained, it was then completely deployed but failed to be deployed in accurate location.The device was implanted in the lesion and was overlapped with other 7x100 innova stent to cover the lesion.There were no patient complications 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: 11515381
• Report Number: 2134265-2021-03461
• Device Sequence Number: 4203771
• Product Code: NIO
• UDI-Device Identifier: 08714729805526
• UDI-Public: 08714729805526
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024492302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75