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

Model Number	39200
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that stent migration occurred.The 50% stenosed target lesion was located in the moderately tortuous left subclavian artery.A non-boston scientific sheath was guided proximally to the left subclavian artery lesion by left brachial artery puncture.Since the stenosis rate was mild, a 10x40x75mm epic stent was deployed in left subclavian artery without predilation.However, angiography after implantation showed that the distal end of the stent had protruded into the inferior aortic arch.A 9fr sheath was guided from the right femoral artery to the proximal part of the stent, and the stent was pulled in with a snare to the right common iliac artery.It was planned to be removed through an open wound, but due to a drop in blood pressure, it was decided to move the patient from the angiography room to the operating room after a computerized tomography (ct) scan to perform the procedure.After coil embolization of the posterior pancreatic duodenal artery due to bleeding in the abdominal cavity on the ct scan, the physician suggested that an open wound removal would be difficult, so an apposition was perform with a stent graft and completed the procedure.The bleeding is not related to the epic.The patient was stable and under observation as well as recuperating in intensive care unit.The attending physician informed that the cause of the patient's hypotension was a possible vascular perforation due to the 0.035 inch non-boston scientific guidewire migrated into the celiac artery when guiding the 9fr sheath.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).B5: describe event or problem- corrections to information previously reported.H6: device code corrected from migration to positioning problem.
Event or Problem Description
It was reported that stent migration occurred.The 50% stenosed target lesion was located in the moderately tortuous left subclavian artery.A non-boston scientific sheath was guided proximally to the left subclavian artery lesion by left brachial artery puncture.Since the stenosis rate was mild, a 10x40x75mm epic stent was deployed in left subclavian artery without predilation.However, angiography after implantation showed that the distal end of the stent had protruded into the inferior aortic arch.A 9fr sheath was guided from the right femoral artery to the proximal part of the stent, and the stent was pulled in with a snare to the right common iliac artery.It was planned to be removed through an open wound, but due to a drop in blood pressure, it was decided to move the patient from the angiography room to the operating room after a computerized tomography (ct) scan to perform the procedure.After coil embolization of the posterior pancreatic duodenal artery due to bleeding in the abdominal cavity on the ct scan, the physician suggested that an open wound removal would be difficult, so an apposition was perform with a stent graft and completed the procedure.The bleeding is not related to the epic.The patient was stable and under observation as well as recuperating in intensive care unit.The attending physician informed that the cause of the patient's hypotension was a possible vascular perforation due to the 0.035 inch non-boston scientific guidewire migrated into the celiac artery when guiding the 9fr sheath.It was further reported that the stent moved from the target site during deployment and not after stent implantation as what was previously reported.

• 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 johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15391718
• Report Number: 2124215-2022-31999
• Device Sequence Number: 20382884
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: 08714729805014
• 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): 09/29/2022

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 Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0028704153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown