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

Model Number	39200
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial deployment occurred.During a procedure for percutaneous transhepatic biliary digital subtraction angiography (dsa) and seed stent implantation, this 10x80x120 epic vascular stent self expanding was crossed the lesion site along with v-18 guidewire.During the deployment process, the stent could not be deployed in the sheath.After it was removed, the stent deployed in the sheath.The stent and sheath were withdrawn together from the body and confirmed that the stent was partially deployed.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
E1 initial reporter facility name: the second affiliated hospital of pla air force medical university of chinese people's liberation army.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination found the stent of the device to be partially deployed on the delivery system.The device was successfully fully deployed the stent without issue.The distal end of the deployed stent was found to be damaged.A visual and tactile inspection found the inner sheath of the device to be severely kinked at more than one location including the same location as the stent when it was in position on the delivery system.A visual and tactile examination identified no issues with the tip and handle of the device.
Event or Problem Description
It was reported that stent partial deployment occurred.During a procedure for percutaneous transhepatic biliary digital subtraction angiography (dsa) and seed stent implantation, this 10x80x120 epic vascular stent self expanding was crossed the lesion site along with v-18 guidewire.During the deployment process, the stent could not be deployed in the sheath.After it was removed, the stent deployed in the sheath.The stent and sheath were withdrawn together from the body and confirmed that the stent was partially deployed.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20231925
• Report Number: 2124215-2024-57100
• Device Sequence Number: 18302170
• Product Code: NIO
• UDI-Device Identifier: 08714729805083
• UDI-Public: 08714729805083
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 0032726192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V-18 CONTROL WIRE; GUIDEWIRE: V-18 CONTROL WIRE
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 58 KG