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

Model Number	39200
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the bilateral iliac artery.After balloon pre-dilation, a 9x40x120 epic vascular self-expanding stent was advanced for treatment.The stent was delivered at the designated position; however, the stent release system was found to be stuck and could not be deployed normally.The stent was pushed out after removal and found damaged.The physician tried to deploy the stent in vitro, however, it was deformed since it became stuck.The procedure was completed with another of the same device.No complications were reported, and the patent was stable.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the bilateral iliac artery.After balloon pre-dilation, a 9x40x120 epic vascular self-expanding stent was advanced for treatment.The stent was delivered at the designated position; however, the stent release system was found to be stuck and could not be deployed normally.The stent was pushed out after removal and found damaged.The physician tried to deploy the stent in vitro, however, it was deformed since it became stuck.The procedure was completed with another of the same device.No complications were reported, and the patent was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.It was received with the stent already deployed from the delivery system.The deployed stent was noted to be damaged.A visual examination identified no issues with the tip of the device.A visual and tactile examination found multiple inner sheath kinks.A visual examination identified no issues or damage to the handle of the device.

• 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: 19297832
• Report Number: 2124215-2024-26684
• Device Sequence Number: 6883276
• Product Code: NIO
• UDI-Device Identifier: 08714729805786
• UDI-Public: 08714729805786
• 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): 06/06/2024

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 Expiration Date: 04/23/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0023692649
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2019
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 76 KG