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

Model Number	39202
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 04-apr-2023.It was reported that device difficult to cross occurred.The 70-80 calcified lesion was located in the iliac artery.A 10x100x75 epic vascular stent self expanding was advanced for treatment during the procedure, the device could not pass the angle of the lesion due to the resistance.No patient complications were reported, and the patient was fine.However, returned device analysis revealed stent partially deployed.It was further reported that the stent was partially deployed during withdrawal.
Additional Manufacturer Narrative
Device evaluated by mfr.: the epic vascular was returned for analysis.The device was received with the stent partially deployed on the delivery system.It is not known when or why deployment occurred.A visual examination found no kinks or damage to the sheath of the device.A visual and tactile examination identified no issues with the tip of the device.No damage or issues were noted with the handle of the device.The safety clip had been removed from the rack.

• 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: 19228473
• Report Number: 2124215-2024-23708
• Device Sequence Number: 6834198
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: 08714729805113
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0028436828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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