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

Model Number	39200
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 09nov2023.It was reported that the shaft was kinked and damaged.After unpacking an 8x60x120 epic vascular stent, it was observed that the shaft catheter was kinked and damaged and could not be implanted.The procedure was then completed with a different device.There were no patient complications reported, and the patient was stable post-procedure.However, returned device analysis revealed that stent was partially deployed.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: epic vascular 8x60x120, was received for analysis.The device was received with the safety clip removed and the stent partially deployed on the delivery system.No issues were noted with the stent.A visual examination found no kinks or damage to the outer sheath of the device.A visual inspection found the inner sheath of the device to be kinked at approximately 3mm proximal of the tip bond.This type of damage is consistent with excessive force being applied to 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 lock 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: 18222541
• Report Number: 2124215-2023-63787
• Device Sequence Number: 12442810
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: 08714729805687
• 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
• Report Date (Section B): 11/28/2023

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: 0030880764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG