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

Model Number	39200
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent foreshortening occurred.The patient presented with lower extremity arterial disease (lead).The 99% stenosed, 13 to 14cm in length, target lesion was located in the moderately tortuous and mildly calcified iliac vessel.After the 6f nonboston scientific (bsc) sheath was introduced and nonbsc guidewire crossed the lesion, a 12 x 40 x 120 epic vascular stent was advanced for treatment.However, during procedure, the stent was shortened and was unable to cover the lesion.Another 12 x 60 x 120 epic vascular stent was then placed, and the procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: epic vascular 12x40x120 was received for analysis.A visual examination found the stent of the device to have been fully deployed from the delivery system.The deployed stent was not returned for analysis as it was implanted inside the patient.A visual examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual inspection found no damage or issues with the handle of the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent foreshortening occurred.The patient presented with lower extremity arterial disease (lead).The 99% stenosed, 13-14cm in length, target lesion was located in the moderately tortuous and mildly calcified iliac vessel.After the 6f non-boston scientific (bsc) sheath was introduced and non-bsc guidewire crossed the lesion, a 12 x 40 x 120 epic vascular stent was advanced for treatment.However, during procedure, the stent was shortened and was unable to cover the lesion.Another 12 x 60 x 120 epic vascular stent was then placed, and the procedure was completed successfully.No patient complications were 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16409605
• Report Number: 2124215-2023-05952
• Device Sequence Number: 5378855
• Product Code: NIO
• UDI-Device Identifier: 08714729805144
• UDI-Public: 08714729805144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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 Expiration Date: 05/29/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022186940
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2018
• 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, JUPITER FC3 BOSTON.; GUIDEWIRE, JUPITER FC3 BOSTON.; INFLATION DEVICE, COMPAK.; INFLATION DEVICE, COMPAK.; INTRODUCER SHEATH, 6F DESTINATION TERUMO.; INTRODUCER SHEATH, 6F DESTINATION TERUMO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown