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

Model Number	39200
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent difficulty to position occurred.Patient underwent a shunt percutaneous transluminal angioplasty.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified graft and anastomosis.Stent implantation was not indicated but still performed after a 6x100x75 mustang balloon catheter was performed for pre-dilation.An 8x40x75 epic stent was initially implanted.After deployment, it appeared to be skipping as if it was being pushed.The physician had used this device before.An 8x60x75 epic stent was attempted to be implanted to cover the lesion, but the same event occurred where it seemed to be skipping.Per method of use, the stent must be set aside when positioning to avoid resistance on the shaft.This was attempted, however, there was skipping after deployment despite an overlap of more than 2cm on the graft.Approximate 4cm appeared to be skipping and it came out ahead of the first 4cm of the epic.The lesion was not covered, and the procedure was discontinued.There were no complications reported, and the patient's status 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: 18740570
• Report Number: 2124215-2024-09451
• Device Sequence Number: 15051916
• Product Code: NIO
• UDI-Device Identifier: 08714729805694
• UDI-Public: 08714729805694
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: 0032452607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPIC 8X60 75CM.; MOSQUITO 6F 3CM.; MUSTANG 6X100.; RADIFOCUS 180CM.
• Patient Age: 65 YR
• Patient Sex: Male