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

Model Number 20300

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

Event Description

It was reported that stent partially deployed and catheter entrapment on guidewire occurred.The target lesion was located in the femoral artery.A 7x40x75 epic stent was selected for treatment.The stent was properly flushed and placed over a 260cm non-boston scientific wire.However, it was noted that the device was stuck on the wire and was unable to move.When the delivery system was pulled back, it was noted that the stent was partially deployed.The wire and the stent delivery system were pulled back and the procedure was completed with a new epic stent.No patient complications were reported.

Event Description

It was reported that stent partially deployed and catheter entrapment on guidewire occurred.The target lesion was located in the femoral artery.A 7x40x75 epic stent was selected for treatment.The stent was properly flushed and placed over a 260cm non-boston scientific wire.However, it was noted that the device was stuck on the wire and was unable to move.When the delivery system was pulled back, it was noted that the stent was partially deployed.The wire and the stent delivery system were pulled back and the procedure was completed with a new epic stent.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system with an unknown 0.035 inch guidewire.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is no longer inside the sheath.There is buckling to the sheath 58cm from the strain relief.Microscopic examination revealed no additional damages.The lock is still in the manufactured position, but the sheath is no longer sitting on top of the proximal end of the tip.The device was x-ray and there were no additional damages seen.The guidewire could not be removed from the device.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EPIC
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12816811
• MDR Text Key: 281013546
• Report Number: 2134265-2021-13892
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0027347677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1