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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC Back to Search Results
Model Number 20300
Device Problems Difficult to Insert (1316); Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported that the stent started to migrate off the delivery system.An 8mm x 40mm x 75cm epic stent was selected for use in an angioplasty and stenting procedure to treat an iliac occlusion.However, during the procedure, the device was unable to be inserted into the sheath because the stent started to migrate off the delivery system.The yellow safety lock remained untouched.The procedure was completed using an alternative stent.There were no patient complications reported.
 
Event Description
It was reported that the stent started to migrate off the delivery system.An 8mm x 40mm x 75cm epic stent was selected for use in an angioplasty and stenting procedure to treat an iliac occlusion.However, during the procedure, the device was unable to be inserted into the sheath because the stent started to migrate off the delivery system.The yellow safety lock remained untouched.The procedure was completed using an alternative stent.There were no patient complications reported.
 
Manufacturer Narrative
Device eval by manufacturer: the device was received with the stent partially deployed on the delivery system.No issues were noted with the stent.The device could not be advance through a sheath due to the partial deployment.A visual examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the sheath of the device.A visual examination identified no issues or damage to the handle of the device.The safety lock was in place on the rack of the device.
 
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Brand Name
EPIC
Type of Device
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 Key18703558
MDR Text Key335745696
Report Number2124215-2024-08141
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20300
Device Catalogue Number20300
Device Lot Number0032670495
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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