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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC Back to Search Results
Model Number 39200
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The target lesion was located in anastomosis of fistula.A 6x60x75 epic vascular stent was selected for use.However, the distal stent struts where the markers lie are slightly peeled away from the catheter prior to placement into the sheath.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed 1mm from the distal end of the middle sheath.There is a kink to the sheath 58.5cm from the nosecone.Microscopic examination revealed that the sheath is flattened at the distal end.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in anastomosis of fistula.A 6x60x75 epic vascular stent was selected for use.However, the distal stent struts where the markers lie are slightly peeled away from the catheter prior to placement into the sheath.The procedure was completed with another of the same device.There were no patient complications reported.
 
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Brand Name
EPIC VASCULAR
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11013105
MDR Text Key221806912
Report Number2134265-2020-17820
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805335
UDI-Public08714729805335
Combination Product (y/n)N
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/22/2021
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
Device Operator Health Professional
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0025933746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received01/14/2021
Supplement Dates FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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