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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported that tip detachment occurred.A 9x40x75 epic vascular stent was selected for use.However, during preparation, it was noted that the tip of the device broke off before loading onto the wire.The stent was never inserted into patient.The procedure was completed wit another epic stent of the same size.No patient complications were reported.
 
Event Description
It was reported that tip detachment occurred.A 9x40x75 epic vascular stent was selected for use.However, during preparation, it was noted that the tip of the device broke off before loading onto the wire.The stent was never inserted into patient.The procedure was completed wit another epic stent of the same size.No patient complications were 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 5mm from the sheath.The inner liner is kinked 19mm and 25mm from the tip.Microscopic examination revealed no additional damages.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks and partial deploy were attributable to failure to follow instructions.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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
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 Key12804902
MDR Text Key280960531
Report Number2134265-2021-13861
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805793
UDI-Public08714729805793
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2021
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 Number0027680092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2021
Initial Date FDA Received11/12/2021
Supplement Dates Manufacturer Received11/18/2021
Supplement Dates FDA Received11/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2021
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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