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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2023
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 8 x 80 x 120 epic vascular stent was selected for use.However, after unpacking, it was noticed that there was a space at the tip of the stent.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
 
Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter phone: (b)(6).
 
Event Description
It was reported that stent damage occurred.A 8 x 80 x 120 epic vascular stent was selected for use.However, after unpacking, it was noticed that there was a space at the tip of the stent.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
 
Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter phone: (b)(6) epic vascular 8x80x120 was received for analysis.The device was received with the stent partially deployed on the delivery system.No issues were noted with the stent.Blood and possible body matter was identified on the device.A visual examination identified no issues with the tip of the device.A visual and tactile examination found the sheath of the device to be damaged.This type of damage is consistent with excessive force being applied to 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 VASCULAR
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 Key17482572
MDR Text Key320719131
Report Number2124215-2023-39425
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805724
UDI-Public08714729805724
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2023
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 Number0030326335
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2022
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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