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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24657
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Event Description
It was reported that the shaft of the device broke.A 6x40x130 drug eluting self-expanding stent was selected for use in a peripheral leg intervention.During the procedure, the inner liner of the stent system detached from the rest of the delivery system.The stent was successfully delivered.The delivery system was successfully removed, however, it was in two pieces.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed the pull shaft had separated, a kink to the outer sheath at the nosecone and a kink on the middle sheath.The outer sheath is kinked 6.7 cm from the retainer.The inner liner is kinked 7.7 cm from the tip.The pull rack is separated 4.2 cm from the distal end of the rack.Microscopic examination revealed no additional damages.The handle was opened, and no additional damages were found.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the shaft of the device broke.A 6x40x130 drug eluting self-expanding stent was selected for use in a peripheral leg intervention.During the procedure, the inner liner of the stent system detached from the rest of the delivery system.The stent was successfully delivered.The delivery system was successfully removed, however, it was in two pieces.No patient complications were reported.
 
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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12059194
MDR Text Key258337844
Report Number2134265-2021-08052
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876571
UDI-Public08714729876571
Combination Product (y/n)Y
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/07/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0026901167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Date Manufacturer Received07/22/2021
Patient Sequence Number1
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