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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 Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2020
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.A 6x40x130 eluvia drug-eluting vascular stent system was selected for use for an angioplasty and stenting procedure in the superficial femoral artery (sfa).During preparation, it was observed that the stent was just barely exposed at the tapered nose cone as if it was starting to deploy.However, the yellow safety was still intact on the deployment wheel.The stent was never introduced into the sheath or patient body.The procedure was completed with a different stent and there were no patient complications reported.
 
Event Description
It was reported that the stent inadvertently deployed.A 6x40x130 eluvia drug-eluting vascular stent system was selected for use for an angioplasty and stenting procedure in the superficial femoral artery (sfa).During preparation, it was observed that the stent was just barely exposed at the tapered nose cone as if it was starting to deploy.However, the yellow safety was still intact on the deployment wheel.The stent was never introduced into the sheath or patient body.The procedure was completed with a different stent and there were no patient complications reported.
 
Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 23020071.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the sheath at the nosecone.The stent is partially deployed 2mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured position.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key10800790
MDR Text Key215041843
Report Number2134265-2020-15416
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876571
UDI-Public08714729876571
Combination Product (y/n)N
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/19/2020
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 Expiration Date05/07/2020
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0023020071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Initial Date Manufacturer Received 10/19/2020
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer Received11/17/2020
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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