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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 24653
Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult or Delayed Activation (2577); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2020
Event Type  malfunction  
Event Description
It was reported that the device became stuck on the wire.A 7x120x130 eluvia self expanding drug eluting stent was selected for use to treat peripheral artery disease (pad) in the right superficial femoral artery (sfa).The 95% stenosed lesion was severe tortuosity and 90% stenosed after predilation.During the procedure, the stent was successfully advanced via contralateral approach over a.014 non-bsc guidewire.The thumbwheel was very hard to rotate and the pull grip was used to deploy the stent.Once the stent was placed, the stent delivery system became stuck on the non-bsc guidewire.The delivery system and the wire were removed successfully from the patient and a new guidewire and eluvia stent were used to complete the procedure.It was noted that the catheter was kinked on the shaft near the nosecone.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer.Returned product consisted of an eluvia self-expanding stent system with a 0.014 guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The proximal inner is prolapsed inside the handle.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the device became stuck on the wire.A 7x120x130 eluvia self expanding drug eluting stent was selected for use to treat peripheral artery disease (pad) in the right superficial femoral artery (sfa).The 95% stenosed lesion was severe tortuosity and 90% stenosed after predilation.During the procedure, the stent was successfully advanced via contralateral approach over a.014 non-bsc guidewire.The thumbwheel was very hard to rotate and the pull grip was used to deploy the stent.Once the stent was placed, the stent delivery system became stuck on the non-bsc guidewire.The delivery system and the wire were removed successfully from the patient and a new guidewire and eluvia stent were used to complete the procedure.It was noted that the catheter was kinked on the shaft near the nosecone.No patient complications were reported.
 
Event Description
It was reported that the device became stuck on the wire.A 7x120x130 eluvia self expanding drug eluting stent was selected for use to treat peripheral artery disease (pad) in the right superficial femoral artery (sfa).The 95% stenosed lesion was severe tortuosity and 90% stenosed after predilation.During the procedure, the stent was successfully advanced via contralateral approach over a.014 non-bsc guidewire.The thumbwheel was very hard to rotate and the pull grip was used to deploy the stent.Once the stent was placed, the stent delivery system became stuck on the non-bsc guidewire.The delivery system and the wire were removed successfully from the patient and a new guidewire and eluvia stent were used to complete the procedure.It was noted that the catheter was kinked on the shaft near the nosecone.No patient complications were reported.
 
Manufacturer Narrative
D4: lot number: initially reported 0024502793 and was updated to 0024528226.
 
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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 Key10092062
MDR Text Key192219834
Report Number2134265-2020-06995
Device Sequence Number1
Product Code NIU
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,distri
Type of Report Initial,Followup,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/03/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0024528226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Date Manufacturer Received07/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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