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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 Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Event Description
It was reported that the stent stretched.A 6mm x 120mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty (pta) procedure in the right superficial femoral artery (sfa).The 100% stenosed target lesion was severely calcified and located in severely tortuous anatomy.A non-boston scientific introducer sheath, a non-boston scientific guidewire, a 6mm x 40mm x 80cm sterling balloon catheter, and a non-boston scientific inflation device were also used in this procedure.During the procedure, the eluvia's thumbwheel became stiff and hard when attempting to deploy the stent.It required high force to turn the thumbwheel, but eventually the stent fully deployed.The stent was stretched slightly as a result of this event.The procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
Device eval by mfr: 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 a kink to the outer sheath at the nosecone.There is a kink to the inner liner 13.5cm from the tip.Microscopic examination revealed no additional damages.The handle was disassembled, and no additional damages were found.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent stretched.A 6mm x 120mm x 130cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty (pta) procedure in the right superficial femoral artery (sfa).The 100% stenosed target lesion was severely calcified and located in severely tortuous anatomy.A non-boston scientific introducer sheath, a non-boston scientific guidewire, a 6mm x 40mm x 80cm sterling balloon catheter, and a non-boston scientific inflation device were also used in this procedure.During the procedure, the eluvia's thumbwheel became stiff and hard when attempting to deploy the stent.It required high force to turn the thumbwheel, but eventually the stent fully deployed.The stent was stretched slightly as a result of this event.The procedure was completed.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 Key10983986
MDR Text Key220682846
Report Number2134265-2020-17299
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
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/17/2022
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0025836833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASAHI HALBERD GUIDEWIRE; ASAHI HALBERD GUIDEWIRE; MEDTRONIC EVEREST INFLATION DEVICE; MEDTRONIC EVEREST INFLATION DEVICE; TERUMO DESTINATION SHEATH; TERUMO DESTINATION SHEATH; ASAHI HALBERD GUIDEWIRE; MEDTRONIC EVEREST INFLATION DEVICE; TERUMO DESTINATION SHEATH
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