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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 Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that partial deployment occurred.Vascular access was obtained via contralateral and pedal approach.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right superficial femoral artery (sfa).A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.During deployment, normal force was used to turn the thumbwheel; however, only 70% of the stent deployed.The pull grip was used in an attempt to complete deployment.There were no kinks observed on the catheter.Difficulty was encountered during device removal, but the device was removed.The procedure was completed with another eluvia stent.There were no patient complications.
 
Event Description
It was reported that partial deployment occurred.Vascular access was obtained via contralateral and pedal approach.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right superficial femoral artery (sfa).A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.During deployment, normal force was used to turn the thumbwheel; however, only 70% of the stent deployed.The pull grip was used in an attempt to complete deployment.There were no kinks observed on the catheter.Difficulty was encountered during device removal, but the device was removed.The procedure was completed with another eluvia stent.There were no patient complications.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated 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 middle sheath 31.8cm from the distal end of the middle sheath.The stent is partially deployed and stretched approximately 5.7cm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The rack is fully deployed and is able to freely move.The handle was opened to verify if there are any additional damages inside.It was found that the middle sheath is no longer attached to the retainer.Inspection of the remainder of the device, revealed 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 Key10476823
MDR Text Key205113254
Report Number2134265-2020-12001
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876618
UDI-Public08714729876618
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 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/10/2021
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0024324997
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Date Manufacturer Received09/10/2020
Patient Sequence Number1
Treatment
GUIDE SHEATH: 7FR COOK ANSEL 45CM; GUIDE SHEATH: 7FR COOK ANSEL 45CM; GUIDEWIRE: TERUMO ADVANTAGE 0.035; GUIDEWIRE: TERUMO ADVANTAGE 0.035; GUIDE SHEATH: 7FR COOK ANSEL 45CM; GUIDEWIRE: TERUMO ADVANTAGE 0.035
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