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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 Break (1069); Fracture (1260); Activation, Positioning or Separation Problem (2906)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/06/2020
Event Type  Injury  
Event Description
It was reported that the stent partially deployed and fractured.Vascular access was obtained via contralateral approach.The greater than 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.A filter was placed below the lesion with high resistance prior to balloon dilatation and stent deployment.The lesion was pre-dilated.During deployment after use of the thumbwheel, the pull grip was extended to its max length and broke.About a quarter of the stent was deployed into the patient when the mechanism failed.The stent was pulled into the sheath; however the stent broke.The quarter of the stent that was deployed was left inside the patient and covered with a separate stent.The other part of the undeployed stent was successfully pulled out of the patient.The procedure was completed as planned and the patients status is fine.There were no patient complications.
 
Manufacturer Narrative
Device analysis 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 that the stent is partially deployed 4.5cm from the distal end of the middle sheath.The stent is stretched and separated.The distal end is missing.The total length of the stent is approximately 10.1cm long.There is a kink to the outer sheath at the nosecone.There is multiple minor buckling to the outer sheath and middle sheath.Microscopic examination revealed no additional damages.The rack is fully deployed and can 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.
 
Event Description
It was reported that the stent partially deployed and fractured.Vascular access was obtained via contralateral approach.The greater than 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.A filter was placed below the lesion with high resistance prior to balloon dilatation and stent deployment.The lesion was pre-dilated.During deployment after use of the thumbwheel, the pull grip was extended to its max length and broke.About a quarter of the stent was deployed into the patient when the mechanism failed.The stent was pulled into the sheath; however the stent broke.The quarter of the stent that was deployed was left inside the patient and covered with a separate stent.The other part of the undeployed stent was successfully pulled out of the patient.The procedure was completed as planned and the patients status is fine.There were no patient complications.
 
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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 Key10449676
MDR Text Key204242712
Report Number2134265-2020-11608
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 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2021
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0024298965
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Initial Date Manufacturer Received 08/06/2020
Initial Date FDA Received08/25/2020
Supplement Dates Manufacturer Received09/10/2020
Supplement Dates FDA Received09/23/2020
Patient Sequence Number1
Treatment
GUIDE SHEATH: 6 FRENCH; GUIDE SHEATH: 6 FRENCH; GUIDEWIRE: .014 SPIDER FX FILTER; GUIDEWIRE: .014 SPIDER FX FILTER; GUIDE SHEATH: 6 FRENCH; GUIDEWIRE: .014 SPIDER FX FILTER
Patient Outcome(s) Required Intervention;
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