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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 Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 10/10/2019
Event Type  Injury  
Event Description
It was reported that the stent partially deployed and stretched requiring additional intervention.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous right superficial femoral artery (sfa).A 7x120x130 eluvia drug-eluting vascular stent system was selected for use.Following pre-dilation, the stent was advanced contralaterally over a non-bsc guidewire and stent deployment was initiated.The stent was deployed about 80% with the thumbwheel, then the physician tried to use the pull grip.The stent could not be deployed with the thumbwheel or the pull grip.The physician stated that it felt like something was stuck.Eventually it was able to be deployed by moving the shaft back and forth.The stent became stretched due to this issue.Another eluvia drug-eluting vascular stent system was additionally placed in the extended part of the stretched stent.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by mfr: 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 and a kink to the middle sheath 28mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-ray and the proximal inner can be seen prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent partially deployed and stretched requiring additional intervention.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous right superficial femoral artery (sfa).A 7x120x130 eluvia drug-eluting vascular stent system was selected for use.Following pre-dilation, the stent was advanced contralaterally over a non-bsc guidewire and stent deployment was initiated.The stent was deployed about 80% with the thumbwheel, then the physician tried to use the pull grip.The stent could not be deployed with the thumbwheel or the pull grip.The physician stated that it felt like something was stuck.Eventually it was able to be deployed by moving the shaft back and forth.The stent became stretched due to this issue.Another eluvia drug-eluting vascular stent system was additionally placed in the extended part of the stretched stent.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 Key9260932
MDR Text Key164469561
Report Number2134265-2019-13191
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,foreig
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/29/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0023436395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DESTINATION 6F INTRODUCER SHEATH; DESTINATION 6F INTRODUCER SHEATH; SHIDEN HP BALLOON CATHETER; SHIDEN HP BALLOON CATHETER; VASSALO NS3 GUIDEWIRE; VASSALO NS3 GUIDEWIRE; DESTINATION 6F INTRODUCER SHEATH; SHIDEN HP BALLOON CATHETER; VASSALO NS3 GUIDEWIRE
Patient Outcome(s) Required Intervention;
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