Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24657
Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2020
Event Type  Injury  
Event Description
It was reported the stent partially deployed, stretched, and fractured.Atherectomy and ballooning with non-boston scientific devices of the right peroneal artery and right superficial artery (sfa) was performed.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use and was advanced over a non-boston scientific guidewire.Deployment of the device was initiated.Only the distal half of the stent was deployed.The eluvia catheter was pulled back while turning the thumbwheel.The remaining proximal half deployed.Stent elongation and fracture occurred.Half of the stent was in the distal sfa and the other half was 120mm superior to the deployment location.A 6x100x130 innova was implanted to connect the two eluvia stent fragments.The procedure was successfully completed and the patient was in good health.
 
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 pull rack is separated, and the proximal end is missing.There is approximately 7mm of the rack sticking out from the handle.Microscopic examination revealed no additional damages.X-ray of the handle showed that the proximal inner is prolapsed.The stent was deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis could not confirm the reported stent deformation but did find damage that would have contributed to deployment issues.
 
Event Description
It was reported the stent partially deployed, stretched, and fractured.Atherectomy and ballooning with non-boston scientific devices of the right peroneal artery and right superficial artery (sfa) was performed.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use and was advanced over a non-boston scientific guidewire.Deployment of the device was initiated.Only the distal half of the stent was deployed.The eluvia catheter was pulled back while turning the thumbwheel.The remaining proximal half deployed.Stent elongation and fracture occurred.Half of the stent was in the distal sfa and the other half was 120mm superior to the deployment location.A 6x100x130 innova was implanted to connect the two eluvia stent fragments.The procedure was successfully completed and the patient was in good health.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10843899
MDR Text Key216362321
Report Number2134265-2020-15883
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2021
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0024634470
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Date Manufacturer Received12/10/2020
Patient Sequence Number1
Treatment
CSI VIPER WIRE; CSI VIPER WIRE; CSI VIPER WIRE
Patient Outcome(s) Required Intervention;
Patient Age86 YR
-
-