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 24653
Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2022
Event Type  malfunction  
Event Description
It was reported that partial deployment occurred, and the stent stretched.Vascular access was gained via contralateral approach.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery (sfa).A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.The lesion was predilated.Resistance was felt during advancement of the eluvia.The thumbwheel was turned around a few centimeters deploying approximately 11cm of the stent with 1cm remaining.The shaft was pulled, and the stent stretched a little, but there was no change in shape.The stent ultimately deployed, and post dilation was performed.The guidewire was stuck in the eluvia catheter shaft; therefore, the guidewire and the delivery system were removed together as one unit.No additional treatment was performed.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the sheath is kinked at the nosecone.The pull rack is separated at the handle.The proximal section of the separated pull rack did not return for analysis.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.There is evidence the device was used contrary to product labeling per the instructions for use (ifu).The ifu states: a stiff 0.035 in guidewire is strongly recommended for deployment of the stent, especially for tortuous anatomy and contralateral approaches.Use of undersized guidewires may lead to insufficient support of the device which can compromise stent delivery.The use of an undersized guidewire during deployment would lead to insufficient support and cause the proximal inner to prolapse.Prolapsing of the proximal inner would cause deployment issues and damage to the stent if the stent did not fully deploy when the device is pulled out.
 
Event Description
It was reported that partial deployment occurred, and the stent stretched.Vascular access was gained via contralateral approach.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery (sfa).A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.The lesion was predilated.Resistance was felt during advancement of the eluvia.The thumbwheel was turned around a few centimeters deploying approximately 11cm of the stent with 1cm remaining.The shaft was pulled, and the stent stretched a little, but there was no change in shape.The stent ultimately deployed, and post dilation was performed.The guidewire was stuck in the eluvia catheter shaft; therefore, the guidewire and the delivery system were removed together as one unit.No additional treatment was performed.There were no patient complications.
 
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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16027389
MDR Text Key306410476
Report Number2124215-2022-52684
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/24/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029046063
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-