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 Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 01/30/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event- age at time of event: 18 years or older.Initial reporter state: (b)(6).
 
Event Description
It was reported that the stent partially deployed and fractured.Vascular access was obtained via the left upper arm.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).After passing with a non-bsc 0.014" guidewire and inflating a non-bsc 6x80 balloon, a dissection occurred.The guidewire was changed to a 0.035" guidewire and a 6x80, 130cm eluvia drug-eluting vascular stent system was implanted.After placement of the eluvia stent, the dissection spread to the distal side of the stent.A 6x120, 130cm eluvia drug-eluting vascular stent system was implanted.The thumbwheel spins as the stent was deployed approximately one third.The pull grip was pulled out, but the stent did not deploy any more.The physician disassembled the handle and tried to deploy the stent, but could not deploy it.After an attempt was made to pull the eluvia into the non-bsc 6fr introducer sheath with the whole system together, but the stent broke.One third of the stent was implanted in the vessel, it stretched a few centimeters and broke.Several struts of the stent on the shaft side were protruding from the shaft, and the stent could not be pulled into the sheath.The physician pulled it slowly to the puncture site as it was, then the puncture site was cut open by a vascular surgeon to remove the entire system.After that, an eluvia 6x120 was placed in the broken stent.Good blood flow was confirmed by angio and the procedure was completed.There were no further patient complications.
 
Manufacturer Narrative
A2: age at time of event- age at time of event: 18 years or older.E1: initial reporter state- (b)(6).Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system inside of a terumo guide catheter.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle and thumbwheel are missing.The stent is partially deployed from the middle sheath.The exposed portion of the stent is stretched and there is a separation.The distal section of the stent including the radiopaque marker is missing.The entire stent measures approximately 94mm long.The proximal inner is kinked 3mm from the retainer and the middle sheath is no longer attached to the middle sheath.The inner liner is kinked 7mm and 2mm from the proximal end of the tip.Microscopic examination revealed marks on the proximal end of the tip.Four photos were provided by the customer.In the photos it is possible to see all the damages that were found during analysis.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 the left upper arm.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).After passing with a non-bsc 0.014" guidewire and inflating a non-bsc 6x80 balloon, a dissection occurred.The guidewire was changed to a 0.035" guidewire and a 6x80, 130cm eluvia drug-eluting vascular stent system was implanted.After placement of the eluvia stent, the dissection spread to the distal side of the stent.A 6x120, 130cm eluvia drug-eluting vascular stent system was implanted.The thumbwheel spins as the stent was deployed approximately one third.The pull grip was pulled out, but the stent did not deploy any more.The physician disassembled the handle and tried to deploy the stent, but could not deploy it.After an attempt was made to pull the eluvia into the non-bsc 6fr introducer sheath with the whole system together, but the stent broke.One third of the stent was implanted in the vessel, it stretched a few centimeters and broke.Several struts of the stent on the shaft side were protruding from the shaft, and the stent could not be pulled into the sheath.The physician pulled it slowly to the puncture site as it was, then the puncture site was cut open by a vascular surgeon to remove the entire system.After that, an eluvia 6x120 was placed in the broken stent.Good blood flow was confirmed by angio and the procedure was completed.There were no further 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
MDR Report Key9732445
MDR Text Key180413452
Report Number2134265-2020-01721
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 03/12/2020
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 Date06/17/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0024031624
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2020
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/20/2020
Supplement Dates Manufacturer Received02/21/2020
Supplement Dates FDA Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALLOON: JADE6X80; BALLOON: JADE6X80; GUIDEWIRE: 0.014" COMMAND; GUIDEWIRE: 0.014" COMMAND; GUIDEWIRE: 0.035" RADIFOCUS; GUIDEWIRE: 0.035" RADIFOCUS; INTRODUCER SHEATH: DESTINATION6FR90CM; INTRODUCER SHEATH: DESTINATION6FR90CM
Patient Outcome(s) Required Intervention;
-
-