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 INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY
  • 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 INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26924
Device Problems Entrapment of Device (1212); Premature Activation (1484)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Event Description
It was reported that the device became stuck on the guidewire and partially deployed outside the patient.An innova was selected for use in a stenting procedure to treat a dissection flap in the superficial femoral artery.Upon placing the stent on a 0.035 inch stiff zipwire guidewire, the device became stuck.An attempt was made to take the stent off the wire to re-flush, but in doing so, the stent partially deployed outside the body.The stent never entered the body.Eventually, the device was able to be removed from the wire.The procedure was completed with a different stent.No patient complications were reported.
 
Event Description
It was reported that the device became stuck on the guidewire and partially deployed outside the patient.An innova was selected for use in a stenting procedure to treat a dissection flap in the superficial femoral artery.Upon placing the stent on a 0.035 inch stiff zipwire guidewire, the device became stuck.An attempt was made to take the stent off the wire to re-flush, but in doing so, the stent partially deployed outside the body.The stent never entered the body.Eventually, the device was able to be removed from the wire.The procedure was completed with a different stent.No patient complications were reported.
 
Event Description
It was reported that the device became stuck on the guidewire and partially deployed outside the patient.An innova was selected for use in a stenting procedure to treat a dissection flap in the superficial femoral artery.Upon placing the stent on a 0.035 inch stiff zipwire guidewire, the device became stuck.An attempt was made to take the stent off the wire to re-flush, but in doing so, the stent partially deployed outside the body.The stent never entered the body.Eventually, the device was able to be removed from the wire.The procedure was completed with a different stent.No patient complications were reported.
 
Manufacturer Narrative
H3: device eval by manufacturer: the innova self-expanding stent system was returned to boston scientific for analysis.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed approximately 7mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock was missing.The pull rack was still in the manufactured position.This suggests that the thumbwheel was not accidently used to deploy the stent.The information provided also indicates that the thumbwheel lock was still on the device.It is likely that something else caused the stent to partially deploy.Kinks to the sheath usually occur when the device is advancing along the wire and is met with some resistance.The information provided indicates that the wire was taken out after it got stuck which also suggest that the interactions with the guidewire likely contributed to the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INNOVA VASCULAR
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11108327
MDR Text Key224787985
Report Number2134265-2020-18404
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729874096
UDI-Public08714729874096
Combination Product (y/n)N
PMA/PMN Number
P140028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0026156850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Initial Date Manufacturer Received 12/15/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received12/15/2020
02/11/2021
Supplement Dates FDA Received01/05/2021
03/01/2021
Patient Sequence Number1
-
-