|
Model Number 26927 |
Device Problems
Entrapment of Device (1212); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/18/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the stent partially deployed and stretched.A 6 x 200 x 130 innova self expanding stent was selected for use in a stenting procedure.A contralateral approach was used to access the 90% stenosed superficial femoral artery that was severely calcified and severely tortuous.The lesion was pre-dilated with a 5 x 220 sterling balloon.During deployment of the innova device, the stent would not fully deploy.Elevated force was required to turn the thumbwheel and then it stopped working.Only 60% of the stent was deployed.The pull grip was pulled in an attempt to deploy the last 100mm.Some of the stent deployed, but not all of it.The blue handle was pulled harder, and the stent eventually deployed but elongated.The stent stretched approximately 20mm.After implanting the stent, the delivery system became stuck on the 018 non-boston scientific guidewire.The handle was disassembled in order to pull it off the guidewire, but this was unsuccessful.External to the patient, the physician then used a scalpel to cut away the proximal section of the delivery system to expose the guidewire and pull the distal part of the delivery system off the guidewire.The implanted stent was fully expanded and post dilated.The procedure was successfully completed.No patient complications were reported.
|
|
Event Description
|
It was reported that the stent partially deployed and stretched.A 6 x 200 x 130 innova self expanding stent was selected for use in a stenting procedure.A contralateral approach was used to access the 90% stenosed superficial femoral artery that was severely calcified and severely tortuous.The lesion was pre-dilated with a 5 x 220 sterling balloon.During deployment of the innova device, the stent would not fully deploy.Elevated force was required to turn the thumbwheel and then it stopped working.Only 60% of the stent was deployed.The pull grip was pulled in an attempt to deploy the last 100mm.Some of the stent deployed, but not all of it.The blue handle was pulled harder, and the stent eventually deployed but elongated.The stent stretched approximately 20mm.After implanting the stent, the delivery system became stuck on the 018 non-boston scientific guidewire.The handle was disassembled in order to pull it off the guidewire, but this was unsuccessful.External to the patient, the physician then used a scalpel to cut away the proximal section of the delivery system to expose the guidewire and pull the distal part of the delivery system off the guidewire.The implanted stent was fully expanded and post dilated.The procedure was successfully completed.No patient complications were reported.
|
|
Manufacturer Narrative
|
Device eval by manufacturer: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the handle was partially open.There was multiple buckling to the outer sheath.There were multiple kinks along the outer sheath.The proximal inner was prolapsed.There were multiple kinks along the proximal inner.The middle sheath was separated 97.5cm from the distal end of the middle sheath.The outer sheath was separated 3.5cm from the nosecone.The proximal inner was separated 77.1cm from the distal end.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue, stent deformation, difficulty removing, and guidewire entrapment.
|
|
Search Alerts/Recalls
|
|
|