|
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); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
|
| Patient Problem
No Consequences Or Impact To Patient (2199)
|
| Event Date 05/15/2019 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
Device is a combination device.(b)(6).
|
| |
|
Event Description
|
|
It was reported that there was difficulty removing the device from the lesion, shaft became stuck on the guidewire, and the tip became separated from the stent delivery system.A 6x120, 130cm eluvia drug-eluting vascular stent system and a 6x80, 130cm of the same device were selected for a percutaneous transluminal angioplasty procedure in the patient's superficial femoral artery (sfa).The lesion was moderately tortuous, mildly calcified, and 90% stenosed.The physician used an ipsilateral approach.The first stent was successfully placed in the sfa.After deployment, the inner shaft and tip of the stent delivery system (sds) became detached without the physician realizing it.There had been difficulty removing the system, so when it was pulled, the tip was believed to have became separated.It was after the second eluvia was successfully deployed in the sfa that the detachment was noted.The second eluvia had been loaded on the guidewire without removing the detached distal tip of the first device.When catching was felt during post dilatation, the physician noted the detachment.The sds was stuck with the guidewire, and it was difficult to remove from the lesion.The physician planned to clamp the guidewire so that it would remain in the patient, and remove only the eluvia device with forceps, but the guidewire and eluvia were inadvertently pinched together so the proximal sds and the wire were pulled out of the body together leaving the inner shaft and tip.The blue outer shaft of the sds was removed from the yellow shaft during the use of the forceps.The tips of the two devices were removed from the sheath, stuck on the guidewire.The first shaft/tip was not stuck, but was not able to be removed due to the second device being stuck.Once removed from the body, it was noted that it was difficult to distinguish the device inner shaft with the wire.The physician believed that he pinched both devices together because the inner shaft of the sds and the guide wire looked similar.No further complications were reported.The patient condition after the procedure was good.
|
| |
|
Manufacturer Narrative
|
|
Device is a combination device.(b)(6).Device evaluated by mfr: returned product consisted of two different eluvia self-expanding stent system stuck on a 0.035'' guidewire.The inner liner and tip of the device was checked for damage.The separated inner liner of the other eluvia device (complaint id: 11053762) was stuck inside the tip of this device.Visual examination revealed multiple buckling to the inner liner.The inner liner was separated 39.8cm from the tip.The proximal section of the device was missing.The missing pieces were the middle sheath, outer sheath, proximal inner, rack, thumbwheel, and the handle with its smaller miscellaneous components.Microscopic examination revealed no additional damages.The devices were placed in a water bath for several days and attempts to remove the wire was unsuccessful, so the devices were left attached together.The wire was sticking out approximately 9.4cm from the proximal end of the device and approximately 201.6cm from the distal tip of the second eluvia device.Inspection of the remainder of the device, revealed no other damage or irregularities.
|
| |
|
Event Description
|
|
It was reported that there was difficulty removing the device from the lesion, shaft became stuck on the guidewire, and the tip became separated from the stent delivery system.A 6x120, 130cm eluvia drug-eluting vascular stent system and a 6x80, 130cm of the same device were selected for a percutaneous transluminal angioplasty procedure in the patient's superficial femoral artery (sfa).The lesion was moderately tortuous, mildly calcified, and 90% stenosed.The physician used an ipsilateral approach.The first stent was successfully placed in the sfa.After deployment, the inner shaft and tip of the stent delivery system (sds) became detached without the physician realizing it.There had been difficulty removing the system, so when it was pulled, the tip was believed to have became separated.It was after the second eluvia was successfully deployed in the sfa that the detachment was noted.The second eluvia had been loaded on the guidewire without removing the detached distal tip of the first device.When catching was felt during post dilatation, the physician noted the detachment.The sds was stuck with the guidewire, and it was difficult to remove from the lesion.The physician planned to clamp the guidewire so that it would remain in the patient, and remove only the eluvia device with forceps, but the guidewire and eluvia were inadvertently pinched together so the proximal sds and the wire were pulled out of the body together leaving the inner shaft and tip.The blue outer shaft of the sds was removed from the yellow shaft during the use of the forceps.The tips of the two devices were removed from the sheath, stuck on the guidewire.The first shaft/tip was not stuck, but was not able to be removed due to the second device being stuck.Once removed from the body, it was noted that it was difficult to distinguish the device inner shaft with the wire.The physician believed that he pinched both devices together because the inner shaft of the sds and the guide wire looked similar.No further complications were reported.The patient condition after the procedure was good.It was further reported on 30 june 2019 that the first device was the 6x120, 130 cm eluvia stent, and the second used device was the 6x80, 130 cm eluvia stent.
|
| |
|
Search Alerts/Recalls
|
|
|
