BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Model Number 24653 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 03/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that the tip of the device broke off and a snare was used to remove it from the patient.A 7x120x130 eluvia drug-eluting vascular stent system was selected for a superficial femoral artery (sfa) angioplasty procedure.A non bsc 7f guide sheath was used.The aortic arch was steep, but not broad.During insertion, resistance was felt, but not too excessive.The stent deployed ok, but resistance was felt upon removal.The tip of the delivery system broke off and the outer shaft was stripped.The physician made a popliteal puncture and snared the tip which was stuck on the wire.The entire system was removed with difficulty and a significant amount of time.There were no patient complications reported.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr: the stent was implanted and did not return for product analysis.Returned product consisted of an eluvia self-expanding stent system stuck inside what appeared to be the reported cook 7f anl guide sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the inner liner was separated 16mm from the tip and appeared to have been stretched prior to separating.The rack was separated 13.7cm from the knob.There was approximately 7mm of the rack sticking out of the handle.There was a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.There was blood present on and in the device.The guide wire used in the clinical procedure was not returned with the device so a.035 test guide wire was used for functional testing, which revealed the wire advanced through the inner liner and was able to pass through the device.Due to severe damages on the non-bsc guide sheath, it could not be removed from the stent system.There were multiple buckles to the outer sheath, scratch marks along the sheath, part of the coil was pulled out of the distal end, and the ptfe liner was pulled out the distal end in strips.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the inner liner was separated.Analysis also found that the inner liner appeared to have been stretched, which suggests it could have contributed to the reported difficulty to remove and froze on wire.The reported shaft stripped, and concertina (buckling) was noticed on the competitor's device and not on the bsc device.
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Event Description
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It was reported that the tip of the device broke off and a snare was used to remove it from the patient.A 7x120x130 eluvia drug-eluting vascular stent system was selected for a superficial femoral artery (sfa) angioplasty procedure.A non bsc 7f guide sheath was used.The aortic arch was steep, but not broad.During insertion, resistance was felt, but not too excessive.The stent deployed ok, but resistance was felt upon removal.The tip of the delivery system broke off and the outer shaft was stripped.The physician made a popliteal puncture and snared the tip which was stuck on the wire.The entire system was removed with difficulty and a significant amount of time.There were no patient complications reported.
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