BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Model Number 24653 |
Device Problems
Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
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Patient Problem
No Code Available (3191)
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Event Date 01/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event- age at time of event: 18 years or older.Initial reporter state: (b)(6).
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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