BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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Catalog Number 28-L2-15-160U |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2022 |
Event Type
malfunction
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Event Description
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After deployment of treo bifurcate device from delivery system, delivery system was retracted, and tip along with approximately 7 cm of hypotube remained on wire inside patient.Tip/hypotube was subsequently snared with "gooseneck" snare and removed.Treo 15 x 160 limb was deployed in the standard fashion, with rotation of the gray handle.After approximately 3 stents were deployed, the gray handle rotated without moving at all along the black "teeth" of the mechanical advantage (so gray handle was rotating "in place", and not moving longitudinally), and no further deployment of treo limb was possible.Physician subsequently pulled on gray handle while holding black treo grip, and device, with much resistance, was deployed.Patient outcome - "no injury to patient; no further evolution, nor treatment.".
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Manufacturer Narrative
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This complaint was involved with two devices.Device 1 is being reported under mdr-2247858-2022-00064.
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Manufacturer Narrative
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This complaint was involved with two devices.Device 1 is being reported under mdr-2247858-2022-00064 and device 2 is being reported under mdr-2247858-2022-00065.
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Event Description
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After deployment of treo bifurcate device from delivery system, delivery system was retracted, and tip along with approximately 7 cm of hypotube remained on wire inside patient.Tip/hypotube was subsequently snared with "gooseneck" snare and removed.Treo 15 x 160 limb was deployed in the standard fashion, with rotation of the gray handle.After approximately 3 stents were deployed, the gray handle rotated without moving at all along the black "teeth" of the mechanical advantage (so gray handle was rotating "in place", and not moving longitudinally), and no further deployment of treo limb was possible.Physician subsequently pulled on gray handle while holding black treo grip, and device, with much resistance, was deployed.Patient outcome - "no injury to patient; no further evolution, nor treatment.".
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