Catalog Number 1550400-38 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The stent remains in the patient.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to deploy.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Event Description
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It was reported that the patient had a previously placed stent in a saphenous vein graft (svg) to the ostial posterior descending artery 10 years prior.This was another percutaneous coronary intervention to treat the same area.The lesion was a little eccentric with one focal stenosis at the ostium.During deployment of the xience sierra 4 x 38 mm stent at 10 atmospheres, the stent slipped back proximal toward the guide into the aorta.The ostial focal lesion was covered, however roughly 10mm of stent is now hanging outside the svg into the aorta.The stent balloon catheter was then re-advanced and inflated one more time to complete the procedure after taking a final angiogram.This was done to reinforce the stent to the vessel wall.The physician plans to keep patient on dual antiplatelet therapy for the remainder of his life.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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