Catalog Number 1070350-23 |
Device Problems
Unstable (1667); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during a procedure of the heavily calcified, 95% stenosed, mid unspecified coronary artery, the 3.5 x 23 mm xience xpedition stent implant met anatomical resistance during advancement and became unstable [loose] on the balloon.The device was removed from the anatomy.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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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Internal file number: (b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported resistance met during advancement could not be replicated in a testing environment as it was based on operational circumstances.The reported loose stent was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the difficulties appear to be related to challenging anatomical conditions.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the previously filed medwatch reports, the following information was received: the vessel was a narrow/tight circumflex artery.No additional information was provided.
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Search Alerts/Recalls
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