Model Number 1070275-18 |
Device Problems
Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Event Description
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It was reported that the procedure was to treat a de novo lesion located in the ostial circumflex arther that was both calcified and tortuous.An attempt was made to implant a xience xpedition des 2.75x18 rx stent delivery system failed to cross and the proximal shaft separated outside the patient.It is not known what replacement device was used to continue the procedure.However, there were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported deformation due to compressive stress was able to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the calcified and tortuous anatomy resulting in the reported failure to advance.Interaction and/or manipulation of the device resulted in the noted flared/stretched stent struts, the noted wrinkled inner/outer member and ultimately resulted in the reported deformation due to compressive stress/noted multiple hypotube bends.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: h6 - medical device problem code 1562 was removed and code 2889 was added.
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Event Description
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It was reported that the procedure was to treat a de novo lesion located in the ostial circumflex arther that was both calcified and tortuous.An attempt was made to implant a xience xpedition des 2.75x18 rx stent delivery system failed to cross and the proximal shaft separated outside the patient.It is not known what replacement device was used to continue the procedure.However, there were no reported adverse patient effects and no clinically significant delay in the procedure.Subsequently, after the initial report was filed the following information was received: the 2.75x18mm xience xpedition did not separate.The hypotube was kinked.No additional information was provided.
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Search Alerts/Recalls
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