Catalog Number 1070225-15 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat the diagonal coronary artery with 90% stenosis.The 2.25x15 mm xience xpedition stent delivery system (sds) was advanced with resistance noted with another unspecified device which was present at the lesion.The stent mesh/struts were noted to be damaged after advancing through the lesion and the sds was then removed.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the shaft of the device was bunched and torn 4mm proximal to the guidewire exit notch for a length of 2mm.Follow-up with the site confirmed they were aware of the damage no additional information was provided.
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Manufacturer Narrative
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Facility name: (b)(6).Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Manufacturer Narrative
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The device was returned for analysis.The reported material deformation, bent shaft, and torn shaft were confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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