Catalog Number 1011708-33 |
Device Problems
Material Separation (1562); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was performed to treat a de novo lesion in the left circumflex (cx) coronary artery with heavy calcification, heavy tortuosity and 90% stenosis.After pre dilating the lesion with an unspecified balloon, the 2.75x33mm xience prime stent delivery system (sds) was being advanced and met resistance due to the anatomy when it was noticed that the shaft was separated in two pieces.The separate portion was simply withdrawn.Another unspecified stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No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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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 separation (shaft) was confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 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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