Catalog Number 1011708-28 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2024 |
Event Type
Injury
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Event Description
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It was reported that the procedure was to treat a moderately calcified, mildly tortuous left circumflex artery.During the deployment of the 2.75x28mm xience prime stent delivery system the balloon ruptured at 13 atmospheres.Resistance was felt with anatomy during removal and the tip, parts of the xience prime balloon separated inside the artery; however, the separated portions were removed with the help of another guide wire.There was no adverse patient sequela and no clinically significant delay reported.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 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 determined the reported complaints and unexpected medical intervention appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Na.
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Search Alerts/Recalls
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