Catalog Number 1804400-23 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
Injury
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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.The additional nc trek neo device referenced in b5 is filed under separate medwatch report number.D4: the udi is unknown due to the part/lot number was not provided.
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Event Description
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It was reported that procedure was to treat a 50% stenosed de novo lesion in the in the proximal left anterior descending (plad) artery with heavy calcification.The 4mm xience stent was implanted.The 4x8mm nc trek neo balloon dilatation catheter (bdc) was used for post dilatation; however, the balloon ruptured at 8 atmospheres (atm).Therefore, the bdc was removed from the patient and the stent was noted to be indented.A non-abbott balloon was used for further post-dilation of the stent indentation.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
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Event Description
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It was reported that procedure was to treat a 50% stenosed de novo lesion in the in the proximal left anterior descending (plad) artery with heavy calcification.The 4mm xience stent was implanted.The 4x8mm nc trek neo balloon dilatation catheter (bdc) was used for post dilatation; however, the balloon ruptured at 8 atmospheres (atm).Therefore, the bdc was removed from the patient and the stent was noted to be indented.A non-abbott balloon was used for further post-dilation of the stent indentation.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
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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 was unable to determine a conclusive cause for the reported difficult or delayed activation.The reported treatment appears to be related to operational context 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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