Catalog Number 1804275-18 |
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 02/27/2024 |
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 lesion located in the 1st diagonal in the left anterior descending (lad) coronary artery that was heavily calcified.Reportedly, the nc trek neo rx 3.00 x 12mm was advanced first in the distal lad.Then, the xience skypoint des 2.75 x 18 rx us stent delivery system was unable to advance out of the guide catheter.The physician lost guide engagement and wire position, and pulled both devices into the guide catheter.Once the guide catheter was re-engaged, and the physician had wire placement, the nc trek neo was re-advanced into the distal lad (but not inflated).The sds was unable to advance, with resistance.Then the sds was removed and noticed that the stent had separated from the shaft outside the patient.The nc trek neo appeared to be kinked on the shaft.Both devices were not able to be used and set aside.A new stent and balloon of the same size were opened and successfully used.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 material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.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 review of the complaint handling database identified no other similar incidents from this lot.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 interaction with the guiding catheter and/or other devices resulted in the reported difficult to advance.Manipulation of the device resulted in the noted device damages (torn guide wire exit notch, multiple hypotube bends/kinks) further contributing to the reported difficult to advance and ultimately resulted in the reported/noted material separation.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.
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Event Description
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Subsequent to the initial report being filed, the reported details were reviewed and it was been noted that the separation was reported to be at the shaft/hypotube.There was no stent separation.No additional information was provided.
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Search Alerts/Recalls
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