Catalog Number 1500300-28 |
Device Problems
Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a mildly tortuous, moderately calcified left circumflex artery that was 65% stenosed.A 3x28mm xience sierra failed to cross after several attempts due to resistance with a non-abbott guide wire.It was noted that the inner member of the proximal shaft separated into two pieces.The delivery system was simply withdrawn and a new stent was used with the same size to finish the operation.There were no adverse patient effects and no clinically significant delay in the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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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a mildly tortuous, moderately calcified left circumflex artery that was 65% stenosed.A 3x28mm xience sierra failed to cross after several attempts due to resistance with a non-abbott guide wire.It was noted that the inner member of the proximal shaft separated into two pieces.The delivery system was simply withdrawn and a new stent was used with the same size to finish the operation.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, device analysis noted that there was no inner member nor proximal shaft separation noted on the returned device as reported.The account confirmed that by [separation] they meant that the inner parts of the shaft are [bent].There was no separation of two pieces.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported deformation due to compressive stress and difficult to advance were able to be confirmed.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 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 manipulation/inadvertent mishandling of the device resulted in the reported/noted deformation due to compressive stress (bends on the inner parts of the shaft) and ultimately resulting in the reported/noted difficult to advance due to resistance with other devices at the noted kinked area.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.H6, code 1562 removed.
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Search Alerts/Recalls
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