Catalog Number 1011710-28 |
Device Problems
Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported the procedure was to treat a moderately calcified de novo lesion in the proximal left anterior descending (lad) artery.The 3.5x28mm xience prime stent delivery system (sds) was advanced however it failed to cross the lesion due to the anatomy.During the attempt to cross, the shaft kinked and then separated outside of the patient anatomy.The device was removed and the procedure abandoned.The patient was referred to surgery.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).A visual and dimensional inspection was performed on the returned device.The reported shaft detachment and kinked shaft were confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed and analysis of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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