Catalog Number 1009527-28E |
Device Problems
Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other everlink device referenced is filed under a separate medwatch report number.The everlink device is an abbott vascular manufactured device which is distributed in (b)(4).Though this device is not commercially available for sale in the usa, it is similar to a device currently marketed for sale in the usa.
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Event Description
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It was reported that the procedure was to treat lesions located in the heavily tortuous mid to proximal left anterior descending coronary artery that were heavily calcified and 90% stenosed.An extension catheter (gc) was used to add support for the everlink stent delivery system (sds) to reach the lesion but the sds failed to cross into the lesion.During removal of the sds, the shaft broke in two pieces inside the gc.All was removed as a single unit.A second everlink sds was advanced, but also failed to cross the lesion and during removal, the shaft separated.It was thought that the two sds's may have separated in two due to the vessel characteristics and an interaction between the gc and the stent system.There was no reported adverse patient effect or a clinically significant delay in the procedure.Two new everlink stents were implanted to complete the procedure.No additional information was provided.
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Manufacturer Narrative
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A visual, functional and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.The reported difficult to remove could not be tested due to the condition of the returned device.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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