Model Number 1550225-18 |
Device Problems
Leak/Splash (1354); Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/13/2020 |
Event Type
malfunction
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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 heavily calcified, mildly calcified de novo mid left circumflex artery that was 90% stenosed.A guide wire was able to be crossed to the lesion without issue.Pre-dilatation was performed with a 2 mm balloon.A 2.25 x 18 xience sierra was advanced and crossed the lesion despite slight resistance noted with the anatomy.Balloon inflation was attempted; however, it was noted under cine that the contrast flowed out around the distal end of the delivery system (sds).The sds was removed.The device was replaced with the same size of a non-abbott drug-eluting stent to continue to successfully complete the procedure.It was also noted that the stent implant looked flared at the proximal-distal edge.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported leak and material deformation were confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 determined the reported difficulty to advance and material deformation appear be related to circumstances of the procedure.A conclusive cause for the reported leak could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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Search Alerts/Recalls
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