Catalog Number 1500250-12 |
Device Problem
Failure to Advance (2524)
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Patient Problems
Cardiac Arrest (1762); Tachycardia (2095); Prolapse (2475)
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Event Date 12/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Reportedly, the device is not returning for analysis.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.The additional xience sierra device referenced is filed under a separate medwatch report number.
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Event Description
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It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on multiple calcified lesions within the left anterior descending (lad) coronary artery.Pre-dilatation was performed.Following, both a 2.5x12mm (1500250-12, 9060441) and 2.25x8mm (1500225-08, 9050341) xience sierra stent delivery systems failed to cross the lesion mid-distal lad.Reportedly, the patient had calcified lesions throughout the lad.It was decided to abort the procedure.The patient was transferred to the critical care unit for monitoring.Shortly after arrival, the patient went into ventricular tachycardia, cardiac arrest, and was sent for emergency coronary artery bypass graft (cabg) placement.Reportedly, it was possible that some microvascular tissue or plaque disruption occurred due to the failure to crosses.The exact cause of the event was uncertain.No additional information was provided regarding this issue.
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Manufacturer Narrative
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The device was not returned for analysis.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 incidents from this lot.It should be noted that the reported patient effects of cardiac failure (cardiac arrest), cardiac arrhythmias (tachycardia) and prolapse are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified anatomy resulting in the reported failure to advance.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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