Catalog Number 1550300-18 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/22/2019 |
Event Type
Injury
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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 stent remains in the patient.Investigation is not yet complete.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 during a coronary procedure to treat a chronic total occlusion in the mid circumflex (cx) artery, a 3.0 x 18 mm xience sierra stent was implanted.It was noted that the stent was underexpanded and additional post dilatation was performed using a 3.5 mm non-compliant balloon.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined that the reported difficulty to deploy and additional treatment appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Search Alerts/Recalls
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