Catalog Number 1125325-33 |
Device Problems
Collapse (1099); Deflation Problem (1149)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/18/2017 |
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 was received.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 the procedure was to treat a mildly tortuous, moderately calcified, de novo, 90% stenosed lesion in the mid left anterior descending artery.After the xience alpine 3.25 x 33 mm was implanted, the kissing balloon technique (kbt) was performed with the stent delivery balloon catheter and another balloon catheter.However, the xience alpine stent delivery balloon deflation took time.There was no deflation issue after stent deployment.Eventually, the balloon was completely deflated using a 30cc syringe.The shaft was found to be crushed.There were no adverse patient affects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The shaft damage was confirmed however the deflation issue was not confirmed.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issues however the shaft damage appears to be related to circumstances of the procedure.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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