Catalog Number 1011711-23 |
Device Problems
Collapse (1099); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/27/2015 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a 90% stenosed lesion in the proximal right coronary artery (rca).The 4.0x23mm xience prime stent delivery system (sds) was advanced to the target lesion and the stent implant was deployed without reported issue.However, during withdrawal of the sds, resistance was met with the 5-french guiding catheter.The sds was removed with force from the guiding catheter.After withdrawal, the sds balloon was noted to be wrinkled.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.The procedure was successfully completed.There was no additional information provided.
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Manufacturer Narrative
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(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint database revealed no other incidents reported for difficult to remove or balloon damage from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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It was reported that the procedure was to treat a lesion in an unspecified artery.The 4.0x23mm xience prime stent delivery system (sds) was advanced to the target lesion and the stent implant was deployed without reported issue.However, during withdrawal of the sds, resistance was met with the 5-french guiding catheter.After withdrawal, the sds balloon was noted to be damaged.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.The procedure was successfully completed.There was no additional information provided.
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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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