Catalog Number 1125350-12 |
Device Problem
Physical Resistance (2578)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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Event Date 01/22/2018 |
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 relevant information.
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Event Description
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It was reported that the procedure was to treat a narrow and heavily calcified lesion located in the mid right coronary artery.An unspecified guide wire and a 3.5 x 12 mm xience alpine were advanced to the target lesion with resistance due to the anatomy and when the balloon was pressurized, the stent dislodged off the balloon.The following day, the stent was crushed in the target lesion and another unspecified stent was deployed to successfully complete the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned for analysis.The reported difficulty to deploy and physical resistance could not be replicated in a testing environment as it was based on circumstances 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 did not indicate a lot specific quality issue.Additionally, the investigation was unable to determine a conclusive cause for the reported difficulty to deploy as analysis identified that the balloon was not deployed as reported.The reported patient effects of device embedded appear to be due to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initially filed report, the following information was received:
when the balloon was pressurized the stent migrated down the vessel.
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Search Alerts/Recalls
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