Model Number A34-34/C80-O20 |
Device Problems
Hole In Material (1293); Leak/Splash (1354); Stretched (1601)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
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Event Description
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The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.On (b)(6) 2017 a routine follow up computed tomography (ct) showed the patient had a dilation of the suprarenal cuff and an out-pouching of the main body stent at the distal part of the device.There is also a suspected type 3b endoleak of the suprarenal aortic extension.The physician is planning to reline the initial devices with a non-endologix stent.A secondary procedure has not been completed or scheduled for this patient.The patient has been reported to be doing well and is currently in stable condition.There have been no additional adverse events reported for this patient.
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Manufacturer Narrative
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At the completion of the complaint investigation, based on the information received, the clinical assessment was able to confirm a type 3b endoleak of the cuff and main body devices.Additionally a clinical evaluation was able to identify a dilation of the main body stent and refute the dilation of the suprarenal stent.The most likely cause of the type 3b endoleak of the cuff and main body was related to the use of strata material.There were no procedure related harms due to the lack of medical information surrounding both the implant and the event.To date the patient has not had a secondary procedure.The event devices remain implanted in the patient and were not available for further evaluation.The review of the manufacturing lot confirmed all devices met specifications prior to release.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.(b)(4).
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Search Alerts/Recalls
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