Model Number BA25-100/I16-40 |
Device Problems
Loss of or Failure to Bond (1068); Leak/Splash (1354); Stretched (1601)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/20/2018 |
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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Patient was initially implanted with an afx bifurcated and vela suprarenal device in 2014.Recently, patient present with an endoleak type 1a.On (b)(6) 2018, the patient was relined with an ovation graft.The endoleak was successfully sealed and patient is in stable condition.
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Manufacturer Narrative
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At the completion of the clinical evaluation and based on the information received, there was substantial evidence to refute the reported event of type ia endoleak.The clinical assessment determined that there was evidence to reasonably suggest the following: a non-endologix stent was implanted at index into the right iliac artery (off-label), there was multiple type ii endoleaks, and presence of stent cage dilation of the main body stent (28%) that were not included in the event as reported.These events were discovered during review of the event imaging study, 49 months post implant.Relatedness and procedure harms could not be determined.The patient was reported to be in stable condition.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).
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Event Description
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Additional information received refuting the reported type ia endoleak and rather, confirming multiple type ii endoleaks with stent cage dilcation of the main body.
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Search Alerts/Recalls
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