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Model Number 85451 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aneurysm (1708); Calcium Deposits/Calcification (1758)
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Event Date 07/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Follow-up report will be submitted upon completion of the investigation.
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Event Description
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Reported event stated that on (b)(6) 2020 a 2-year ct was performed.The site noted that the ct scan revealed the devices were patent with no evidence of separation of components, kink, barb separation, stent fracture, or device compression.A type ii endoleak (noted since the post procedure ct on (b)(6) 2018) and an unknown endoleak were noted.The core lab showed a clear type ii endoleak on delayed phase ct.However, on arterial phase, early contrast near the l renal fen - appears consistent with either a type 1c or 3 endoleak at left renal.On (b)(6) 2020, the patient was diagnosed with a type ic endoleak to left renal artery stent.A secondary intervention was completed on the same day.A coil embolization and left renal stent placement icast stent (7x22x120) were performed.The site indicated the secondary intervention was successful.
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Event Description
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N/a.
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Manufacturer Narrative
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Additional information section: h.6.
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Event Description
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N/a.
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Manufacturer Narrative
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This complaint is associated with the zenith® p branch® pivotal study, which is a clinical trial approved by fda to study the safety and effectiveness of the zenith® p branch® endovascular graft in combination with the atrium icast¿ covered stents in the treatment of abdominal aortic aneurysms.Clinicaltrials.Gov identifier: (b)(4).Based on the details provided and the images from the case it is difficult to determine the cause of the endoleak described as a 1c endoleak.Endoleaks can occur if the stent is not sealed well against the inside wall of the renal artery creating a channel at the end of the stent.In this case it is likely that the leak as described is due to the possibility that the stent in the renal artery was not well opposed to the vessel wall.Based on the review of the details, the device history records review and images provided the complaint can be confirmed however the cause of the endo leak cannot be determined to be directly related to the stent.In this regard the complaint root cause is likely attributed to the operational context.A review of applicable device history records was conducted.There were no related non conformances noted during this build of devices or indications of any manufacturing defect that could have contributed to the issue.After review of the details of the complaint provided, as well as review of the published clinical literature as cited in the complaint¿s medical assessment that highlights the possible risks and complications known to occur following placement of icast¿ balloon expandable covered stent in the renal artery through a fenestration of the zenith® p-branch® graft, one can infer the unfortunate injuries suffered by this patient are potentially multifactorial and getinge¿s icast¿ balloon expandable covered stent was not the only attributing factor.The factors likely include but are not limited to, aneurysmal sac increase, mismatch between length of left renal artery and stent device, renal artery tortuosity and surgical technique such as excessive manipulation and use of force during device placement.Based on the details of the complaint and investigation conducted, it is likely that the complaint is an artifact of the operational context.H3 other text : device not available for return.
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Search Alerts/Recalls
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