Model Number REL46J |
Device Problems
Burst Container or Vessel (1074); Compatibility Problem (2960)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A reliant stent graft balloon was used in conjunction with a non mdt stent graft system (afx) during the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported during the index procedure the reliant balloon ruptured when it came in contact with the stent graft.Per the physician the cause of the rupture was suspected to be related to the stent graft and commented that the stent graft used has an internal skeletal structure and there is a stent inside the graft.No additional clinical sequelae were reported and the patient is fine.
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Search Alerts/Recalls
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