The lot number was not provided; therefore, a lot history review was not performed.
The sample was not returned.
Medical records were not provided.
Therefore, the investigation is inconclusive for the alleged perforation of the inferior vena cava (ivc), filter tilt, filter migration and retrieval difficulties.
A definite root cause for the reported event could not be determined.
The device was labeled for single use.
(b)(4).
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This report summarizes one malfunction.
A review of the reported information indicated that model unknown vena cava filter allegedly experienced tilt, perforation, migration and difficult to remove.
This information was received from one source.
This malfunction involved one patient with no consequences.
Age, weight, and gender were not provided for the patient.
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