A physician attempted to remove an optease filter approximately 4 months after placement and it could not be removed with the cordis retrieval catheter and an ev3 gooseneck snare.During the attempt to remove the catheter and the snare, the snare could not be removed from the caudal hook requiring surgical intervention.The sales rep had advised the physician that per the ifu, retrieval was 23 days, but he decided to proceed.During the removal, the proximal portion of the filter would not collapse, so the filter had to be left in.When the dr.Attempted to retract the catheter and snare, the snare would not move.It appeared as if the snare had possibly "knotted" around the caudal hook.Due to being unable to separate the snare and the filter hook, the patient was sent to the hospital for surgery.The device will not be returned.
|
A physician attempted to remove an optease filter approximately four months after placement and it could not be removed with the cordis retrieval catheter and an ev3 gooseneck snare.During the attempt to remove the catheter and the snare, the snare could not be removed from the caudal hook requiring surgical intervention.The sales rep had advised the physician that per the ifu, retrieval was 23 days, but he decided to proceed.During the removal, the proximal portion of the filter would not collapse, so the filter had to be left in.When the dr.Attempted to retract the catheter and snare, the snare would not move.It appeared as if the snare had possibly ¿knotted¿ around the caudal hook.Due to being unable to separate the snare and the filter hook, the patient was sent to the hospital for surgery.The device will not be returned.The device was not returned for analysis nor was s sterile lot number provided in order to conduct a dhr.The reported ¿retrieval difficulty-unable to pull into retrieval catheter/gc¿ could not be confirmed as the retrieval catheter was not returned for analysis nor were procedural films provided.The exact cause of the difficulty experienced by the customer could not be conclusively determined; however, based on the information available for review, attempts to retrieve the filter following an extended dwell time (four months) likely contributed to the inability to retrieve the filter.The ifu notes that the optease filter can be safely retrieved up to 23 days in patients who no longer require protection against pulmonary embolism.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Additionally, there was difficulty reported during retrieval with a non-cordis snare (¿knotted¿).Without a sterile lot numbers or return of the device, there is no indication that these events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken at this time.
|