This is one of one initial/final mdr being submitted for this complaint with associated mfr# 3008264254-2016-00061 udi unavailable.Expiration date unknown, lot# of device is unknown.Terumo 0.35, coils stryker, sl 10 microcatheter, guide synchro, femoseal.Manufacturing date unknown, lot unknown.No catalogue/lot number has been provided therefore no dhr can be performed and the device remains unavailable for analysis.Allergic reactions are a known potential adverse reaction associated with all devices used during invasive procedures.The envoy ifu states: possible complications include, but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of the heart or vessel wall.Although there is not product specific information available, all products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that this patient was exposed to multiple potential allergy inducing agents, including the intra/post-operative medications, contrast media, all of the invasive devices, including the coils permanently implanted, and without the device available for further testing the root cause of the reported event cannot be confidently concluded.No further action is needed at this time.
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A female patient underwent coil embolization on (b)(6) 2016.A right sylvian saccular aneurysm was revealed on a scan following a traumatic brain injury.An unknown envoy 6f catheter was reported to be used during the procedure.Competitor's coils and microcatheter were used during the coiling procedure.There were no product related issues during the procedure and the patient was treated without complications.On (b)(6) 2016 patient was re-hospitalized for a persistent brain deficit post-embolization and numbing of the left arm.This event was reported initially as allergic/immune reaction.Presence of right hemispheric nodular lesions was noted with discreet hemorrhagic reshuffle.Patient was given heparin for 24 hours, aggrastat 12 hours, and was take aspirin for 3 months.It was reported that the patient still has light numbing.It was also reported that the event was related to envoy catheter.
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