The reported device has been discarded by the facility, so not product evaluation will be performed.With information available, there is no evidence of device malfunction.All products are 100% inspected for damage and irregularities during manufacture.The reported clinical experience cannot be conclusively determined.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that the patient had vasospasm during the flow diversion procedure.After verapamil was given to the patient.Vessel was remeasured and the pipeline embolization device (ped) had to be exchanged for a larger size.The reported ped was used to treat a patient's ruptured, previously coiled saccular aneurysm at the left posterior communication artery.The aneurysm measured 6 mm in max diameter and 4 mm in neck width.The landing zone artery was 2.53 mm distally and 4 mm proximally.Vessel tortuosity was described as normal.It was reported the ped was prepared as indicated in the instruction for use.Immediately before ped deployment, the patient had significant vasospasm.The physician reported the patient's vessel measurement had been 2.5 mm and 3.5 mm.A few minutes after verapamil was given, the patient's vessel was re-measured in the 4 mm range.Therefore, a large size ped had to be used to complete the procedure.No injury to the patient reported.The post procedural angiography revealed optimal flow diversion.
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