The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system 5max reperfusion catheter and 5max separator.Prior to the procedure, intravenous tissue plasminogen activator (t-pa) was not administered.The 5max reperfusion catheter was advanced with another manufacturer's retrieval device and aspiration was performed with a 5max separator.The patient was given 3,000 units of heparin.During the procedure, dissection occurred in the cervical part of the ica and treatment was withheld.Embolization reoccurred and stenting was performed successfully.The patient recovered.Physician's comment: it was also likely that another manufacturer's retrieval device caused the dissection.The relation between the event and the penumbra system was not deniable.
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Conclusion: dissection is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00627.The hospital discarded the device.
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