Catalog Number FD40020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
|
Event Date 06/13/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The subject device remains implanted.
|
|
Event Description
|
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica).The patient had severely tortuous anatomy.A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully.On the final angiography run, it was noticed that the distal vessel had a slow flow.A computed tomography (ct) scan was performed but the images were not clear.Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature.The physician applied a little glue to treat the ruptured vessel.No other information was provided.
|
|
Event Description
|
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica).The patient had severely tortuous anatomy.A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully.On the final angiography run, it was noticed that the distal vessel had a slow flow.A computed tomography (ct) scan was performed but the images were not clear.Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature.The physician applied a little glue to treat the ruptured vessel.No other information was provided.
|
|
Manufacturer Narrative
|
Product long description: unknown (surpass streamline).Catalog#: unknown.Lot/serial no.: unknown.The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.
|
|
Event Description
|
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica).The patient had severely tortuous anatomy.A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully.On the final angiography run, it was noticed that the distal vessel had a slow flow.A computed tomography (ct) scan was performed but the images were not clear.Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature.The physician applied a little glue to treat the ruptured vessel.No other information was provided.
|
|
Manufacturer Narrative
|
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the a product related root cause does not apply and the reported issue is due to a known physiological effect of the procedure and/or patient condition noted with the direction for use, product labelling and/or risk documentation files; therefore, an assignable cause of anticipated procedural complication was assigned to the as reported issues patient intracranial hemorrhage and patient vessel perforation.
|
|
Search Alerts/Recalls
|