Catalog Number FD40020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Ischemia Stroke (4418); Ruptured Aneurysm (4436)
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Event Date 10/25/2021 |
Event Type
Death
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Manufacturer Narrative
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Device is implanted in patient.
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Event Description
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It was reported that post a successful procedure of a large basilar tip aneurysm with the subject flow diverter, the patient had an aneurysm rupture.The patient had three much smaller aneurysms: right posterior inferior cerebellar, left proximal a1 and anterior communicating artery.The basilar aneurysm was treated first as it had the most risk.The patient had a sub arachnoid hemorrhage and sudden cardiac arrest which were reported as typical to basilar tip aneurysm rupture.The hemorrhage was diffuse as the patient was on dual antiplatelet therapy.There was no sign of rupture in any of the aneurysms in imaging performed thereafter.The physician is unable to confirm if the treated aneurysm or the other three aneurysms ruptured.The physician also is unable to confirm if the events were related to the subject flow diverter or any other stryker devices used.No other information is available.
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Event Description
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It was reported that post a successful procedure of a large basilar tip aneurysm with the subject flow diverter, the patient had an aneurysm rupture.The patient had three much smaller aneurysms: right posterior inferior cerebellar, left proximal a1 and anterior communicating artery.The basilar aneurysm was treated first as it had the most risk.The patient had a sub arachnoid hemorrhage and sudden cardiac arrest which were reported as typical to basilar tip aneurysm rupture.The hemorrhage was diffuse as the patient was on dual antiplatelet therapy.There was no sign of rupture in any of the aneurysms in imaging performed thereafter.The physician is unable to confirm if the treated aneurysm or the other three aneurysms ruptured.The physician also is unable to confirm if the events were related to the subject flow diverter or any other stryker devices used.No other information is available.
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Manufacturer Narrative
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H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that the treated aneurysm was a large ( 2 cm) basilar tip, and the patient had additional 3 smaller aneurysms which were untreated.The larger aneurysm was treated with surpass evolve and coils as well.Treatment was tolerated well.The patient then suffered a sub arachnoid hemorrhage (sah), sudden cardiac arrest, which is typical to basilar tip aneurysm rupture.Sah was diffuse, but the patient had dual antiplatelet therapy which may have caused the bleeding to be diffuse and not so localizable.There were no signs of rupture in any of the aneurysms in dsa performed thereafter.It is unknown for sure if it was the biggest and the treated aneurysm which ruptured but most probably it was.The treated aneurysm can rupture at any time before it is totally thrombosed.The patient passed away from aneurysm rupture.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment and an assignable cause of anticipated procedural complication will be assigned to the reported 'patient aneurysm rupture', 'patient death' and 'patient intracranial hemorrhage' as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the directions for use, product labelling and/or risk documentation files.
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Event Description
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It was reported that post a successful procedure of a large basilar tip aneurysm with the subject flow diverter, the patient had an aneurysm rupture.The patient had three much smaller aneurysms: right posterior inferior cerebellar, left proximal a1 and anterior communicating artery.The basilar aneurysm was treated first as it had the most risk.The patient had a sub arachnoid hemorrhage and sudden cardiac arrest which were reported as typical to basilar tip aneurysm rupture.The hemorrhage was diffuse as the patient was on dual antiplatelet therapy.There was no sign of rupture in any of the aneurysms in imaging performed thereafter.The physician is unable to confirm if the treated aneurysm or the other three aneurysms ruptured.The physician also is unable to confirm if the events were related to the subject flow diverter or any other stryker devices used.No other information is available.Update: received additional information on 05-sep-2023 stated that there was major ischemic ipsilateral stroke (based on cec (clinical events committee) adjudication revision).The adverse event has a possible relationship with the subject device and to disease under study.The adverse event is not related to dapt (dual anti-platelet therapy).Imaging revealed infarction in the treated vascular territory.The patient passed away on (b)(6)2021.No other information is available.
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Manufacturer Narrative
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Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that the treated aneurysm was a large ( 2 cm) basilar tip, and the patient had an additional along with 3 smaller aneurysm which were untreated.The larger aneurysm was treated with the subject stent and coils as well.Treatment was tolerated well.The patient then suffered a sub arachnoid hemorrhage (sah), sudden cardiac arrest, which is typical to basilar tip aneurysm rupture.Sah was diffuse, but the patient had dapt (dual anti-platelet therapy) which may cause the bleeding to be diffuse and not so localizable.There were no sign of rupture in any of the aneurysms in dsa (digital subtraction angiography) performed thereafter.It is unknown for sure if it was the biggest and the treated aneurysm which ruptured but the most probably it was.The treated aneurysm can rupture at any time before it is totally thrombosed.The patient passed away from aneurysm rupture.The device was used after the expiration date ( expiration date 23/07/2020 and the procedure date (b)(6) 2021).It is very unlikely that this would have contributed to the reported event.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported 'patient aneurysm rupture', 'patient death', 'patient stroke' and 'patient intracranial hemorrhage' as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the directions for use, product labelling and/or risk documentation files.The as analyzed 'device used past expiration date' will be assigned the assignable cause of 'user error' as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
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Search Alerts/Recalls
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