MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Model Number	INC-11597-132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Hemorrhage/Blood Loss/Bleeding (1888); Vasoconstriction (2126); Perforation of Vessels (2135); Dysphasia (2195); Pseudoaneurysm (2605); Hydrocephalus (3272); Restenosis (4576)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that thrombectomy procedure was performed using two vecta 74 catheters along with other devices to remove the thrombus/clots in patients experiencing ischemic stroke.Prior procedure, the patient neurological assessment showed tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 15 and mrs (modified rankin score) of 0.The first vecta 74 catheter device was used at the first pass and the aspiration of clot was performed successfully.Upon withdrawing the first vecta 74 catheter, it was noted to be stuck in the long sheath infinity device and for this reason the entire system including the vecta 74 catheter and the guide catheter were removed.The first vecta 74 catheter was noted to be stretched and uncoiled partially.After re-selecting the right internal carotid artery, the fresh second subject vecta 74 catheter along with other devices were used for the second pass.Due to small size of the target the subject vecta 74 catheter was unable to be placed past the occlusion and thus the aspiration was performed via the 3max catheter at the m2-3 division/bifurcation.Control angiography was performed which demonstrates improved , still showed the thrombolysis in cerebral infarction (tici ) of 2b.Afterwards, the third pass was performed with the same subject vecta 74 catheter (but no aspiration actually occurred).The 3 max was flushed and related with the 'wire introduced.The subject vecta 74 catheter was positioned within the m1.The 3 max device would not pass out the subject vecta 74 catheter.The wire wouldn't pass but the intermediate catheter would not follow.Throughout the entirety the procedure the patient was restless and moving significantly.At this point, it was decided to remove the system into a follow-up run as the patient was moving.At this point the patient jerks bilaterally and became unresponsive.Follow-up run showed extravasation of the middle cerebral artery inferior m2 segment.The 3 max and subject vecta 74 catheter were removed.Patient airway was secured to the balloon was prepped on the back table.Follow-up run through the guide catheter showed no active extravasation.At this time a dyna ct (computed tomography) was performed which showed subarachnoid hemorrhage but no large hematoma.At this 0.5 minutes had elapsed since the previous wada repeat run showed still no active extravasation.There is reocclusion of the m1 division and was not appropriate to traverse that area in light of the recent extravasation.The event was resolved and the patient was discharged on day 5-7 with mrs of 5.The patient¿s current condition are poor, tache and peg, opens eyes, and does not follow commands.The study facility reported that the vessel perforation was likely caused by the subject device vecta 74 catheter.The vessel perforation led to extravasation ,sah (subarachnoid hemorrhage) and a pseudoaneurysm that had to be treated with vessel sacrifice for pseudoaneurysm formamon.
Event or Problem Description
It was reported that thrombectomy procedure was performed using two vecta 74 catheters along with other devices to remove the thrombus/clots in patients experiencing ischemic stroke.Prior procedure, the patient neurological assessment showed tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 15 and mrs (modified rankin score) of 0.The first vecta 74 catheter device was used at the first pass and the aspiration of clot was performed successfully.Upon withdrawing the first vecta 74 catheter, it was noted to be stuck in the long sheath infinity device and for this reason the entire system including the vecta 74 catheter and the guide catheter were removed.The first vecta 74 catheter was noted to be stretched and uncoiled partially.After re-selecting the right internal carotid artery, the fresh second subject vecta 74 catheter along with other devices were used for the second pass.Due to small size of the target the subject vecta 74 catheter was unable to be placed past the occlusion and thus the aspiration was performed via the 3max catheter at the m2-3 division/bifurcation.Control angiography was performed which demonstrates improved , still showed the thrombolysis in cerebral infarction (tici ) of 2b.Afterwards, the third pass was performed with the same subject vecta 74 catheter (but no aspiration actually occurred).The 3 max was flushed and related with the 'wire introduced.The subject vecta 74 catheter was positioned within the m1.The 3 max device would not pass out the subject vecta 74 catheter.The wire wouldn't pass but the intermediate catheter would not follow.Throughout the entirety the procedure the patient was restless and moving significantly.At this point, it was decided to remove the system into a follow-up run as the patient was moving.At this point the patient jerks bilaterally and became unresponsive.Follow-up run showed extravasation of the middle cerebral artery inferior m2 segment.The 3 max and subject vecta 74 catheter were removed.Patient airway was secured to the balloon was prepped on the back table.Follow-up run through the guide catheter showed no active extravasation.At this time a dyna ct (computed tomography) was performed which showed subarachnoid hemorrhage but no large hematoma.At this 0.5 minutes had elapsed since the previous wada repeat run showed still no active extravasation.There is reocclusion of the m1 division and was not appropriate to traverse that area in light of the recent extravasation.The event was resolved and the patient was discharged on day 5-7 with mrs of 5.The patient¿s current condition are poor, tache and peg, opens eyes, and does not follow commands.The study facility reported that the vessel perforation was likely caused by the subject device vecta 74 catheter.The vessel perforation led to extravasation ,sah (subarachnoid hemorrhage) and a psuedoaneurysm that had to be treated with vessel sacrifice for pseudoaneurysm formamon.Update additional information: received additional information on 16-april-2021 stated that the vasospasm, sah (subarachnoid hemorrhage), right ica (internal carotid artery) aneurysm, and hydrocephalus occurred beyond 48 hours after the study procedure and the medical intervention was performed (more ivh for sah, coil sacrifice of the terminal to ophthalmic ica for ica aneurysm and ivd placed for hydrocephalus).The details of adverse events are listed below: ¿vasospasm: tcd evidence of asymptomatic vasospasm.Tcd suggestive mild vasospasm in left mca (middle cerebral artery) and left ica.¿sah stat cth demonstrating new sah bifrontal sulci and anterior basal cisterns; new loss of gray/white left posterior temporal lobe/occipital lobe c/w interval infarct; increased iph in right mca (middle cerebral artery) territory with new 3.7x2.1 cm hematoma, more ivh.¿right ica aneurysm: left supraclinoid ica with moderate spasm s/p balloon angioplasty right communicating segment ica aneurysm s/p coil sacrifice of the terminal to ophthalmic ica.¿hydrocephalus: hct showed worsening hydrocephalus, evd placed.Last hct concern for obstructive hydrocephalus.Continue csf draining with evd at 5mmhg.
Additional Manufacturer Narrative
B5 executive summary: updated f10 / h6 clinical signs code grid: added: vasoconstriction, aneurysm, and hydrocephalus health impact code grid: added: serious injury/impairment.
Additional Manufacturer Narrative
D4 expiration date: added.H4 manufacturing date: added.Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not returned; therefore, physical 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.It was reported that during procedure, vessel perforation and a pseudoaneurysm occurred which had to be treated with vessel sacrifice.Additional information received on 16-april-2021 stated that the vasospasm, sah (subarachnoid hemorrhage), right ica (internal carotid artery) aneurysm, and hydrocephalus occurred beyond 48 hours after the study procedure and medical intervention was performed (more ivh for sah, coil sacrifice of the terminal to ophthalmic ica for ica aneurysm, and ivd placed for hydrocephalus).Additional information provided by the customer indicated that the device was correctly removed from the dispenser hoop, the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the procedure, and the anatomy was minimally tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that thrombectomy procedure was performed using two vecta 74 catheters along with other devices to remove the thrombus/clots in patients experiencing ischemic stroke.Prior procedure, the patient neurological assessment showed tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 15 and mrs (modified rankin score) of 0.The first vecta 74 catheter device was used at the first pass and the aspiration of clot was performed successfully.Upon withdrawing the first vecta 74 catheter, it was noted to be stuck in the long sheath infinity device and for this reason the entire system including the vecta 74 catheter and the guide catheter were removed.The first vecta 74 catheter was noted to be stretched and uncoiled partially.After re-selecting the right internal carotid artery, the fresh second subject vecta 74 catheter along with other devices were used for the second pass.Due to small size of the target the subject vecta 74 catheter was unable to be placed past the occlusion and thus the aspiration was performed via the 3max catheter at the m2-3 division/bifurcation.Control angiography was performed which demonstrates improved , still showed the thrombolysis in cerebral infarction (tici ) of 2b.Afterwards, the third pass was performed with the same subject vecta 74 catheter (but no aspiration actually occurred).The 3 max was flushed and related with the 'wire introduced.The subject vecta 74 catheter was positioned within the m1.The 3 max device would not pass out the subject vecta 74 catheter.The wire wouldn't pass but the intermediate catheter would not follow.Throughout the entirety the procedure the patient was restless and moving significantly.At this point, it was decided to remove the system into a follow-up run as the patient was moving.At this point the patient jerks bilaterally and became unresponsive.Follow-up run showed extravasation of the middle cerebral artery inferior m2 segment.The 3 max and subject vecta 74 catheter were removed.Patient airway was secured to the balloon was prepped on the back table.Follow-up run through the guide catheter showed no active extravasation.At this time a dyna ct (computed tomography) was performed which showed subarachnoid hemorrhage but no large hematoma.At this 0.5 minutes had elapsed since the previous wada repeat run showed still no active extravasation.There is reocclusion of the m1 division and was not appropriate to traverse that area in light of the recent extravasation.The event was resolved and the patient was discharged on day 5-7 with mrs of 5.The patient¿s current condition are poor, tache and peg, opens eyes, and does not follow commands.The study facility reported that the vessel perforation was likely caused by the subject device vecta 74 catheter.The vessel perforation led to extravasation ,sah (subarachnoid hemorrhage) and a psuedoaneurysm that had to be treated with vessel sacrifice for pseudoaneurysm formamon.______________ update additional information: received additional information on 16-april-2021 stated that the vasospasm, sah (subarachnoid hemorrhage), right ica (internal carotid artery) aneurysm, and hydrocephalus occurred beyond 48 hours after the study procedure and the medical intervention was performed (more ivh for sah, coil sacrifice of the terminal to ophthalmic ica for ica aneurysm and ivd placed for hydrocephalus).The details of adverse events are listed below: ¿vasospasm: tcd evidence of asymptomatic vasospasm.Tcd suggestive mild vasospasm in left mca (middle cerebral artery) and left ica.¿sah stat cth demonstrating new sah bifrontal sulci and anterior basal cisterns; new loss of gray/white left posterior temporal lobe/occipital lobe c/w interval infarct; increased iph in right mca (middle cerebral artery) territory with new 3.7x2.1 cm hematoma, more ivh.¿right ica aneurysm: left supraclinoid ica with moderate spasm s/p balloon angioplasty right communicating segment ica aneurysm s/p coil sacrifice of the terminal to ophthalmic ica.¿hydrocephalus: hct showed worsening hydrocephalus, evd placed.Last hct concern for obstructive hydrocephalus.Continue csf draining with evd at 5mmhg.

• Brand Name: AXS VECTA 074 CATH 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 11478201
• Report Number: 3008853977-2021-00009
• Device Sequence Number: 3276352
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 14622-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 06/29/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/03/2021; 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 MAX MICROCATHETER.; ASPIRATION PUMP (STRYKER).; FATHOM GUIDEWIRE.; GUIDE CATHETER (UNKNOW MANUFACTURER).; GUIDEWIRE (TERUMO).; LS INFINITY SHEATH (STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 47 YR