MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that during the anterior cerebral aneurysm (aca) coil embolization procedure while placing the subject coil inside the aneurysm the physician noticed a thrombus forming close to the neck of the aneurysm.The physician stopped the coiling and removed the microcatheter from the patient's anatomy.Administered pharmacological agents to the patient to address the thrombus, after a few minutes, the physician did a contrast run and still saw slow flow into the aca and contralateral a2.The physician planned to stent the artery so another microcatheter and guide wire was placed into the ipsilateral a2.At this point, there was no contrast seen flowing into the other a2, then the physician decided to perform aspiration.Guidewire and microcatheter were placed into the vessel had the thrombus/no blood flow.The physician took the guide wire distal to the location of the thrombus and used the aspiration catheter to take the thrombus out of the patient's anatomy.Prior to the aspiration the physician performed a contrast run through the artery, extravasation and artery perforation could be seen near the contralateral a2.The physician administers protamine to the patient as a additional medication and used an occlusion balloon catheter to place up to the site of artery perforation.Then the occlusion balloon was inflated in the a1 segment without any difficulty.The occlusion balloon was deflated and navigated proximally into the internal carotid artery (ica).The occlusion balloon was again inflated and visible upon inflation and the contrast run showed that there had been a rupture of the internal carotid artery.The occlusion balloon and guidewire were removed from the patient's anatomy.As a medical intervention, the physician placed an external ventricular drain (evd) and coiled off the ica.Post procedure the patient passed away and the physician does not allege any malfunction against the device used in the procedure that could have caused the patient death.No further information available related to the reported event.

Manufacturer Narrative

This is 2 of 4 reports.The device is not available to the manufacturer.

Event Description

It was reported that during the anterior cerebral aneurysm (aca) coil embolization procedure while placing the subject coil inside the aneurysm the physician noticed a thrombus forming close to the neck of the aneurysm.The physician stopped the coiling and removed the microcatheter from the patient's anatomy.Administered pharmacological agents to the patient to address the thrombus, after a few minutes, the physician did a contrast run and still saw slow flow into the aca and contralateral a2.The physician planned to stent the artery so another microcatheter and guide wire was placed into the ipsilateral a2.At this point, there was no contrast seen flowing into the other a2, then the physician decided to perform aspiration.Guidewire and microcatheter were placed into the vessel had the thrombus/no blood flow.The physician took the guide wire distal to the location of the thrombus and used the aspiration catheter to take the thrombus out of the patient's anatomy.Prior to the aspiration the physician performed a contrast run through the artery, extravasation and artery perforation could be seen near the contralateral a2.The physician administers protamine to the patient as a additional medication and used an occlusion balloon catheter to place up to the site of artery perforation.Then the occlusion balloon was inflated in the a1 segment without any difficulty.The occlusion balloon was deflated and navigated proximally into the internal carotid artery (ica).The occlusion balloon was again inflated and visible upon inflation and the contrast run showed that there had been a rupture of the internal carotid artery.The occlusion balloon and guidewire were removed from the patient's anatomy.As a medical intervention, the physician placed an external ventricular drain (evd) and coiled off the ica.Post procedure the patient was passed away and the physician does not allege any malfunction against the device used in the procedure that could have caused the patient death.No further information available related to the reported event.

Manufacturer Narrative

Although the device history record (dhr) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.No visual or functional inspection was performed due to subject coil 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 during the case, there was a thrombus formed close to the neck of the aneurysm and an artery perforation, subsequently, the patient suffered a rupture of the internal carotid artery causing extravasation.Post procedure the patient passed away.Therefore, s5 will be assigned to the actual severity of harm for this complaint.It was also reported that there was no alleged deficiency by the physician with any of the products used in this case.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

Manufacturer Narrative

Although the device history record (dhr) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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 during the case, there was a thrombus formed close to the neck of the aneurysm and an artery perforation, subsequently, the patient suffered a rupture of the internal carotid artery causing extravasation.Post procedure the patient passed away.It was also reported that there was no alleged deficiency by the physician with any of the products used in this case.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint of 'patient thromboembolic event' and 'patient embolus'.

Event Description

It was reported that during the anterior cerebral aneurysm (aca) coil embolization procedure while placing the subject coil inside the aneurysm the physician noticed a thrombus forming close to the neck of the aneurysm.The physician stopped the coiling and removed the microcatheter from the patient's anatomy.Administered pharmacological agents to the patient to address the thrombus, after a few minutes, the physician did a contrast run and still saw slow flow into the aca and contralateral a2.The physician planned to stent the artery so another microcatheter and guide wire was placed into the ipsilateral a2.At this point, there was no contrast seen flowing into the other a2, then the physician decided to perform aspiration.Guidewire and microcatheter were placed into the vessel had the thrombus/no blood flow.The physician took the guide wire distal to the location of the thrombus and used the aspiration catheter to take the thrombus out of the patient's anatomy.Prior to the aspiration the physician performed a contrast run through the artery, extravasation and artery perforation could be seen near the contralateral a2.The physician administers protamine to the patient as a additional medication and used an occlusion balloon catheter to place up to the site of artery perforation.Then the occlusion balloon was inflated in the a1 segment without any difficulty.The occlusion balloon was deflated and navigated proximally into the internal carotid artery (ica).The occlusion balloon was again inflated and visible upon inflation and the contrast run showed that there had been a rupture of the internal carotid artery.The occlusion balloon and guidewire were removed from the patient's anatomy.As a medical intervention, the physician placed an external ventricular drain (evd) and coiled off the ica.Post procedure the patient was passed away and the physician does not allege any malfunction against the device used in the procedure that could have caused the patient death.No further information available related to the reported event.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14584885
• MDR Text Key: 293259415
• Report Number: 3008881809-2022-00264
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 3MAX REPERFUSION CATHETER (PENUMBRA); EXCELSIOR SL-10 MICROCATHETER (STRYKER); PC400 COIL (PENUMBRA); SYNCHRO SELECT STANDARD GUIDEWIRE (STRYKER); TRANSFORM OCCLUSION BALLOON CATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention