MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035422030

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

Patient Problems Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

This is the 6th of 7 reports.Subject device is not available.

Event Description

It was reported that the physician was performing a stent assisted-coiling procedure of a small, un-ruptured, right internal carotid artery (ica) ophthalmic aneurysm in a relatively dysplastic vessel.The stent was successfully deployed across the aneurysm neck using jailed technique.The physician attempted to deploy a first coil 2mm x 3cm (subject device), but the coil appeared to be too big and long for the aneurysm, as the coil kept herniating downward into the parent vessel.Prior to detaching the coil, the physician removed the coil from the patient¿s body.The physician switched to a 1.5mm x 2cm coil.Unfortunately, the same issue happened with this coil as it continued to herniate down into the parent vessel.Prior to detaching the coil, the physician removed the coil from the patient¿s body.The physician switched to a 1mm x 1cm coil.This 1mm x 1cm coil successfully deployed into the aneurysm dome and was detached.Upon inspecting the coil mass, as the physician noticed that there was still open space in the middle of the aneurysm, the physician decided to deploy of a second 1mm x 1cm coil into the aneurysm dome.Unfortunately, this second 1mm x 1cm coil mechanically pushed the first detached coil downward and into the parent vessel through and past the stent, ultimately setting the first coil loose into the ica bloodstream.The first coil traveled downstream until it became stuck in the patient¿s distal middle cerebral artery (mca) branches.The physician removed the second 1mm x 1cm coil from the patient without detaching it.The physician then advanced a stent retriever through a microcatheter, successfully grabbed the loose coil, and started to pull the retriever proximally in hope of removing the stent retriever with the loose coil from the patient¿s body.Unfortunately, the retriever became stuck on the deployed stent as the physician attempted to pass by the struts of the stent.Attempt to re-sheath the retriever stent was not successful.The physician decided to pull the entire system (retriever, stent, and loose coil) as a single unit out of the patient¿s body.Post-procedure angiographic imaging did not reveal any vessel injury or issue to the patient and the final angiographic result looked similar to when the patient arrived ¿ with no coils or stents remaining implanted in the patient.Post- procedure, the patient appeared to be stable.Later the same day night (around 11:00 pm), the patient¿s blood pressure spiked to 186 mmhg.The physician didn¿t think the blood pressure was treated effectively, and the patient ended up having a massive sub- arachnoid hemorrhage.No additional information is available at this time.

Event Description

It was reported that that the physician was performing a stent assisted-coiling procedure of a small, un-ruptured, right internal carotid artery (ica) ophthalmic aneurysm in a relatively dysplastic vessel.The stent was successfully deployed across the aneurysm neck using jailed technique.The physician attempted to deploy a first coil 2mm x 3cm (subject device), but the coil appeared to be too big and long for the aneurysm, as the coil kept herniating downward into the parent vessel.Prior to detaching the coil, the physician removed the coil from the patient¿s body.The physician switched to a 1.5mm x 2cm coil.Unfortunately, the same issue happened with this coil as it continued to herniate down into the parent vessel.Prior to detaching the coil, the physician removed the coil from the patient¿s body.The physician switched to a 1mm x 1cm coil.This 1mm x 1cm coil successfully deployed into the aneurysm dome and was detached.Upon inspecting the coil mass, as the physician noticed that there was still open space in the middle of the aneurysm, the physician decided to deploy of a second 1mm x 1cm coil into the aneurysm dome.Unfortunately, this second 1mm x 1cm coil mechanically pushed the first detached coil downward and into the parent vessel through and past the stent, ultimately setting the first coil loose into the ica bloodstream.The first coil traveled downstream until it became stuck in the patient¿s distal middle cerebral artery (mca) branches.The physician removed the second 1mm x 1cm coil from the patient without detaching it.The physician then advanced a stent retriever through a microcatheter, successfully grabbed the loose coil, and started to pull the retriever proximally in hope of removing the stent retriever with the loose coil from the patient¿s body.Unfortunately, the retriever became stuck on the deployed stent as the physician attempted to pass by the struts of the stent.Attempt to re-sheath the retriever stent was not successful.The physician decided to pull the entire system (retriever, stent, and loose coil) as a single unit out of the patient¿s body.Post-procedure angiographic imaging did not reveal any vessel injury or issue to the patient and the final angiographic result looked similar to when the patient arrived ¿ with no coils or stents remaining implanted in the patient.Post- procedure, the patient appeared to be stable.Later the same day night (around 11:00 pm), the patient¿s blood pressure spiked to 186 mmhg.The physician didn¿t think the blood pressure was treated effectively, and the patient ended up having a massive sub- arachnoid hemorrhage.No additional information is available at this time.

Manufacturer Narrative

The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.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.Information available indicated that the device was confirmed to be in good condition prior to use.Additional information provided by the customer indicated that the subject coil was prepared as per the dfu and performed as intended, except that it did not stay within the aneurysm (due to apparently being too large for the space).Therefore, the coil was removed from the patient prior to detaching.An assignable cause of user preference issue will be assigned to the reported device cosmetic/appearance issue since this complaint is associated with a product that meets specifications; however, the user is dissatisfied with the function, performance, or appearance of the product.Based on available information, it cannot be definitively determined if the high blood pressure and massive sub-arachnoid hemorrhage were directly caused by the coil migration and subsequent intervention to remove the coil.The reported patient complications ( hypertension) and patient intracranial hemorrhage are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to these reported issues.

Event Description

It was reported that that the physician was performing a stent assisted-coiling procedure of a small, un-ruptured, right internal carotid artery (ica) ophthalmic aneurysm in a relatively dysplastic vessel.The stent was successfully deployed across the aneurysm neck using jailed technique.The physician attempted to deploy a first coil 2mm x 3cm (subject device), but the coil appeared to be too big and long for the aneurysm, as the coil kept herniating downward into the parent vessel.Prior to detaching the coil, the physician removed the coil from the patient¿s body.The physician switched to a 1.5mm x 2cm coil.Unfortunately, the same issue happened with this coil as it continued to herniate down into the parent vessel.Prior to detaching the coil, the physician removed the coil from the patient¿s body.The physician switched to a 1mm x 1cm coil.This 1mm x 1cm coil successfully deployed into the aneurysm dome and was detached.Upon inspecting the coil mass, as the physician noticed that there was still open space in the middle of the aneurysm, the physician decided to deploy of a second 1mm x 1cm coil into the aneurysm dome.Unfortunately, this second 1mm x 1cm coil mechanically pushed the first detached coil downward and into the parent vessel through and past the stent, ultimately setting the first coil loose into the ica bloodstream.The first coil traveled downstream until it became stuck in the patient¿s distal middle cerebral artery (mca) branches.The physician removed the second 1mm x 1cm coil from the patient without detaching it.The physician then advanced a stent retriever through a microcatheter, successfully grabbed the loose coil, and started to pull the retriever proximally in hope of removing the stent retriever with the loose coil from the patient¿s body.Unfortunately, the retriever became stuck on the deployed stent as the physician attempted to pass by the struts of the stent.Attempt to re-sheath the retriever stent was not successful.The physician decided to pull the entire system (retriever, stent, and loose coil) as a single unit out of the patient¿s body.Post-procedure angiographic imaging did not reveal any vessel injury or issue to the patient and the final angiographic result looked similar to when the patient arrived ¿ with no coils or stents remaining implanted in the patient.Post- procedure, the patient appeared to be stable.Later the same day night (around 11:00 pm), the patient¿s blood pressure spiked to 186 mmhg.The physician didn¿t think the blood pressure was treated effectively, and the patient ended up having a massive sub- arachnoid hemorrhage.No additional information is available at this time.

Manufacturer Narrative

H6: conclusion code: corrected h10: corrected: the device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.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.Information available indicated that the device was confirmed to be in good condition prior to use.Additional information provided by the customer indicated that the subject coil performed as intended, except that it did not stay within the aneurysm (due to apparently being too large for the space).Therefore, the coil was removed from the patient prior to detaching.Per the dfu: ¿to reduce the risk of coil migration, the diameter of the first and second coil should never be less than the width of the ostium¿.In the case of this complaint, it was stated that the ostium (aneurysm neck) was 3.42mm and this coil had a 1.5mm diameter (target 360 nano 1.5mm x 2cm).Based on this information, it is likely that use of an incorrectly sized coil as the first coil resulted in the reported issue.A probable cause of use error will be assigned to the as reported 'nv - user preference issue' since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.Based on available information, it cannot be definitively determined if the high blood pressure and massive sub-arachnoid hemorrhage were directly caused by the coil migration and subsequent intervention to remove the coil.The reported patient complications ( hypertension) and patient intracranial hemorrhage are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to these reported issues.

• Brand Name: TARGET 360 ULTRA 2MM X 3CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9434930
• MDR Text Key: 170507698
• Report Number: 3008881809-2019-00381
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540675835
• UDI-Public: 04546540675835
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

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
• Device Operator: Health Professional
• Device Model Number: M0035422030
• Device Catalogue Number: M0035422030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/07/2019
• Supplement Dates Manufacturer Received: 01/27/2020; 02/25/2020
• Supplement Dates FDA Received: 02/13/2020; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4)TARGET COILS (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TREVO 14 PRO MICROCATHETER (STRYKER); TREVO XP PROVUE RETRIEVER (STRYKER)
• Patient Outcome(s): Other