MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS45210

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Thrombus (2101)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that the patient presented with onset of left middle cerebral artery (mca) syndrome that was identified as a dissected occlusion of the left cervical carotid.The patient underwent successful angioplasty and stenting with 3 stents including the subject device.The three overlapping stents achieved excellent endoluminal reconstruction of the vessel with recananalization of the carotid.Six day-post-procedure, the patient presented with right hemiplegia and evidence on computed tomography (ct) angiography of occlusion through the stented segment.Angiography demonstrated thrombosis of the cervical internal carotid artery throughout the stented segment, without apparent intracranial reconstitution.Aspiration was performed, with persistent occlusion.After multiple attempts to navigate a catheter through the stented segment, it was apparent the subject stent bridging the two largest stents of the cervical carotid artery was compromised.A (non-stryker) balloon and (non-stryker) stent were utilized to reopen the artery; additional angiography demonstrated an obvious intracranial dissection of the left petrous internal carotid artery as well, with persistent thrombosis of one large m2 branch of the mca.Because of the length of the procedure and the complexity, it was elected at this point to conclude any further intervention.According to the physician, the reason for in-stent thrombosis was the underlying dissection and the subsequent entire stent construct thrombosed.According to the physician, the reason for intracranial dissection of the left petrous internal carotid artery observed six-day-post-procedure was the difficulty to access distally to subject stent with a non stryker micro-wire dissection.

Event Description

It was reported that the patient presented with onset of left middle cerebral artery (mca) syndrome that was identified as a dissected occlusion of the left cervical carotid.The patient underwent successful angioplasty and stenting with 3 stents including the subject device.The three overlapping stents achieved excellent endoluminal reconstruction of the vessel with recentralization of the carotid.Six day-post-procedure, the patient presented with right hemiplegia and evidence on computed tomography (ct) angiography of occlusion through the stented segment.Angiography demonstrated thrombosis of the cervical internal carotid artery throughout the stented segment, without apparent intracranial reconstitution.Aspiration was performed, with persistent occlusion.After multiple attempts to navigate a catheter through the stented segment, it was apparent the subject stent bridging the two largest stents of the cervical carotid artery was compromised.A (non-stryker) balloon and (non-stryker) stent were utilized to reopen the artery; additional angiography demonstrated an obvious intracranial dissection of the left petrous internal carotid artery as well, with persistent thrombosis of one large m2 branch of the mca.Because of the length of the procedure and the complexity, it was elected at this point to conclude any further intervention.According to the physician, the reason for in-stent thrombosis was the underlying dissection and the subsequent entire stent construct thrombosed.According to the physician, the reason for intracranial dissection of the left petrous internal carotid artery observed six-day-post-procedure was the difficulty to access distally to subject stent with a non stryker micro-wire dissection.

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 event could not be confirmed; however, the reported patient in-stent-thrombosis and neurological deficits are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9205786
• MDR Text Key: 162852282
• Report Number: 3008881809-2019-00314
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Catalogue Number: M003SZAS45210
• Device Lot Number: 20471432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XACT STENT (ABBOTT); ZILVER STENT (COOK MEDICAL)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 88