MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003N3EZ25150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis (2100); Vasoconstriction (2126)
Date of Event	04/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.
Event or Problem Description
It was reported that following angioplasty, a stent (subject device) was placed in the left middle cerebral artery (mca) from the distal m1 to the proximal m2 branch to pin the plaque against the walls of the artery.Follow up angiography showed wide patency of the stent and that the plaque was securely fastened against the walls of the artery.Verapamil was administered intra-arterially to treat mild vasospasm in the left internal carotid artery (ica).An additional follow up angiography showed improvement of the vasospasm, wide patency of the stent with no evidence of in-stent thrombosis and no evidence of thromboembolic complications.The patient was discharged the following day; however, approximately five (5) days later the patient returned having mild word finding difficulties.Imaging showed a partial occlusion of the stent from the mid to the distal portion of the device, resulting in partial occlusion of the m2 branch; however, with supportive filling from collateral circulation.Mechanical clot aspiration and balloon angioplasty was performed to treat the complication, which resulted in some improvement of flow but a prominent occlusion at the m2 level remained.A thrombolytic was slowly administered intra-arterially into the left mca, followed by another round of balloon angioplasty at the site of the thrombus and an additional dose of thrombolytic.Final angiography showed significant improvement in blood flow and the patient was put on a heparin drip.The next day a follow up angiography showed the stent was widely patent and the patient did not experience any further neurologic symptoms.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, vasospasm, thrombosis and stroke are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Event or Problem Description
It was reported that following angioplasty, a stent (subject device) was placed in the left middle cerebral artery (mca) from the distal m1 to the proximal m2 branch to pin the plaque against the walls of the artery.Follow up angiography showed wide patency of the stent and that the plaque was securely fastened against the walls of the artery.Verapamil was administered intra-arterially to treat mild vasospasm in the left internal carotid artery (ica).An additional follow up angiography showed improvement of the vasospasm, wide patency of the stent with no evidence of in-stent thrombosis and no evidence of thromboembolic complications.The patient was discharged the following day; however, approximately five (5) days later the patient returned having mild word finding difficulties.Imaging showed a partial occlusion of the stent from the mid to the distal portion of the device, resulting in partial occlusion of the m2 branch; however, with supportive filling from collateral circulation.Mechanical clot aspiration and balloon angioplasty was performed to treat the complication, which resulted in some improvement of flow but a prominent occlusion at the m2 level remained.A thrombolytic was slowly administered intra-arterially into the left mca, followed by another round of balloon angioplasty at the site of the thrombus and an additional dose of thrombolytic.Final angiography showed significant improvement in blood flow and the patient was put on a heparin drip.The next day a follow up angiography showed the stent was widely patent and the patient did not experience any further neurologic symptoms.

• Brand Name: NEUROFORM 3 EZ 2.5 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5660056
• Report Number: 3008853977-2016-00186
• Device Sequence Number: 350746
• Product Code: NJE
• UDI-Device Identifier: 04546540697738
• UDI-Public: (01)04546540697738(17)181031(10)18690106
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: H020002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2016

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: 10/31/2018
• Device Catalogue Number: M003N3EZ25150
• Device Lot Number: 18690106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR