MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM WITHOUT TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	M003SZAS30240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Intracranial Hemorrhage (1891)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 2 of the 3 reports the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.And the reported stroke and hemorrhage are known risks associated with endovascular procedures and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complications has been assigned to the reported patient stroke and hemorrhage.The device remains in patient.
Event or Problem Description
It was reported that the patient awoke from the stent-assisted coil embolization procedure intact and had stable vitals and neurological status until the neurological deterioration about 10 hours post-procedure and computed tomography revealed multiple intra-compartmental hemorrhages on right.So a right hemicraniectomy was given to the patient.However, there were no technical difficulties and no device malfunction was detected during the procedure.In the physician¿s opinion, the relationship between the event and stent (subject device) was unknown.Because subsequent angiography showed the stent-coiled aneurysm to be stable with stents and no unusual angiographic findings to suggest relationship to stent coiling other than the hemorrhage being in the territory supplied by the parent vessel which was treated.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM WITHOUT TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8156359
• Report Number: 3008881809-2018-00523
• Device Sequence Number: 268432
• Product Code: NJE
• UDI-Device Identifier: 07613252656166
• UDI-Public: 07613252656166
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 06/24/2023
• Device Catalogue Number: M003SZAS30240
• Device Lot Number: 20696936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• 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: 60 YR
• Patient Weight: 71