MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003EZAS30210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Thrombus (2101)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
During coil embolization treatment of unruptured a-com artery (anterior communication) aneurysm, the stent (subject device) was deployed and the non-stryker coil placed protruded from the stent and could not be repositioned.It was reported the coil separated, protruded into the a-com artery and a blood clot formed inside the stent and slowed blood flow, requiring medical intervention/thrombolysis.It was further reported intubation was removed 1 week post-procedure and the patient experienced lower extremity paralysis.The physician confirmed there was no allegation of malfunction against the stent and stated the coil protrusion and stent placement in a small vessel (1.8mm) caused the thrombosis.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned for analysis, therefore physical and functional tests could not be performed.However, patient thrombus and paralysis (patient complications) are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of known inherent risk of procedure was assigned to this event.
Event or Problem Description
During coil embolization treatment of unruptured a-com artery (anterior communication) aneurysm, the stent (subject device) was deployed and the non-stryker coil placed protruded from the stent and could not be repositioned.It was reported the coil separated, protruded into the a-com artery and a blood clot formed inside the stent and slowed blood flow, requiring medical intervention/thrombolysis.It was further reported intubation was removed 1 week post-procedure and the patient experienced lower extremity paralysis.The physician confirmed there was no allegation of malfunction against the stent and stated the coil protrusion and stent placement in a small vessel (1.8mm) caused the thrombosis.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7474776
• Report Number: 3008881809-2018-00196
• Device Sequence Number: 144977
• Product Code: NJE
• UDI-Device Identifier: 07613327313918
• UDI-Public: (01)07613327313918(17)230131(10)20226721
• Combination Product (Y/N): N
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 01/31/2023
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 20226721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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; Disability