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 Headache (1880); Hypersensitivity/Allergic reaction (1907)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) 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, allergic reaction and neurological/intracranial sequelae like headache are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.Subject device remains implanted.

Event Description

It was reported that following successful stent-assisted coil embolization with the subject stent, the patient complaints of severe headaches since the device was implanted.The patient is inquiring about nickel allergy since the patient is allergic to nickel.According to the physician, the allergy and headaches were not related to the subject stent device.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8232687
• MDR Text Key: 132563680
• Report Number: 3008881809-2019-00014
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613252656210
• UDI-Public: 07613252656210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Catalogue Number: M003SZAS45210
• Device Lot Number: 20423708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5 TARGET COILS (STRYKER)
• Patient Outcome(s): Other