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

Catalog Number M003EZAS30210

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

Patient Problems Infarction, Cerebral (1771); Hemorrhage, Cerebral (1889); Perforation of Vessels (2135)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient¿s anatomy.

Event Description

It was reported that during the procedure, the posterior cerebral artery (pca) was ruptured when placing the subject stent to perform a y-stenting technique on the basilar top aneurysm (ba) which caused a stroke.The physician was able to embolize posterior cerebral artery (p1) via posterior communicating artery (p-com) and stopped bleeding and the procedure was completed.The patient is now currently in stable condition.No additional information was provided.

Manufacturer Narrative

The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the reported events are known and anticipated complications to these types of procedures, patient condition and are listed as such in the device directions for use (dfu); therefore, an assignable cause of anticipated procedural complication was assigned to the as reported issues patient vessel perforation, patient aneurysm ruptured, patient stroke and patient hemorrhage, blood loss with sequelae.

Event Description

It was reported that during the procedure, the parent vessel of the posterior cerebral artery (pca) was ruptured when the subject stent used to perform a y-stenting technique on the basilar artery (ba) top aneurysm which caused a stroke.The physician was able to embolize posterior cerebral artery (p1) via posterior communicating artery (p-com) and stopped the bleeding.The procedure was completed successfully.The patient is now currently in stable condition.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 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: 8714635
• MDR Text Key: 148519739
• Report Number: 3008881809-2019-00175
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H020002/S04
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 21008431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention