MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30240

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that 16 months post procedure, thrombosis of the parent vessel was developed in the patient.The development of parent vessel thrombosis was caused due to the thrombosis of the stent (subject device) in the distal location of the artery.The event resolved without sequalae and without any neurological consequences.The patient¿s medical condition was good.There were no clinical consequences reported to the patient.

Event Description

It was reported that 16 months post procedure, thrombosis of the parent vessel was developed in the patient.The development of parent vessel thrombosis was caused due to the thrombosis of the stent (subject device) in the distal location of the artery.The event resolved without sequalae and without any neurological consequences.The patient¿s medical condition was good.There were no clinical consequences reported to the patient.

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and / or patient condition noted with the directions for use, product labeling and / or risk documentation files.H3 other text : device remains implanted in patient.

Event Description

It was reported that 16 months post procedure, thrombosis of the parent vessel was developed in the patient.The development of parent vessel thrombosis was caused due to the thrombosis of the stent (subject device) in the distal location of the artery.The event resolved without sequalae and without any neurological consequences.The patient¿s medical condition was good.There were no clinical consequences reported to the patient.

Manufacturer Narrative

The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.Device remains implanted in patient.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10645341
• MDR Text Key: 210361956
• Report Number: 3008881809-2020-00292
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2020

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: 10/31/2021
• Device Catalogue Number: M003EZAS30240
• Device Lot Number: 19418285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/09/2020; 12/11/2020
• Supplement Dates FDA Received: 11/12/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEADWAY DUO CATHETER (MICRO VENTION INC.).; VIA 27 CATHETER (SEQUENT MEDICAL).
• Patient Outcome(s): Other
• Patient Age: 60 YR