MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS45240C

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

Patient Problems Infarction, Cerebral (1771); Ischemia Stroke (4418)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that approximately 21 month post-procedure with the subject stent, the patient experienced an ischemic stroke, identified on left pre-central gyrus and parietal lobes by magnetic resonance imaging (mri).According to the physician, the stroke was a serious adverse event and possibly related to the subject device and related to pre-existing condition/co-morbidity with a neurology assessment of etiology most likely atherosclerosis per discharge summary.The patient required hospitalization.The stroke was resolved with no residual effects 5 days post stroke event.

Manufacturer Narrative

Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.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.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.

Event Description

It was reported that approximately 21 month post-procedure with the subject stent, the patient experienced an ischemic stroke, identified on left pre-central gyrus and parietal lobes by magnetic resonance imaging (mri).According to the physician, the stroke was a serious adverse event and possibly related to the subject device and related to pre-existing condition/co-morbidity with a neurology assessment of etiology most likely atherosclerosis per discharge summary.The patient required hospitalization.The stroke was resolved with no residual effects 5 days post stroke event.

• Brand Name: NEUROFORM ATLAS 4.5MM X 24MM NO TIP- IDE
• 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: 10485889
• MDR Text Key: 205455993
• Report Number: 3008881809-2020-00253
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: M003SZAS45240C
• Device Lot Number: 18526896
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR