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

Catalog Number M003SZAS30240C

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

Patient Problems Stroke/CVA (1770); Dysphasia (2195)

Event Date 05/21/2017

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported during a clinical study that after implant of the stent (subject device) 1+ year post procedure the patient suffered aphasia, adjudicated as a minor ipsilateral ischemic stroke per the cec.It lasted less than 24 hours and resolved with residual effects.The treatment provided was medication.

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.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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.An assignable cause of anticipated procedural complication will be assigned to the reported event of patient stroke 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 during a clinical study that after implant of the stent (subject device) 1+ year post procedure the patient suffered aphasia, adjudicated as a minor ipsilateral ischemic stroke per the cec.It lasted less than 24 hours and resolved with residual effects.The treatment provided was medication.

• Brand Name: NEUROFORM ATLAS 3.0MM 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12479047
• MDR Text Key: 271658712
• Report Number: 3008881809-2021-00381
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: M003SZAS30240C
• Device Lot Number: 18551391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White