MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 30MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS45300

Device Problems Difficult to Insert (1316); Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during an endovascular procedure in a patient with subarachnoid hemorrhage sah with pcoma wide-neck aneurysm, resistance became bigger when delivered the subject stent to go into the microcatheter and the stent could not be advanced into microcatheter.Checked it and found the subject stent detached from delivery wire and stuck at proximal of microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Section b1 product problem - corrected - no product problem b5 - executive summary - updated section h1 type of reportable event - corrected - no malfunction f10 / h6 device code grid - updated h6 conclusion code grid - updated the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during an endovascular procedure in a patient with sub arachnoid hemorrhage sah with pcoma wide-neck aneurysm, resistance became bigger when delivered the subject stent to go into the microcatheter and the stent could not be advanced into microcatheter.Checked it and found the subject stent detached from delivery wire and stuck at proximal of microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.Update additional information received on 12-jul-2023 stated that the subject stent was detached in the microcatheter's hub (outside patient).No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.5MM X 30MM 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
• 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: 17243874
• MDR Text Key: 318565134
• Report Number: 3008881809-2023-00327
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45300
• Device Lot Number: 22510740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 6F GUIDE CATHETER (UNKNOWN).; SL10 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Race: Asian