MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS40240C

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

Patient Problems Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported during a clinical study that two (2) years post procedure, a follow up angiogram showed the aneurysm was still filling after treatment involving the stent (subject device) in stent assisted coiling of left internal carotid artery (ica) aneurysm located at left ica bifurcation/terminus.Physician planned to perform surgery/endovascular intervention as treatment.Outcome was reported as resolved with no residual effects.No further information is available.

Event Description

It was reported during a clinical study that two (2) years post procedure, a follow up angiogram showed the aneurysm was still filling after treatment involving the stent (subject device) in stent assisted coiling of left internal carotid artery (ica) aneurysm located at left ica bifurcation/terminus.Physician planned to perform surgery/endovascular intervention as treatment.Outcome was reported as resolved with no residual effects.No further information is available.

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 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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.Therefore, a probable cause of anticipated procedural complication was assigned to this event.H3 other text : device remains implanted in patient.

• Brand Name: NEUROFORM ATLAS 4.0MM 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
• MDR Report Key: 11694734
• MDR Text Key: 246309011
• Report Number: 3008881809-2021-00165
• 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
• Report Date: 07/13/2021

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: 01/31/2021
• Device Catalogue Number: M003SZAS40240C
• Device Lot Number: 18798597
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TARGET COIL (STRYKER); TARGET COIL (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR