MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30150

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/03/2023

Event Type  Death  

Manufacturer Narrative

H3 other text : the device remains implanted inside the patient's vasculature.

Event Description

It was reported that during an endovascular procedure in a patient with subarachnoid hemorrhage (sah) of the basilar tip aneurysm which started bleeding periprocedural, physician made a y-stenting by placing two stents, subject stent was placed on the left p1 segment, and the second stent was placed on the right p1 segment.While coiling the aneurysm, thrombus formation was noticed at the left p1.Aspiration was performed with the aspiration catheter, but no changes were observed, so 10mg actilyse was given to the patient as medical management.There was a surgical delay of unknown duration.Patient was ct controlled for few days and was also on dual antiplatelet therapy(1000mg aspisol iv and brillique) post procedure.Few days later the patient died.Physician could not tell if the patient died due to the sah or thrombus formation.No additional information available.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.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 this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

Event Description

It was reported that during an endovascular procedure in a patient with subarachnoid hemorrhage (sah) of the basilar tip aneurysm which started bleeding periprocedural, physician made a y-stenting by placing two stents, subject stent was placed on the left p1 segment, and the second stent was placed on the right p1 segment.While coiling the aneurysm, thrombus formation was noticed at the left p1.Aspiration was performed with the aspiration catheter, but no changes were observed, so 10mg actilyse was given to the patient as medical management.There was a surgical delay of unknown duration.Patient was ct controlled for few days and was also on dual antiplatelet therapy(1000mg aspisol iv and brillique) post procedure.Few days later the patient died.Physician could not tell if the patient died due to the sah or thrombus formation.No additional information available.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM 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: 17244154
• MDR Text Key: 318262268
• Report Number: 3008881809-2023-00329
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); TARGET COIL (STRYKER); UNKNOWN ASPIRATION CATHETER
• Patient Outcome(s): Required Intervention; Other; Death
• Patient Sex: Female