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

Catalog Number M003EZAS45300

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

Patient Problem Thromboembolism (2654)

Event Date 12/05/2019

Event Type  Injury  

Event Description

It was reported that thrombosis was found in the ic top portion, post ic-pc (internal carotid- posterior communicating artery) aneurysm stent-assisted coil embolization procedure.Thrombolysis was performed with urokinase.The procedure was completed successfully and currently patient medical status is reported to as good.There are no further clinical consequences reported to the patient.

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 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 stent was not returned but the guidewire was returned and noted to be damaged due to the difficulties in removing from the stent.An assignable cause of caused by other will be assigned to the reported event as the investigation indicates another product caused the event.An assignable cause of anticipated procedural complication will be assigned to the reported patient thromboembolic event and patient surgical or medical intervention required, 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 thrombosis was found in the ic top portion, post ic-pc (internal carotid- posterior communicating artery) aneurysm stent-assisted coil embolization procedure.Thrombolysis was performed with urokinase.The procedure was completed successfully and currently patient medical status is reported to as good.There are no further clinical consequences reported to the patient.

• 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 ; IE NA
• MDR Report Key: 9911627
• MDR Text Key: 186203295
• Report Number: 3008881809-2020-00082
• 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: 05/20/2020

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: 02/06/2024
• Device Catalogue Number: M003EZAS45300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL10 MICROCATHETER (STRYKER); TRANSEND EX 14 PLATINUM 205CM (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
• Patient Outcome(s): Other; Required Intervention