MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS45210

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

Patient Problems Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

This 2 of 2 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during coil embolization using the stent (subject device), intraoperative rupture occurred and the patient experienced an intracranial hemorrhage.The patient's outcome was unknown.No other information is available.

Event Description

It was reported that during coil embolization using the stent (subject device), intraoperative rupture occurred and the patient experienced an intracranial hemorrhage.The patient's outcome was unknown.No other information is available.

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event was unable to be confirmed and it cannot be confirmed if the stent met specification, as the stent 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.It was reported that intraoperative rupture occurred during coil embolization of an unruptured aneurysm using the subject stent atlas and target coils.The patient's outcome was unknown.The risk of the reported aneurysm rupture and intracranial hemorrhage are documented in the atlas dfu, as potential adverse events which can occur as a result of these type of procedures, there was no indication of device malfunction or failure, therefore an assignable cause of anticipated procedural complication, will be assigned to the reported 'patient aneurysm rupture and 'patient intracranial hemorrhage'.This is 2 of 2 reports.

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM 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: 15749956
• MDR Text Key: 303224193
• Report Number: 3008881809-2022-00555
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• 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
• Patient Outcome(s): Other