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

Catalog Number M003EZAS40240

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

Patient Problem Hematoma (1884)

Event Date 01/28/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a neurovascular procedure was performed on 28-jan-2024 to place the subject stent.Three hours post procedure patient suffered a right frontal intracerebral hematoma, symptom of delayed awakening.No further information is available.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure each product met specifications upon release.The subject device was not available; therefore, visual inspection as well as functional evaluation could not 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 customer reported to the international clinical program manager that "right frontal intracerebral hematoma 3 hours after the procedure".This was part of a research project titled 'comparison of permanent intracranial stenting versus no stenting in strokes secondary to refractory acute proximal vascular occlusion: a multicenter randomized controlled trial'.The as reported 'patient hematoma' is listed in the atlas stent dfu as an anticipated outcome of these types of procedures.Therefore, an assignable cause of anticipated procedural complication, will be assigned to the as reported code.

Event Description

It was reported that a neurovascular procedure was performed on (b)(6) 2024 to place the subject stent.Three hours post procedure patient suffered a right frontal intracerebral hematoma, symptom of delayed awakening.No further information is available.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM 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: 18740377
• MDR Text Key: 335770274
• Report Number: 3008881809-2024-00071
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 24313909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Male