MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003UZAS30210

Device Problem Fracture (1260)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the procedure, after deploying the subject stent in the m2/m1 vessel the operator tried to re-cross the wire to select the other vessel for the second stent.The guidewire got stuck on to the subject stent.While trying to free the wire, the operator pulled out a portion of the subject stent.The patient¿s m1 vessel appeared to be occluded in the final run.No further information available.

Event Description

It was reported that during the procedure, after deploying the subject stent in the m2/m1 vessel the operator tried to re-cross the wire to select the other vessel for the second stent.The guidewire got stuck on to the subject stent.While trying to free the wire, the operator pulled out a portion of the subject stent.The patient¿s m1 vessel appeared to be occluded in the final run.Additional information received on 23-june-2023 confirmed that a wide neck aneurysm in the middle cerebral artery (mca) bifurcation was being treated but the procedure was not completed.The physician attempted to remove the broken section of the stent with a snare but was unsuccessful.No further information available.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the product 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.The reported event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the reported event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA
• 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: 17104766
• MDR Text Key: 316944809
• Report Number: 3008881809-2023-00294
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382211
• UDI-Public: 07613327382211
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003UZAS30210
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• 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); SYNCHRO SELECT GUIDEWIRE (STRYKER)
• Patient Outcome(s): Other; Required Intervention