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

Catalog Number	M003UZAS30210
Medical Device Problem Codes	Entrapment of Device (1212); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during stent assisted coiling aneurysm procedure, the operator deployed successfully the subject stent at the middle cerebral artery location.When attempting the transverse into the proximal end of the subject stent, resistance was felt.When the operator pulled the microcatheter back, the subject stent was dragged out of its intended position.The operator thinks the subject stent became wedged into the microcatheter along with the delivery wire.After the microcatheter was removed the subject stent was not found, and is thought to be left inside the patient's anatomy.The patient condition is unknown.No further information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.D4 lot number - updated.D4 gtin - updated.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 conducted due to the device 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 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.Additional information provided by the customer indicated that the device was prepared as per the dfu.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.It was reported that 'the operator deployed the subject stent successfully.He tried to traverse into the proximal end of the stent and felt resistance.He then tried to pull back and pulled the subject stent along with it.He believes the subject stent become wedged into the microcatheter along with the delivery wire.The catheter was pulled out of the body but the stent was lost, the physician believes inside the body'.It is believed that the 'device was entangled with the microcatheter and dragged out of its intended position'.The procedure was aborted after the catheter was removed from the patient.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during stent assisted coiling aneurysm procedure, the operator deployed successfully the subject stent at the middle cerebral artery location.When attempting the transverse into the proximal end of the subject stent, resistance was felt.When the operator pulled the microcatheter back, the subject stent was dragged out of its intended position.The operator thinks the subject stent became wedged into the microcatheter along with the delivery wire.After the microcatheter was removed the subject stent was not found, and is thought to be left inside the patient's anatomy.The patient condition is unknown.No further information is available.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• 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: 20918164
• Report Number: 3008881809-2024-00594
• Device Sequence Number: 20100854
• Product Code: QCA
• UDI-Device Identifier: 07613327382211
• UDI-Public: (01)07613327382211(17)290716(10)25076444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: 25076444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown