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

Model Number	M003UZAS45210
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the stent assisted coiling of the aneurysm, the subject stent deployed prematurely inside the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the stent assisted coiling of the aneurysm, the subject stent deployed prematurely inside the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device direction 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 stated "stent deployed inward wrong direction".The mca (middle cerebral artery) was being treated for stent assisted coil of aneurysm.A new stent, coil and microcatheter was used to finish the procedure.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 of stent deployed prematurely during use.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated h3 summary attached - updated d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated h6 method code grid - updated h6 result code grid - updated h6 conclusion code grid - updated due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the introducer sheath distal tip was found to be intact.The stent delivery wire (sdw) was found to be intact.The stent was found to be positioned in the proximal end of the introducer sheath slightly deployed.The stent was found to be intact.During functional inspection, the proximal end of the sdw was advanced into the introducer sheath distal tip and through the sheath to free the stent which was positioned in the proximal end of the introducer sheath.The stent came free with no resistance felt.The reported event is covered in the device direction 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 stent deployed prematurely during use was confirmed during the analysis based on the position of the stent in the introducer sheath when returned.The device did not meet specifications when received for complaint investigation based on analysis results.Additional information provided by the customer stated "stent deployed inward wrong direction".The mca was being treated for stent assisted coil of aneurysm.A new stent, coil and microcatheter were used to finish the procedure.Additional information also indicates the stent deployed in the microcatheter.It is most likely that due to anatomical or unknown procedural factors the stent was deployed/partially deployed in the microcatheter and then retracted fully back through the introducer sheath resulting in the stent positioning in the proximal end of the introducer sheath.The device was returned and analyzed.The stent, sdw and stent introducer sheath were found to be intact.An assignable cause of procedural factors will be assigned to the as reported and as analyzed codes stent deployed prematurely during use, and to as analyzed stent partial deployment as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that during the stent assisted coiling of the aneurysm, the subject stent deployed prematurely inside the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA
• Common Device Name: 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: 16909090
• Report Number: 3008881809-2023-00241
• Device Sequence Number: 20676370
• Product Code: NJE
• UDI-Device Identifier: 07613327382150
• UDI-Public: 07613327382150
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 11/10/2023

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 Model Number: M003UZAS45210
• Device Catalogue Number: M003UZAS45210
• Device Lot Number: 23986514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 10/27/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/01/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown