MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003UZAS30240

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/03/2023

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 successfully deploying the subject stent, the stent delivery wire could not be removed.The physician applied force in an attempt to remove the delivery wire which resulted in the proximal end of the subject stent dislodging and migrating to the a1/terminus.A clot began to form on the subject stent and integrilin was administered to the patient.The physician moved the proximal end of the subject stent back to the desired location using a guidewire.There was a 15 minute surgical delay and the patient is stable.

Manufacturer Narrative

H4 manufacturing date ¿ added d4 expiration date - added b2 outcomes attributed to ae- updated 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 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 was during the procedure, after successfully deploying the stent from the left m2 to m1, he could not remove the stent delivery wire (sdw).In an effort to remove the delivery wire, he pulled the wire harder.As a result, the proximal end of the stent dislodged and ended up in the a1/terminus.Clot began to form on the stent and integrilin was administered.He was able to move the proximal end of the stent back into place by using a guidewire with a j curve on it.Patient is ok.Minimal procedural delay was experienced.It was also reported that all products were prepped per their respective dfus, no anomalies were noted as the products were removed from their packages and continuous flush was set up and maintained during 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 the reported sdw stuck in sent and stent dislodged/migrated.The risk of the reported patient vessel thrombosis is documented in the 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 vessel thrombosis.

Event Description

It was reported that during the procedure, after successfully deploying the subject stent, the stent delivery wire could not be removed.The physician applied force in an attempt to remove the delivery wire which resulted in the proximal end of the subject stent dislodging and migrating to the a1/terminus.A clot began to form on the subject stent and integrilin was administered to the patient.The physician moved the proximal end of the subject stent back to the desired location using a guidewire.There was a 15 minute surgical delay and the patient is stable.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM 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: 16815266
• MDR Text Key: 314007950
• Report Number: 3008881809-2023-00208
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 23972243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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: SYNCHRO GUIDEWIRE (STRYKER).
• Patient Outcome(s): Required Intervention; Other