MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30150

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/09/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during right aca (anterior cerebral artery) aneurysm stent assisted embolization case.Punctured through right femoral artery, delivered and deployed the stent (subject device) to the lesion successfully.When retracted the delivery wire, resistance was encountered and the operator tried several times and finally retracted it, but under dsa (digital subtraction angiography) the stent (subject device) was found deformed severely, and a 2.5mm developed segment of the delivery wire was left inside the stent (subject device).Then the operator continued the coil embolization to finish the procedure.The procedure was completed successfully.

Event Description

It was reported that during right aca (anterior cerebral artery) aneurysm stent assisted embolization case.Punctured through right femoral artery, delivered and deployed the stent (subject device) to the lesion successfully.When retracted the delivery wire, resistance was encountered and the operator tried several times and finally retracted it, but under dsa (digital subtraction angiography) the stent (subject device) was found deformed severely, and a 2.5mm developed segment of the delivery wire was left inside the stent (subject device).Then the operator continued the coil embolization to finish the procedure.The procedure was completed successfully.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 was after delivering the stent to the lesion, the stent was deployed successfully, while retracting the delivery wire, resistance was encountered and the operator had to try several times to retract, finally it was retracted but under dsa (digital subtraction angiography) the stent was found deformed severely, and a 2.5mm developed segment of the delivery wire was left inside the stent.It was also reported the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that 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 this complaint.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM 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: 15126795
• MDR Text Key: 296842357
• Report Number: 3008881809-2022-00373
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: 23282425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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: 8F GUIDER (STRYKER).; SL - 10 CATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: Asian