MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E40200

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/03/2023

Event Type  Injury  

Event Description

It was reported that during the left ica oa occlusion procedure, when the physician attempted to deploy the stent (subject device), it fractured.Under fluoroscopy, it was seen separated at the distal and proximal ends, in two pieces.The physician removed and replaced the delivery system.Another stent was delivered and deployed successfully inside the fractured subject stent.The procedure was completed successfully, and the patient condition is good.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

D4 expiration date - added.H4 manufacturing date ¿ added.B2 outcomes to ae ¿ updated the subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.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, a cause of undeterminable was assigned to the as reported event.

Event Description

It was reported that during the left ica oa occlusion procedure, when the physician attempted to deploy the stent (subject device), it fractured.Under fluoroscopy, it was seen separated at the distal and proximal ends, in two pieces.The physician removed and replaced the delivery system.Another stent was delivered and deployed successfully inside the fractured subject stent.The procedure was completed successfully, and the patient condition is good.

• Brand Name: NEUROFORM 3 EZ 4.0MM X 20MM - 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: 16619777
• MDR Text Key: 312055305
• Report Number: 3008881809-2023-00156
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020002/S046
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EN3E40200
• Device Lot Number: 23943408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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).; XT -27 MICROCATHETER (STRYKER).
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Race: Asian