MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.5MM X 30MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E45300

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported that during left internal carotid artery (ica) aneurysm case, when delivering subject stent the ro (radiopaque) markers were not visible under digital subtraction angiography (dsa) for physician.Therefore, the subject stent was retrieved, and the procedure was completed successfully with another device.There were no clinical consequences to the patient reported as a result of this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

• Brand Name: NEUROFORM 3 EZ 4.5MM X 30MM - 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: 19101925
• MDR Text Key: 340803835
• Report Number: 3008881809-2024-00162
• 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
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EN3E45300
• Device Lot Number: 24061923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: ARTERY SHEATH (UNKNOWN); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); GUIDER SOFTIP GUIDE CATHETER (STRYKER); TARGET COIL (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: Asian