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

Catalog Number M003EZAS45210

Device Problem Premature Activation (1484)

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

Event Date 09/04/2022

Event Type  malfunction  

Event Description

It was reported that during internal carotid artery (ica) aneurysm stent assisted embolization case, physician used a microcatheter to deliver subject stent.During the delivery, the subject stent deployed in lumen of catheter and unable to be withdrawn.The subject stent was extracted along with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

The device is not available to the manufacturer.

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 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 event cannot be confirmed that the device met specification, as the device was not returned.It was reported that during the delivery, the subject stent deployed in lumen of the microcatheter, and could not be withdrawn.So the operator took the microcatheter out and took the stent out, and used new stent to finish the procedure.Additional information states that the patients anatomy was moderately tortuous and the same microcatheter was used to finish the procedure.As the device was not returned for analysis and a review of all available information, fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.

Event Description

It was reported that during internal carotid artery (ica) aneurysm stent assisted embolization case, physician used a microcatheter to deliver subject stent.During the delivery, the subject stent deployed in lumen of catheter and unable to be withdrawn.The subject stent was extracted along with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical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 - 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: 15741438
• MDR Text Key: 307290246
• Report Number: 3008881809-2022-00553
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 23402114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: Asian