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

Catalog Number M003EZAS30150

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported that during a cerebral aneurysm procedure, while retrieving the delivery wire after the subject stent deployment at the mca, the delivery wire got stuck in the strut of the subject stent and was deviated from the aneurysm neck.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during a cerebral aneurysm procedure, while retrieving the delivery wire after the subject stent deployment at the mca, the delivery wire got stuck in the strut of the subject stent and was deviated from the aneurysm neck.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent delivery wire was found to be kinked/bent.The stent was found to be deployed and not returned.(the stent was used in the procedure, and the procedure was completed successfully as per the event description).Functional inspection was unable to perform as the stent was found to be deployed and not returned.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 codes were undeterminable as the stent was not returned for analysis.The stent delivery wire (sdw), which was the only part of the device returned, did not meet specifications when received for complaint investigation based on visual inspection.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.The stent delivery system was flushed with saline (initial flush) prior to use and continuous flush was also set up and maintained throughout the clinical procedure.The tip of the introducer sheath was reported to be completely inserted into the hub of an unspecified microcatheter prior to transfer.The rhv was loosened when inserting the sheath and tightened properly so that it would not move after insertion (of the sheath).The rhv was also opened sufficiently to allow advancement of the stent through without causing damage.It was reported that 'when removing the delivery wire after stent deployment, the delivery wire got caught in the stent strut and deviated from the aneurysm neck'.The sdw was retrieved 'as normal' and no additional stent was required at the target aneurysm site ('was the new stent deployed in the target site? - as stated, "the new atlas was not opened nor the other company's stent').There were no adverse consequences to the patient.The stent was not returned for analysis as it had been deployed in the patient per the event description.The introducer sheath was also not returned for analysis.The sdw was returned and was noted to be kinked/bent.Based on the event description, it is possible that the damage noted to the sdw occurred when it was being removed after stent deployment.The as reported codes will be assigned undeterminable as the stent was deployed in the patient and was not available for analysis.The as analyzed code of "sdw kinked/ bent" will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

• 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: 13079450
• MDR Text Key: 283840891
• Report Number: 3008881809-2021-00550
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: 22911975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• 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
• Patient Age: 45 YR
• Patient Sex: Female