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

Catalog Number M003EZAS30150

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during middle cerebral artery mca aneurysm case, after the first segment of the subject stent was pushed out from the microcatheter, it could not be pushed any more even after several tries.The operator then withdrew the delivery system and the stent system out together.The procedure was completed successfully by replacing the subject device.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.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the stent was returned in a deployed state.The stent delivery wire sdw was kinked in 3 locations, 152cm, 168cm and 175cm from the proximal end of the wire.The sdw distal tip/end was seen to be kinked.There were no anomalies noted to the stent and all 6 markers were present.The stent introducer sheath was not returned.Functional inspection was unable to perform as stent was returned in a deployed state.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 complaint code was unable to be confirmed as the stent was returned already deployed per the follow-up good faith effort gfe process.The analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the returned sdw part of the subject stent system.Additional information received indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the tortuosity of the patients anatomy was described as 'moderately tortuous'.It is reported that 'the operator used stryker microcatheter to deliver subject stent and after the first segment of the stent was pushed out from microcatheter, it could not be pushed any more even after several tries.The operator then withdrew the delivery system and the stent system out together and used other stent in same catalog to finish the procedure'.It is reported in the follow-up gfe process that the same microcatheter was used to finish the procedure.On this occasion it is likely that the delivery system (the microcatheter) along with the partially deployed stent was removed from the patient.The physician then fully deployed the stent outside of the patient and re-inserted the sl-10 microcatheter.This is aligned with the updated product condition which states that 'the stent will be returned with condition of deployed but it was not deployed prematurely during the procedure inside patient's body'.After removal the physician attempted to deploy the stent on the table (outside the patient's body).There was no resistance noted by the physician when advancing the stent through the microcatheter which suggest that transfer of the stent into the microcatheter was not an issue.The physician did not feel that the anatomy and/or location of the intended area of treatment may have contributed to the reported event.The stent was returned for analysis in a deployed condition.The stent was noted to be undamaged and the 3 marker bands were present on both ends of the returned stent.The introducer sheath was not returned for analysis.Finally, the stent delivery wire (sdw) was returned and was noted to be kinked/bent at multiple locations along it's length, primarily towards the distal end of the wire.This damage to the sdw is likely to have occurred during the user's several attempts to fully deploy the stent from the distal end of the microcatheter lumen into the patient.The as reported event of 'stent partial deployment' and the as analyzed event of 'sdw kinked/bent' will therefore 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.

Event Description

It was reported that during middle cerebral artery mca aneurysm case, after the first segment of the subject stent was pushed out from the microcatheter, it could not be pushed any more even after several tries.The operator then withdrew the delivery system and the stent system out together.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

• 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: 18086417
• MDR Text Key: 328498424
• Report Number: 3008881809-2023-00535
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: 23832075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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: SL 10 MICROCATHETER (STRYKER)
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: Asian