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

Catalog Number M003EZAS45210

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during an aneurysm embolization case, the operator used stent (subject device) to assist the coil embolization.After placed the microcatheter to the lesion, the stent (subject device) was delivered to the lesion and prepared to be deployed.While withdrawing the microcatheter to deploy the stent (subject device), the stent (subject device) was migrated from target lesion site where it was deployed and was not able to cover the aneurysm completely.So the operator withdrew the stent (subject device) together with the microcatheter out and deployed the stent (subject device) on the table.The physician replaced it with a new device and continued the procedure without any clinical consequences to the patient.

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 mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent was found to be deployed and returned inside the syringe, the stent was found to be deformed, the sdw (stent delivery wire) was found to be kinked/bent, the introducer sheath was not returned, and the microcatheter was not returned.A functional test was not performed as the returned stent was found to be deployed.The reported 'stent dislodged/migrated' could not be confirmed; however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on functional and visual inspection.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.Addition 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 prior to use on the patient.The stent delivery system was flushed with saline prior to use (initial flush) and continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was described as 'severely tortuous'.An excelsior sl-10 microcatheter was used during the procedure and the same sl-10 microcatheter was used to finish the procedure.It was reported that 'after placed the microcatheter to the lesion, the stent was delivered to the lesion and prepared to be deployed.While withdrawing the microcatheter to deploy the stent, the stent was migrated together with the microcatheter, and the stent was not able to cover the aneurysm completely.So, the operator withdrew the stent together with the microcatheter out and deployed the stent on the table'.As per the event description, the returned stent was fully deployed on the operating room table.The deployed stent was noted to be deformed at the distal (open cell) end.The introducer sheath was not returned for analysis and the stent delivery wire (sdw) was returned and was kinked/bent.The as reported code as well as the as analyzed codes listed in the grid below 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 factors and/or anatomical factors encountered during use.

Event Description

It was reported that during an aneurysm embolization case, the operator used stent (subject device) to assist the coil embolization.After placed the microcatheter to the lesion, the stent (subject device) was delivered to the lesion and prepared to be deployed.While withdrawing the microcatheter to deploy the stent (subject device), the stent (subject device) was migrated from target lesion site where it was deployed and was not able to cover the aneurysm completely.So the operator withdrew the stent (subject device) together with the microcatheter out and deployed the stent (subject device) on the table.The physician replaced it with a new device and continued the procedure without any 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: 12738568
• MDR Text Key: 279608487
• Report Number: 3008881809-2021-00459
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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: 22423598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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 MANUFACTURER).; SL-10 MICROCATHETER (STRYKER MANUFACTURER)
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: Asian