MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

Device Problems Premature Activation (1484); Physical Resistance/Sticking (4012)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

During the treatment of anterior communicating artery aneurysm, the subject stent device got stuck and could not be advanced out of the microcatheter.Upon retrieval, the subject stent detached from the delivery wire and deployed unexpectedly within the microcatheter.The subject device was removed along with the microcatheter and replaced.The procedure was completed successfully with no clinical consequences to the patient.

Event Description

During the treatment of anterior communicating artery aneurysm, the subject stent device got stuck and could not be advanced out of the microcatheter.Upon retrieval, the subject stent detached from the delivery wire and deployed unexpectedly within the microcatheter.The subject device was removed along with the microcatheter and replaced.The procedure was completed successfully with no clinical consequences to the patient.

Manufacturer Narrative

F10 / h6 medical device problem code: corrected.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned deployed within the microcatheter and the lot number of the subject stent was confirmed from its label.During visual inspection, the stent delivery wire and introducer sheath were found to be returned together.The distal tip of the introducer sheath was found kinked.The distal end of the stent delivery wire was noted to be kinked and the distal end of the stent deformed.During functional analysis, the returned microcatheter was flushed and a patency mandrel was advanced through the distal end, the returned deployed stent was deployed from the proximal end of the microcatheter.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 of stent deployed prematurely during use was confirmed during analysis.The reported stent difficult/unable to advance or pullback through catheter could not be confirmed as the stent was no longer loaded onto the stent delivery wire when it was returned for analysis.Instead it was deployed inside the lumen of the microcatheter.However, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that when prepared to use a microcatheter to deliver subject stent, the subject stent got stuck in microcatheter and could not be pushed out.Withdrew the stent back to proximal of microcatheter and then the stent detached from the delivery wire and the stent deployed in proximal of microcatheter.Additional information received from the customer indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was described as 'moderately tortuous'.The device was returned and the tip of the introducer sheath was noted to be kinked, the stent was deployed within the returned microcatheter and when removed the stent was noted to be deformed, the sdw was noted to be kinked.It is probable that the stent was damaged during transfer due to the damage to the distal tip of the introducer sheath, causing the reported difficulty to advance the stent through the microcatheter and the subsequent stent deployment within the microcatheter.An assignable cause of procedural factors will be assigned to the as reported events 'stent difficult/unable to advance or pullback through catheter' and 'stent deployed prematurely during use' and to the as analysed events 'stent introducer sheath distal tip damaged', 'sdw kinked/bent', 'stent deformed' and 'stent deployed prematurely during use', 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 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: 15708944
• MDR Text Key: 307072333
• Report Number: 3008881809-2022-00541
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 23427161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2022
• 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: EXCELSIOR SL10 MICROCATHETER (STRYKER); GUIDE CATHETER (UNKNOWN); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: Asian