MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40210

Device Problem Premature Activation (1484)

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

Event Date 10/16/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during left pcoma (posterior communicating artery) aneurysm embolization case when delivered the stent (subject device) through the catheter it could not be advanced any more even after several tries.Withdrew the stent (subject device) system out of microcatheter and then it deployed in proximal of catheter.The physician replaced it with a new device and continued the procedure without 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 sdw (stent delivery wire) was returned within the introducer sheath, the tip of the introducer sheath was damaged, the distal tip of the sdw had been broken/fractured from the proximal ro marker band and not returned, the sdw was kinked, and the stent was not returned.A functional test was unable to perform due to condition of returned device.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 events can be confirmed based on the results of the device analysis.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that, flushed and delivered stent through sl-10 and when it reached middle of microcatheter, the stent could not be advanced any more even after several tries.Withdrew the stent system out of microcatheter and then the stent deployed in proximal of sl-10.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 and continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was described as 'severely tortuous'.The device was returned, and the tip of the introducer sheath was damaged, the sdw was kinked and broken fractured, the damage noted is indicative of the reported event.It is probable that th4e device was damaged during use causing the reported difficulty to advance the stent and the subsequent premature stent deployment.An assignable cause of procedural factors will be assigned to the reported ¿stent difficult/unable to advance or pullback through catheter¿ and ¿stent deployed prematurely during use¿ and to the analyzed ¿stent introducer sheath distal tip damaged¿, ¿sdw broken/fractured during use¿ and ¿sdw kinked/bent¿, 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 left pcoma (posterior communicating artery) aneurysm embolization case when delivered the stent (subject device) through the catheter it could not be advanced any more even after several tries.Withdrew the stent (subject device) system out of microcatheter and then it deployed in proximal of catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 4.0MM 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: 15740252
• MDR Text Key: 307062574
• Report Number: 3008881809-2022-00550
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40210
• Device Lot Number: 23309017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2021
• 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
• Treatment: 6F GUIDE CATHETER (STRYKER); ATLAS STENT (STRYKER); SL-10 CATHETER (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER); TARGET COILS (STRYKER); XT-17 CATHETER (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: Asian