MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40240

Device Problems Fracture (1260); Premature Activation (1484)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The stent (subject device) was returned for analysis and it was discovered that the subject stent was broken/fractured during use and had deployed prematurely during use.There were no clinical consequences reported to the patient due to this event.

Manufacturer Narrative

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 (sdw) was seen to be severely deformed (stretched), broken and kinked.The stent was seen to be deformed and the introducer sheath was not returned.Dimensional inspections showed the microcatheter id, hub id, stent length and stent od were within specification.The sdw dimensions could not be measured due to the damage.The functional inspection showed that a patency mandrel could not be advanced past 7cm from the microcatheter hub.The microcatheter was cut at this point and the deployed stent and distal part of the broken sdw were removed from 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 'stent difficult/unable to advance or pullback through catheter' could not be confirmed; 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.The device was analyzed.During device analysis the deployed stent was removed from one of the catheters with a broken segment of the sdw.Once the stent had been removed it was found to be deformed.The sdw was also found to be kinked and deformed.The introducer sheath was not returned.Its likely when the reported resistance was felt during the procedure manipulation of the device would have caused the stent to deploy within the catheter.The as analyzed (aa) codes 'stent deployed prematurely during use', 'sdw broken/fractured during use', 'sdw deformed', 'sdw kinked/bent' and 'stent deformed' as well as the as reported (ar) code 'stent difficult/unable to advance or pullback through catheter ' 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 4.0MM X 24MM 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: 15874187
• MDR Text Key: 307701259
• Report Number: 3008881809-2022-00595
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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
• Report Date: 11/28/2022

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 Expiration Date: 12/31/2022
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 20189726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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: 55 YR
• Patient Sex: Male