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

Model Number M003UZAS30210

Device Problems Entrapment of Device (1212); Migration (4003)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

It was reported that during an endovascular procedure in a patient, when the physician tried to retrieve the stent delivery wire after deployment of the subject stent, the stent delivery wire caught on the subject stent creating a force that pulled the stent proximally.The delivery wire felt stuck and unable to retrieve into the microcatheter.The distal stent tines stayed in place but the proximal stent tines seemed to migrate proximally a little during retrieval of the delivery wire.The physician was ultimately able to get the delivery wire free.This caused a surgical delay of 5 min.The procedure was completed successfully.No clinical consequences were reported to the patient either due to this event or due to the surgical delay.

Manufacturer Narrative

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 distal end of the sdw was seen to be kinked.The stent and introducer sheath were not returned.(stent successfully deployed during the procedure).Functional inspection was not carried out as only the sdw was returned.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 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.It was reported that atlas's snagged after they were deployed.Additional information states that the patients anatomy was moderately tortuous, the physician feels that the anatomy and/or location of intended area of treatment may possibly have contributed to the reported event.It is probable that the sdw was kinked during use causing it to become entangled in the stent during the attempt to remove the sdw.An assignable cause of procedural factors will be assigned to the reported 'sdw stuck in stent' and 'stent dislodged/migrated', and to the analyzed 'sdw kinked/bent', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during an endovascular procedure in a patient, when the physician tried to retrieve the stent delivery wire after deployment of the subject stent, the stent delivery wire caught on the subject stent creating a force that pulled the stent proximally.The delivery wire felt stuck and unable to retrieve into the microcatheter.The distal stent tines stayed in place but the proximal stent tines seemed to migrate proximally a little during retrieval of the delivery wire.The physician was ultimately able to get the delivery wire free.This caused a surgical delay of 5 min.The procedure was completed successfully.No clinical consequences were reported to the patient either due to this event or due to the surgical delay.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA
• 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: 15802210
• MDR Text Key: 307307529
• Report Number: 3008881809-2022-00576
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382211
• UDI-Public: 07613327382211
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003UZAS30210
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: 23617239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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: BALLAST LONG SHEATH (UNKNOWN); SL-10 MICROCATHETER (STRYKER); SOFIA INTERMEDIATE CATHETER (MICROVENTION)
• Patient Age: 79 YR
• Patient Sex: Female