MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 4.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0400200

Device Problem Migration (4003)

Patient Problem Ischemia (1942)

Event Date 01/05/2023

Event Type  Injury  

Event Description

It was reported that during a neurovascular procedure, the subject stent was deployed at the target lesion (internal carotid artery - c2) and the distal and proximal radio opaque markers were confirmed to be spread.After deployment of the subject stent when the operator attempt to retrieve the subject stent delivery system, the distal marker was moved, resulting in shortening of the subject stent.Immediately after the shortening of the subject stent the patient's intracranial circulation became poor and patient's level decreased.An additional stent was implanted in the patient to remediate the subject stent shortening and the intracranial circulation was restored and the procedure was completed successfully.

Manufacturer Narrative

H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.On visual/microscopic inspection it was noted that the stent was found to be deployed.Stent implanted during procedure.The stent stabilizer was found to be kinked/bent.The stent stabilizer tip was found to be intact.The stent delivery catheter was found to be kinked/bent.The distal end of the stent delivery catheter was found to be flattened/crushed.Functional inspection: n/a.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 as reported 'stent dislodged/migrated' could not be confirmed as the event is procedure/patient related and the stent was not returned.The reported patient complications could not be confirmed during the analysis; however the analysis results are consistent with reported event.The device did not meet specifications when received for complaint investigation based on visual inspection.The stent was not returned for analysis.The stent delivery catheter and stent stabilizer were analysed.The stent delivery catheter was found to be flattened/crushed.The stent delivery catheter and the stent stabilizer were found to be kinked/bent.It is probable that these defects caused issues during the procedure.An assignable cause of procedural factors will be assigned to the as reported 'patient complication' , and as analyzed 'stent delivery catheter flat/crushed, stent delivery catheter kinked/bent, stent stabilizer kinked/bent, as the issues are 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.While there are a number of potential causes for the reported 'stent dislodged/migrated', because review and analysis of available information failed to identify a definitive cause and the stent was not returned, an assignable cause of undeterminable will be assigned to the as reported stent dislodged/migrated.

Event Description

It was reported that during a neurovascular procedure, the subject stent was deployed at the target lesion (internal carotid artery - c2) and the distal and proximal radio opaque markers were confirmed to be spread.After deployment of the subject stent when the operator attempt to retrieve the subject stent delivery system, the distal marker was moved, resulting in shortening of the subject stent.Immediately after the shortening of the subject stent the patient's intracranial circulation became poor and patient's level decreased.An additional stent was implanted in the patient to remediate the subject stent shortening and the intracranial circulation was restored and the procedure was completed successfully.

• Brand Name: WINGSPAN 4.0MM X 20MM - 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: 16269660
• MDR Text Key: 308439242
• Report Number: 3008881809-2023-00048
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H050001
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0400200
• Device Lot Number: 23401961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male