MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 2.5MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0250150

Device Problem Fracture (1260)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection found that the stent was found to be deployed and not retuned.The stent stabilizer was found to be broken/fractured.The stent delivery catheter was found to be kinked/bent and deformed.The stent was found to be intact and the dry blood was noted within the stent delivery catheter.The functional test was unable to perform as the stent was found to be deployed and not returned.The reported stent failed/unable to deploy could not be replicated however, the analysis results are consistent with the reported event.The reported stent delivery catheter deformed was confirmed during the analysis.The device did not meet specifications when received for complaint investigation based on visual inspection.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.Additional information received 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 and the patients anatomy was described as 'moderately torturous'.The device was analysed and the stent stabilizer was found to be broken fractured.It was confirmed that the physician used force to deploy the stent which caused stent stabilizer fracture.The stent was found to be deployed and not returned.The stent delivery catheter was found to be kinked/bent and deformed.The damages of the stent stabilizer and stent delivery catheter caused friction during functional test.It is probable that the moderately tortuous anatomy may have caused the damages to the device and deployment issues during the procedure.An assignable cause of procedural factors will be assigned to the reported ¿stent failed/unable to deploy and reported/analysed¿ stent delivery catheter deformed, and to the analysed codes ¿stent deployed prematurely during retraction/re-sheathing, ¿stent stabilizer broken/fractured during use,¿ stent delivery catheter kinked/bent, ¿stent stabilizer/catheter friction¿ will be assigned to this investigation., as the issues appear 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 factors during use.

Event Description

The subject device was returned for analysis, and it was discovered that the subject stent stabilizer was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: WINGSPAN 2.5MM X 15MM - 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: 17327939
• MDR Text Key: 319116201
• Report Number: 3008881809-2023-00354
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003WE0250150
• Device Lot Number: 23756892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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: 6F DAC (STRYKER); 8F GUIDE CATHETER (STRYKER); GATEWAY BALLOON (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); XT27 MICROCATHETER (STRYKER)
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: Asian