MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0300150

Device Problem Fracture (1260)

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

Event Date 07/14/2022

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/microscopic inspection, the stent was found to be deployed and not returned.The operator deployed it on the table after the procedure.The stent delivery catheter was found to be kinked/bent.The tip of the stent stabilizer was found to be broken/fractured.The stent stabilizer was found to be kinked/bent.During functional inspection, stent stabilizer/guidewire friction functional testing passed.The demo guidewire was advanced through without difficulties.The stent stabilizer/guidewire friction event was not confirmed during the analysis.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 code 'stent stabilizer/guidewire friction' was not confirmed during functional testing.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicates that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was described as 'moderately tortuous' and the percentage calcification at the lesion was reported as 95%.The physician felt that the anatomy and/or location of intended area of treatment may have contributed to the reported event.It was reported that 'when delivered the stent along with guidewire, big resistance was encountered at cavernous sinus segment and the stent could not be advanced even after several tries'.The stent was not returned for analysis (had been deployed outside the patient¿s body on purpose).The stent stabilizer was inspected and was kinked/bent, and the distal tip of the stabilizer was broken/fractured.There was no friction noted during the stent stabilizer/guidewire friction functional test.The stent delivery catheter (delivery catheter outer body) was also returned and was noted to be kinked/bent.The as reported ¿stent stabilizer/guidewire friction' and the as analyzed ¿stent delivery catheter kinked/bent¿, ¿stent stabilizer kinked/bent¿ and ¿stent stabilizer broken/fractured during use¿ will be assigned procedural factors.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

Analysis of the returned device found that the the distal tip of the subject stent stabilizer was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: WINGSPAN 3.0MM 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: 15786986
• MDR Text Key: 307585577
• Report Number: 3008881809-2022-00567
• 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: 11/14/2022

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: M003WE0300150
• Device Lot Number: 23376846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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: ENVOY GUIDING CATHETER (CODMAN); GUIDEWIRE (UNKNOWN)
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian