MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 3.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0300200

Device Problem Component Missing (2306)

Patient Problems Intracranial Hemorrhage (1891); Transient Ischemic Attack (2109); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 09/01/2021

Event Type  Injury  

Event Description

It was reported that after the subject stent was successfully implanted in the right va (vertebral artery) stenosis, the system could not be removed.When the system was pulled out strongly, occlusion in the stent and bleeding in the va occurred, and the other side was also occluded.Blood flow to the ba (basilar apex) was secured by pta (percutaneous transluminal angioplasty) and stenting on the other side, but there was ischemia for a certain period of time, and the patient's health was under observation.As a result, the blood flow in the left va was restored and the ischemia was resolved.Afterwards, when the system was removed, the tip of the inner shaft was caught in the subject implanted stent, making it impossible to remove, and when the stent was finally removed by pulling hard, it was assumed that the stent was damaged, and the end of the ro (radiopaque) marker on the stopper part of the inner shaft assumed to be entangled in the stent and left behind in the stent implantation area.The patient¿s current condition is no change in neurological symptoms compared to before surgery.No other information was provided.

Manufacturer Narrative

D4 expiration date - added h3 device evaluated by mfg ¿updated h3 summary attached - updated h4 manufacturing date ¿ added due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Visual inspection of the device revealed that the stent stabilizer was found to be severely kinked/bent and the distal end of the stent stabilizer was found to be stretched.The distal 5cm section of the stabilizer was noted to be detached from the stabilizer.The stent delivery catheter was found to be flattened/crushed and deformed.The ro marker was found to be attached.During functional testing, the slight resistance was noted during the friction test.It was reported that the system could not be removed, and when it was pulled out strongly, occlusion in the stent and bleeding in the va occurred, and the other side was also occluded.Blood flow to the ba was secured by pta and stenting on the other side, but there was ischemia for a certain period of time, and the patient's health was under observation.When we checked the removal system, we could not find the tip, which may have been removed inside or outside the body.The device was returned, and it was confirmed that the distal 5cm section of the stent stabilizer had become detached and was not returned, the failure mode was able to be recreated during analysis by holding and pulling on the distal end of a demonstration stabilizer, very similar defect characteristics were noted to the demonstration device as were noted on the returned complaint device.It is probable that the stabilizer was caught on the deployed wingspan stent during the attempt to remove the delivery system, causing the reported anomalies and the separation of the stabilizer tip.An assignable cause of procedural factors will be assigned to the reported device defects and analyzed device defects as outlined in the product problem codes below, 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.The reported patient harms, while anticipated in nature for these types of procedures, it is felt that in this instance the series of events leading to the attempt to remove the stabilizer against resistance and subsequent separation of the stabilizer tip, were instrumental in causing the harm to the patient.Therefore an assignable cause of procedural factors will be assigned to the reported patient harms.

Event Description

It was reported that after the subject stent was successfully implanted in the right va (vertebral artery) stenosis, the system could not be removed.When the system was pulled out strongly, occlusion in the stent and bleeding in the va occurred, and the other side was also occluded.Blood flow to the ba (basilar apex) was secured by pta (percutaneous transluminal angioplasty) and stenting on the other side, but there was ischemia for a certain period of time, and the patient's health was under observation.As a result, the blood flow in the left va was restored and the ischemia was resolved.Afterwards, when the system was removed, the tip of the inner shaft was caught in the subject implanted stent, making it impossible to remove, and when the stent was finally removed by pulling hard, it was assumed that the stent was damaged, and the end of the ro (radiopaque) marker on the stopper part of the inner shaft assumed to be entangled in the stent and left behind in the stent implantation area.The patient¿s current condition is no change in neurological symptoms compared to before surgery.No other information was provided.

• Brand Name: WINGSPAN 3.0MM 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: 12542581
• MDR Text Key: 273660487
• Report Number: 3008881809-2021-00400
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Catalogue Number: M003WE0300200
• Device Lot Number: 22716145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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: AGOSAL14 300CM (MEDTRONIC); CHIKAI GUIDEWIRE14; AGOSAL14 300CM (MEDTRONIC); CHIKAI GUIDEWIRE14
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male
• Patient Race: Asian