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

Catalog Number M003WE0300200

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problems Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 12/07/2020

Event Type  Injury  

Event Description

It was reported that after emergency transportation for acute cerebral infarction on (b)(6) 2020, mechanical thrombus recovery was performed.Although thrombus recovery was performed using a stent retriever, it was determined that the cause was dissection of blood vessels, so no further procedure was performed.The next day, (b)(6), the obstruction was suspected again, so endovascular treatment was performed.Angiography revealed that it was occluded from rt.Va, and pta (percutaneous transluminal angioplasty) was performed at the balloon catheter.After pta, blood vessels became visible, dissociation was observed from the ba (basilar apex) top, so the subject stent placement was attempted.Expanded the subject stent from rt.Pca and detained it to ba.Although the placement was successfully done, the marker which was proximal to the subject stent was not fully opened and seemed to be poorly deployed.In order to perform the additional pta, when trying to remove the subject stent system, a strong resistance was felt.However, if the subject stent system was not removed, the next treatment could not be performed, so the subject stent system could be removed by pulling with a strong force.However, since the surgeon was able to confirm a marker that should not have been seen through fluoroscopy, when he checked the removed subject stent system , it was confirmed that there was no tip on the inner body, so it was judged that the subject stent system was broken and remained inside the body.After that, the surgeon tried to remove the broken part using a snare, but as the subject stent seemed to come off, he considered the risk of bleeding and completed the procedure.No other information was provided.

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.Visual inspection of the device revealed that the stabilizer and the delivery catheter were returned separated.The stabilizer was noted to be broken/fractured at the distal end and the fractured section was not returned.The distal 36cm section of the delivery catheter was noted to be flattened along its length.The stabilizer was flushed, and blood exited.A functional test could not be performed as the stent had been deployed.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.As per the available information the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was very tortuous.The device was returned and it was confirmed that the stabilizer distal section had been detached and was not returned, the delivery catheter was flattened along its distal section causing friction during movement of the stabilizer within.It is probable that the device was damaged during navigation and manipulation through the patients anatomy causing the difficulties experienced during stent deployment and delivery system retrieval.An assignable cause of procedural factors will be assigned to the reported stent broken/fractured during use, stent difficult/unable to advance or pull back through catheter, un-retrieved device fragments, stent failed/unable to open and stent failed/unable to deploy and to the analysed stent stabilizer broken/fractured during use, stent delivery catheter flat/ crushed and stent stabilizer/catheter friction, 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.Patient vessel thrombosis is anticipated in nature, however this thrombosis is likely to have been caused by the reported events.An assignable cause of procedural factors will be assigned to the reported patient vessel thrombosis.

Event Description

It was reported that after emergency transportation for acute cerebral infarction on (b)(6) 2020, mechanical thrombus recovery was performed.Although thrombus recovery was performed using a stent retriever, it was determined that the cause was dissection of blood vessels, so no further procedure was performed.The next day, (b)(6) (today), the obstruction was suspected again, so endovascular treatment was performed.Angiography revealed that it was occluded from rt.Va, and pta (percutaneous transluminal angioplasty) was performed at the balloon catheter.After pta, blood vessels became visible, dissociation was observed from the ba (basilar apex) top, so the subject stent placement was attempted.Expanded the subject stent from rt.Pca and detained it to ba.Although the placement was successfully done, the marker which was proximal to the subject stent was not fully opened and seemed to be poorly deployed.In order to perform the additional pta, when trying to remove the subject stent system, a strong resistance was felt.However, if the subject stent system was not removed, the next treatment could not be performed, so the subject stent system could be removed by pulling with a strong force.However, since the surgeon was able to confirm a marker that should not have been seen through fluoroscopy, when he checked the removed subject stent system , it was confirmed that there was no tip on the inner body, so it was judged that the subject stent system was broken and remained inside the body.After that, the surgeon tried to remove the broken part using a snare, but as the subject stent seemed to come off, he considered the risk of bleeding and completed the procedure.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
• MDR Report Key: 11092218
• MDR Text Key: 224343994
• Report Number: 3008881809-2020-00409
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Catalogue Number: M003WE0300200
• Device Lot Number: 21653267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GATEWAY BALLOON CATHETER (STRYKER); STENT RETRIEVER (UNKNOWN MANUFACTURER); GATEWAY BALLOON CATHETER (STRYKER); STENT RETRIEVER (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Other; Required Intervention