MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0250150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that the patient underwent angioplasty at the left middle cerebral artery (mca) segment m1 of a serious stenosis.During delivery of the stent (subject device) to the lesion, the stent could not advance at the curve of left mca m2 segment.After several failed tries the operator withdrew the stent, cut its taper tip and tried to deliver again, but it still could not reach the lesion.The operator tried to adjust several times and there was acute thrombosis.Therefore, the operator withdrew the stent, treated the patient with drug thrombolysis, and finished the procedure.There was a 3 hours procedure delay.There were no clinical consequences to the patient.

Event Description

It was reported that the patient underwent angioplasty at the left middle cerebral artery (mca) segment m1 of a serious stenosis.During delivery of the stent (subject device) to the lesion, the stent could not advance at the curve of left mca m2 segment.After several failed tries the operator withdrew the stent, cut its taper tip and tried to deliver again, but it still could not reach the lesion.The operator tried to adjust several times and there was acute thrombosis.Therefore, the operator withdrew the stent, treated the patient with drug thrombolysis, and finished the procedure.There was a 3 hours procedure delay.There were no clinical consequences to the patient.

Manufacturer Narrative

The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned device and it was observed that the delivery catheter was kinked at the distal end and the distal taper tip had been cut.During functional testing, some friction was experienced while advancing the stabilizer.The stent was deployed, the stabilizer was removed from the catheter and the stabilizer was noted to be kinked at 7cm from the distal end, corresponding with the catheter kink.The reported issues are covered in the device directions for use (dfu).As well, the risk of the reported issues is documented in the risk documentation and there are current controls to mitigate the risk of the reported issues.As per the additional information the patient¿s anatomy was moderately tortuous.According to the physician, the main cause of thrombosis is the worsening of vasospasm caused by the coarser stent system and repeated operation.It is probable that the tortuous anatomy caused the difficulty to advance the device to the target vessel, it is probable that the difficulty to advance the device and the repeated attempts and prolonged procedure caused the reported vasospasm, and thrombosis within the stent.While vasospasm and thrombosis can be anticipated in nature, it is probable that in this case they were due to the procedural factors (tortuosity and repeated operation).Therefore, an assignable cause of procedural factors will be assigned to this investigation.

• Brand Name: F/G WINGSPAN STENT SYSTEM 2.5 X 15MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8862605
• MDR Text Key: 153346133
• Report Number: 3008881809-2019-00229
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/06/2022
• Device Catalogue Number: M003WE0250150
• Device Lot Number: 21129436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNCHRO GUIDEWIRE (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR