MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS INFINITY LS 90CM - CE; CATHETER, PERCUTANEOUS

Catalog Number GEN-10476-90

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

Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

This is 3 of 3 report.The subject device is unavailable to manufacturer.

Event Description

It was reported that during procedure using the subject device (long sheath) along with other devices (retriever, distal access catheter), the patient's vessel rupture d in m2 branch and led to subarachnoid/symptomatic intracranial hemorrhage in which resulting in a serious injury and required medical intervention.No other information was provided.

Event Description

It was reported that during procedure using the subject device (long sheath) along with other devices (retriever, distal access catheter), the patient's vessel rupture d in m2 branch and led to subarachnoid/symptomatic intracranial hemorrhage in which resulting in a serious injury and required medical intervention.No other information was provided.Update additional information: received additional information from the site on 19-june-2020 indicated that the cause of the vessel rupture is not known.First, there was a high friction during thrombectomy, most likely cause by the underlying vessel disease, presumably due to hard thrombus.Second, it was technically not possible to navigate the intermediate subject catheter into the m1-segment, so that during the thrombectomy, it was positioned within the cavernous segment of the ica (internal carotid artery).This caused a suboptimal angle of force during the pulling of the stent retriever.These two reasons might have facilitated the rupture.The rupture was treated by occluding the m1/m2 segment of the ica with balloon catheter and resolved after 10 minutes no more active extravasation was observed.The hemorrhage was stable in post-interventional control imaging.The patient¿s nihss score (national institute of health stroke scale) was slightly increased from 9 (immediately pre-interventional) to 12 (status at discharge).However, it cannot certainly estimate if this deterioration was caused by not opening the occluded vessel or by the subarachnoid hemorrhage.The vessel was left occluded.The patient¿s symptoms were stable from discharge until the 30 day follow-up.The patient was assessed having a nihss of 12 and a modified ranquin scale (mrs) of 4.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.It was reported that during the procedure, the patient's vessel ruptured and led to subarachnoid/symptomatic intracranial hemorrhage.This resulted in serious injury and required endovascular intervention (selective balloon occlusion of ruptured m2 branch).Additional information provided by the customer indicated that there were two potential contributing factors to the reported event.First, there was high friction during thrombectomy, most likely caused by the underlying vessel disease, presumably due to hard thrombus.Second, it was technically not possible to navigate the intermediate catheter (catalyst 6) into the m1 segment, so that during the thrombectomy, it was positioned within the cavernous segment of the ica.This caused a suboptimal angle of force during the pulling of the stent retriever.While the reported patient harms are anticipated in nature and are listed as such in the dfu, it cannot be definitively determined if they were caused by the subject device.An assignable cause of undeterminable will be assigned to the reported 'patient vessel perforation', patient hemorrhage, blood loss with sequelae, and patient intracranial hemorrhage' since review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

• Brand Name: AXS INFINITY LS 90CM - CE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10023197
• MDR Text Key: 189977704
• Report Number: 3008881809-2020-00133
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K152876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2021
• Device Catalogue Number: GEN-10476-90
• Device Lot Number: 12938-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); TREVO XP PROVUE RETRIEVER 3X20 (STRYKER)
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 69 YR