MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - CE; CATHETER, PERCUTANEOUS

Catalog Number M003IC060132A0

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 2 of 3 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during procedure using the subject device (distal access catheter) along with other devices (retriever and long sheath), the patient's vessel ruptured 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 (distal access catheter) along with other devices (retriever and long sheath), the patient's vessel ruptured 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 (b)(6) 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

B5 executive summary - updated additional information.D4: lot #: updated.D4 expiration date - added.H4 manufacturing date ¿ added.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 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 additional information, 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 catheter (subject device catalyst) into the m1-segment, so that during the threombectomy, it was positioned within the cavernous segment of the ica.This caused a suboptimal angle of force during the pulling of the stent retriever.These two reasons might have facilitated the rupture.While the reported patient harms are anticipated in nature and are listed as so in the dfu, it cannot be definitively determined if the reported device difficulty engaging target vessel, caused or contributed to the adverse events.An assignable cause of undeterminable will be assigned to the investigation, a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

• Brand Name: AXS CATALYST 6 .060IN ID X 132CM - 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: 10023194
• MDR Text Key: 189974741
• Report Number: 3008881809-2020-00132
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K183463
• 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: 12/03/2021
• Device Catalogue Number: M003IC060132A0
• Device Lot Number: 21990788
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS INFINITY LS¿ LONG SHEATH (STRYKER); TREVO XP PROVUE RETRIEVER 3X20 (STRYKER)
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 69 YR