MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 3 reports.The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure using the subject device (retriever) along with other devices (distal access catheter and long sheath), the patient's vessel rupture d in m2 branch and led to hemorrhage in which resulting in a serious injury and required medical intervention.No other information was provided.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.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 was no allegation of device malfunction against the subject device.Based upon medical review, the harms observed in this complaint are anticipated in nature as per the device risk assessment.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.
Event or Problem Description
It was reported that during procedure using the subject device (retriever) along with other devices (distal access catheter and long sheath), the patient's vessel rupture d in m2 branch and led to hemorrhage in which resulting in a serious injury and required medical intervention.No other information was provided.
Additional Manufacturer Narrative
The device history record review confirms there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 event since review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during procedure using the subject device (retriever) along with other devices (distal access catheter and long sheath), the patient's vessel rupture d in m2 branch and led to 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.

• Brand Name: TREVO XP PROVUE 3MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10023195
• Report Number: 3012931345-2020-00071
• Device Sequence Number: 2937286
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• PMA/510(K) Number: K133464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2021
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000026640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/10/2020; 07/07/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 06/18/2020; 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LS¿ LONG SHEATH (STRYKER); AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LS¿ LONG SHEATH (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 69 YR