MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO 14 PRO MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90231

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

Patient Problems Headache (1880); Hematoma (1884); Hemorrhage, Subarachnoid (1893); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, functional and visual analysis were not 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.Additional information indicated that the anatomy was tortuous and the physician did not allege any malfunction or non-conformance against the device.The reported patient hematoma, patient intracranial hemorrhage, patient pseudoaneurysm, patient vessel dissection, and patient headache serious are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.This is the 2 of 2 reports.The subject device is not available to the manufacturer.

Event Description

The ¿delayed rebleeding from pseudoaneurysm after mechanical thrombectomy using stent retriever due to small artery avulsion confirmed by open surgery¿ article states that the patient was presented with right hemiplegia and global aphasia.Imaging revealed occlusion of the m2 segment of the left middle cerebral artery with subtle acute ischemic change in this territory.Intravenous thrombolysis was given and mechanical thrombectomy were performed with the subject stent retriever.Successful revascularization was finally achieved with a single pass of the stent retriever.During retrieval of the stent retriever from the patient¿s body, significant deviation of the vessel occurred around middle cerebral artery inside the patient's anatomy.Anti- coagulation was initiated after confirming resolution of a small amount of post-procedural sub arachnoid hemorrhage 1 day after the procedure.However, 4 days after the procedure, the patient complained of headache and computed tomography and angiography revealed a massive sylvian hematoma with de novo formation of a small pseudoaneurysm at the site where the stent retriever was deployed.Open surgery by craniotomy and superficial temporal artery to mca bypass was performed.Surgery revealed a small artery avulsion at this site.The lesion was closed by microsurgical suturing.Three month-post-procedure, the patient remained dependent with severe aphasia and right hemiparesis.No further information is available.According to the physician, the adverse events were related to the subject stent.

• Brand Name: TREVO 14 PRO MICROCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9587153
• MDR Text Key: 183765126
• Report Number: 3012931345-2020-00006
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00815742002317
• UDI-Public: 00815742002317
• Combination Product (y/n): N
• PMA/PMN Number: K131437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90231
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR