MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during a thrombectomy procedure with the subject stent retriever, patient vessel perforation and dissection occurred.Physician was unable to confirm if the subject device was responsible for the patient vessel perforation and dissection.Heparin and warfarin were reversed to treat the vessel perforation and dissection and bleeding stopped.Aspiration was done with a catheter and procedure was completed successfully.One day post operation, the patient developed intercranial hemorrhage (ich) and symptomatic sub arachnoid hemorrhage (sah).Treatment for ich and sah is unknown.Patient was transferred to a rehabilitation hospital for further management.No other information is available.
Additional Manufacturer Narrative
Based on the results of the device history review (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 thrombectomy was done with trevo and aspiration catheter (3max) for the cardio embolic of left m2.During procedure, vessel perforation and dissection for which a causal relationship cannot be denied was occurred.At aug-11, intercranial hemorrhage (ph-1) and symptomatic sub arachnoid hemorrhage occurred.The reported patient vessel perforation, patient vessel dissection and patient intracranial hemorrhage, are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files, therefore an assignable cause of anticipated procedural complication will be assigned to this complaint.
Event or Problem Description
It was reported that during a thrombectomy procedure with the subject stent retriever, patient vessel perforation and dissection occurred.Physician was unable to confirm if the subject device was responsible for the patient vessel perforation and dissection.Heparin and warfarin were reversed to treat the vessel perforation and dissection and bleeding stopped.Aspiration was done with a catheter and procedure was completed successfully.One day post operation, the patient developed intercranial hemorrhage (ich) and symptomatic sub arachnoid hemorrhage (sah).Treatment for ich and sah is unknown.Patient was transferred to a rehabilitation hospital for further management.No other information is available.

• Brand Name: TREVO XP PROVUE 4MM 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: 10668078
• Report Number: 3012931345-2020-00156
• Device Sequence Number: 14201142
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132641
• 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
• Report Date (Section B): 01/12/2021

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: 12/10/2020
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000019594
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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: 3MAX ASPIRATION CATHETER (UNKNOWN); 3MAX ASPIRATION CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR