MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE RETRIEVER 4X20; CATHETER, THROMBUS RETRIEVER

Catalog Number	90182
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the thrombectomy procedure of the middle cerebral artery (mca), the stent retriever (subject device) could not be withdrawn from the patient vessel.The reported event required an aspiration catheter to remove the stent.The procedure was successfully completed with another device with no consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The retriever was returned loaded into the stryker microcatheter used during the procedure.The reported complaint was confirmed based on analysis.Visual inspection was performed on the retriever and it was observed the proximal section was protruding through the proximal end of the catheter.The retriever was jammed in the microcatheter.In addition, excessive kinks and damage was seen to the catheter shaft.The returned microcatheter was filled with procedural fluid and attempts to flush the device to remove the retriever were not successful.Functional testing could not be performed due to the damaged condition of the returned device.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.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.The reported event was confirmed, it is likely that the damage to microcatheter shaft was due to difficulty in withdrawing the retriever, therefore, a probable cause of ''caused by other' will be assigned to the reported issue.
Event or Problem Description
It was reported during the thrombectomy procedure of the middle cerebral artery (mca), the stent retriever (subject device) could not be withdrawn from the patient vessel.The reported event required an aspiration catheter to remove the stent.The procedure was successfully completed with another device with no consequences to the patient.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X20
• 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: 8498129
• Report Number: 3012931345-2019-00035
• Device Sequence Number: 1650742
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• PMA/510(K) Number: K132641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2020
• Device Catalogue Number: 90182
• Device Lot Number: 0000014454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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: ASPIRATION CATHETER(PENUMBRA)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 82