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 Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a thrombectomy procedure for an ic(internal carotid) occlusion, the retriever (subject device) was deployed from m1 to distal m2 at a confirmed occlusion of m1 distal (middle cerebral artery).The physician was not able to remove the retriever from the vessel, the device cut into the vessel and the stent portion of the device was left inside the patient's body.The physician performed a craniotomy to remove the lodged stent portion, but was unsuccessful and subsequently stopped the procedure.Clipping was performed the following day and it was reported that the presenting condition of ic infarction worsened after procedure.No further information is available.
Event or Problem Description
It was reported that during a thrombectomy procedure for an ic(internal carotid) occlusion, the retriever (subject device) was deployed from m1 to distal m2 at a confirmed occlusion of m1 distal (middle cerebral artery).The physician was not able to remove the retriever from the vessel, the device cut into the vessel and the stent portion of the device was left inside the patient's body.The physician performed a craniotomy to remove the lodged stent portion, but was unsuccessful and subsequently stopped the procedure.Clipping was performed the following day and it was reported that the presenting condition of ic infarction worsened after procedure.No further information is available.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use, the device was prepared per the dfu, the physician allowed sufficient time for the clot to integrate into the retriever and that the patients anatomy was highly tortuous.The additional information also indicated that the marksman mc was used with the trevo retriever.The use of the marksman mc with the retriever has not been established and the performance of the retriever may be impacted as a result, as stated in the device dfu.Additionally, information provided indicates that when deploying the retriever, rather than retracting the microcatheter while applying gentle forward force to the retriever to deploy the shaped section as per the device directions for use (dfu), the physician advanced the microcatheter during deployment.Based on the information available, an assignable cause of use error was assigned to the reported event of difficulty to remove retriever.Although craniotomy was performed to surgically remove the retriever and thrombus, the physician's inability to remove the retriever and the device fragment (retriever shaped section) being left inside patient is attributed to have been caused by the reported vessel dissection.Patient vessel dissection and the reported worsening of the presenting condition of stroke post procedure are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was also assigned to this event.

• 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: 8520628
• Report Number: 3012931345-2019-00037
• Device Sequence Number: 1501677
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 0000014453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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: 3MAX MICROCATHETER (MEDICOS HIRATA); 9FR OPTIMO GUIDE CATHETER(TOKAI); MARKSMAN MICROCATHETER(MEDTRONIC); REBAR MICROCATHETER(MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 78 YR