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 Code	Embolism/Embolus (4438)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
During study procedure, the subject device retriever was used to remove the proximal face of clot, left middle cerebral artery (mca) m1 segment.Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 24 and mrs (modified rankin score) of 0.It was reported that the ent (embolization to new territory) occurred in the a2 segment of the anterior cerebral artery (aca; therefore, the second pass of thrombectomy was performed to treat ent.There were no serious adverse event or neurological deterioration reported due to the ent.The event was resolved, and the procedure was completed successfully.24 hours post procedure, the patient¿s neurological assessment showed tici of 3.The patient was discharged on day 5-7 with nihss of 4.No other information was provided.
Additional Manufacturer Narrative
Section b5 executive summary: updated.Section d lot #: updated (from unknown to 0000028082).D4 expiration date - added.H4 manufacturing date ¿ added.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not returned, therefore physical and functional tests 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 embolization to new territory (ent) occurred from mca-m1 to aca-a2 and medical intervention (2nd pass of thrombectomy) was required to treat the ent.Additional information provided by the customer indicated that the device was confirmed to be in good condition post unpacking and preparation and was prepared as per the dfu, there was no allegation against the subject device, and in spite of the ent the procedure was completed successfully (tici 3 achieved).In the physician's opinion, the cause of the ent was procedure related (tortuous anatomy and distal occlusion in m2/m3).The reported 'patient embolus' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.
Event or Problem Description
During study procedure, the subject device retriever was used to remove the proximal face of clot, left middle cerebral artery (mca) m1 segment.Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 24 and mrs (modified rankin score) of 0.It was reported that the ent (embolization to new territory) occurred in the a2 segment of the anterior cerebral artery (aca; therefore, the second pass of thrombectomy was performed to treat ent.There were no serious adverse event or neurological deterioration reported due to the ent.The event was resolved, and the procedure was completed successfully.24 hours post procedure, the patient¿s neurological assessment showed tici of 3.The patient was discharged on day 5-7 with nihss of 4.No other information was provided.Update information: mdr - received additional information on 10-dec-2020 indicated that the procedure was successfully completed with tici of 3.Based on physician¿s opinion the tortuous anatomy and distal occlusion (m2/m3) were difficulty during the procedure that could have contributed to the ent.The patient is on a rehab facility with mrs (modified rankin score) of 5.

• 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: 10789772
• Report Number: 3012931345-2020-00183
• Device Sequence Number: 4111777
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/30/2020

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: 06/05/2021
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000028082
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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: EXCELSIOR XT-27 (STRYKER).; FLOWGATE² BALLOON GUIDE CATHETER (STRYKER).; TERUMO GT 0.016 GUIDEWIRE.; EXCELSIOR XT-27 (STRYKER); FLOWGATE² BALLOON GUIDE CATHETER (STRYKER); TERUMO GT 0.016 GUIDEWIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR