MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number	90185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that thrombectomy procedure was performed using the subject retrieval device to remove a clot in right middle cerebral artery (mca) aneurysm at m2 segment.Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 7 and mrs (modified rankin score) of 0.It was reported that during study procedure, intracranial hemorrhage new sah (subarachnoid hemorrhage) occurred within the right sylvian fissure, new 1.2cm intraparenchymal hemorrhage probably due to iatrogenic injury to vessel.The procedure was completed with the first pass and after 24 hours post procedure, the patient had (nihss) of 2.The event was not symptomatic intracranial hemorrhage (sich) and it was resolved without medical treatment to the patient.The patient was discharged on day 5-7 with nihss of 0 and mrs of 1 and on day 30 with mrs of 1.
Additional Manufacturer Narrative
Section b5: executive summary: updated.Section d4 expiration date - added.Section 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 available; therefore, a visual inspection as well as a functional evaluation 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation / prior to use on the patient and was prepared as per the dfu.The reported ¿patient hemorrhage, blood loss without sequalae¿ and ¿patient vessel perforation¿ are 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
It was reported that thrombectomy procedure was performed using the subject retrieval device to remove a clot in right middle cerebral artery (mca) aneurysm at m2 segment.Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 7 and mrs (modified rankin score) of 0.It was reported that during study procedure, intracranial hemorrhage new sah (subarachnoid hemorrhage) occurred within the right sylvian fissure, new 1.2cm intraparenchymal hemorrhage probably due to iatrogenic injury to vessel.The procedure was completed with the first pass and after 24 hours post procedure, the patient had (nihss) of 2.The event was not symptomatic intracranial hemorrhage (sich) and it was resolved without medical treatment to the patient.The patient was discharged on day 5-7 with nihss of 0 and mrs of 1 and on day 30 with mrs of 1.Update information: received additional information on 05-dec-2020 confirmed that the patient¿s vessel was perforated.There was no intervention was taken in response to the patient¿s vessel (angiographically occult).There were no issues was encountered during use of the subject device and the subject device performed as intended.

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• 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: 10997330
• Report Number: 3012931345-2020-00217
• Device Sequence Number: 11718250
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K150616
• 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: 01/08/2022
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: 0000039069
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER).; AXS INFINITY LONG SHEATH PLUS CATHETER (STRYKER).; MEDELA DOMINANT FLEX PUMP (STRYKER).; SYNCHRO 2 (STRYKER).; TREVO PRO 18 (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR