MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Catalog Number	90186
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the thrombectomy procedure on (b)(6) 2020, the patient experienced hemorrhage as identified as parenchymatous hematoma 2.It is noted that the adverse event has possibly relationship to the subject study retriever device.No further information is available.
Additional Manufacturer Narrative
This is 1 of 2 reports.The subject device is unavailable to manufacturer.
Additional Manufacturer Narrative
Although the dhr (device history review) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 during a clinical study, a serious adverse event occurred: hemorrhage ph2 (parenchymatous hematoma 2).Good faith effort attempts to contact the person(s) with investigation information (hospital or surgeon in this case) concluded that no additional information can or will be provided; customer / sales rep confirmed that no further information will be released by the hospital or surgeon.Therefore, further attempts will be discontinued at this time.Should any information become available that could potentially impact the current assessment decision of this record and/or the root cause of the investigation, the record will be reopened to incorporate and assess the information accordingly.  the reported 'patient hemorrhage, blood loss with sequalae' 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, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during the thrombectomy procedure on (b)(6) 2020, the patient experienced hemorrhage as identified as parenchymatous hematoma 2.It is noted that the adverse event has possibly relationship to the subject study retriever device.No further information is available.
Additional Manufacturer Narrative
Section b5 executive summary: updated.Section d4 expiration date: updated.Section h4 manufacturing date: updated.Section d -product long description/ catalog # search/ catalog #/ lot# /gtin - corrected.Section g pma/510(k) or bla #: corrected.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 during a clinical study, a serious adverse event occurred: sub arachnoid hemorrhage (sah) at the left sylvian.The reported patient intercranial hemorrhage 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, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during the thrombectomy procedure on (b)(6) 2020, the patient experienced hemorrhage as identified as parenchymatous hematoma 2.It is noted that the adverse event has possibly relationship to the subject study retriever device.No further information is available.Updated: further reviewing from medical safety team indicated that the patient experienced sub arachnoid hemorrhage (sah) at the left sylvian.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17078367
• Report Number: 3012931345-2023-00127
• Device Sequence Number: 14000451
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143077
• 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,Followup
• Report Date (Section B): 09/08/2023

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: 09/29/2021
• Device Catalogue Number: 90186
• Device Lot Number: 0000033737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 08/14/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/13/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALYST 5F (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown