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	Intracranial Hemorrhage (1891)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the dhr 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 returned.Therefore, visual and functional analysis were not 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.The reported 'patient intracranial hemorrhage' is a known and anticipated complication to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of 'anticipated procedural complication' will be assigned to this event.The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during thrombectomy procedure at the basilar artery, first pass was performed with the subject retriever and second pass was performed with another company's stent retriever.The next day post procedure, computed tomography scan was performed and intracranial hemorrhage was noted inside the patient's anatomy.The medical treatment given to the patient is unknown.The physician confirmed that the subject retriever performed as intended during the procedure and the reason for the intracranial hemorrhage is unknown.No further information is available.
Event or Problem Description
It was reported that during thrombectomy procedure at the basilar artery, first pass was performed with the subject retriever and second pass was performed with another company's stent retriever.The next day post procedure, computed tomography scan was performed and intracranial hemorrhage was noted inside the patient's anatomy.The medical treatment given to the patient is unknown.The physician confirmed that the subject retriever performed as intended during the procedure and the reason for the intracranial hemorrhage is unknown.No further information is available.
Additional Manufacturer Narrative
The subject device was not returned.Therefore, visual and functional analysis were not performed.Although the dhr 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 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 indicated that the physician denied causal relationship with the subject retriever on reported intracranial hemorrhage(ich), as intracranial hemorrhage(ich) was caused by natural bleeding (hemorrhagic infarction) due to postoperative cerebellar infarction.The reported 'patient intracranial hemorrhage' is a known and anticipated complication to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of 'anticipated procedural complication' will be assigned to this event.

• 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: 9806598
• Report Number: 3012931345-2020-00038
• Device Sequence Number: 16820383
• 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): 03/26/2020

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 Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: STENT RETRIEVER(UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR