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 Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during the study procedure, the intracranial carotid dissection was occurred.Therefore, stenting of carotid dissection was performed along with medical management in response to the patient¿s dissection.The procedure was completed, and the event was resolved with the thrombolysis in cerebral infarction (tici) score of grade 2a.The patient was discharged with institute of health stroke scale (nihss) of 13.It¿s indicated that there was relationship between the event to the subject device (retriever) and index procedure.No other information was provided.
Event or Problem Description
It was reported that during the study procedure, the intracranial carotid dissection was occurred.Therefore, stenting of carotid dissection was performed along with medical management in response to the patient¿s dissection.The procedure was completed, and the event was resolved with the thrombolysis in cerebral infarction (tici) score of grade 2a.The patient was discharged with institute of health stroke scale (nihss) of 13.It¿s indicated that there was relationship between the event to the subject device (retriever) and index procedure.No other information was provided.
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 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.The reported 'patient vessel dissection' is known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during the study procedure, the intracranial carotid dissection was occurred.Therefore, stenting of carotid dissection was performed along with medical management in response to the patient¿s dissection.The procedure was completed, and the event was resolved with the thrombolysis in cerebral infarction (tici) score of grade 2a.The patient was discharged with institute of health stroke scale (nihss) of 13.It¿s indicated that there was relationship between the event to the subject device (retriever) and index procedure.No other information was provided.Update information: based on additional information received on 03-august-2022 from the medical safety indicated that the initial reported dissection (in ibm edc) has been cancelled in medidata edc.It means that the dissection was initially reported but later the site considered there was no ae to report.
Additional Manufacturer Narrative
B1 averse event/product problem: corrected :no adverse event.B2 outcomes attributed to ae : corrected : no outcomes attributed to ae.H1 type of reportable event: corrected : no serious injury.Device code grid : corrected: no apparent adverse event.F10 / h6 health effect - clinical code: corrected to: no health consequences or impact.F10 / h6 health effect - impact code: corrected to health impact code grid.B5 executive summary: updated.Based on additional information received on 03-august-2022 from the medical safety indicated that the initial reported dissection (in ibm edc) has been cancelled in medidata edc.It means that the dissection was initially reported but later the site considered there was no ae to report.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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
• 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: 10293836
• Report Number: 3012931345-2020-00104
• Device Sequence Number: 2655013
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 08/09/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 08/03/2022
• Initial Report FDA Received Date: 07/19/2020
• Supplement Report FDA Received Date: 08/25/2020; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BALLOON GUIDE CATHETER (STRYKER); BALLOON GUIDE CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Unknown