MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 41MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90314
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 4 of 4 reports.The device is not available to the manufacturer.
Event or Problem Description
It was reported that after successful completion of the procedure when the subject retriever stent was stored in a tray , something like coating substance was found floating in the saline solution in the tray.It is unclear at what point in time this occurred.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that after successful completion of the procedure when the subject retriever stent was stored in a tray , something like coating substance was found floating in the saline solution in the tray.It is unclear at what point in time this occurred.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1: adverse event/product problem ¿ corrected - no ¿product problem¿.H1: type of reportable event ¿ corrected - no ¿malfunction¿.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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 event could not be confirmed and it cannot be determined if the device failed to meet specifications as the device was not returned.It was reported that when the devices were removed from the patient's body and stored in a tray after completion of the treatment, something like coating substance was found floating in the saline solution in the tray.Analysis confirmed that the coating substance noted after device removal, was in fact, ptfe coating of the guidewire investigated under the same parent complaint.There is no ptfe coating associated with retriever stent.An assignable cause of caused by other will be assigned to the reported "hydrophilic coating peeling', as the issue was found to be related to the guidewire.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 NXT 4MM X 41MM - US
• Common Device Name: NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT
• 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: 16269963
• Report Number: 3012931345-2023-00013
• Device Sequence Number: 14950269
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200117
• 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): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 58207
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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
• Patient Sex: Unknown