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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject stent retriever was deployed in the target vessel and strong resistance was encountered while pulling into the micro catheter lumen.The subject retriever was unable to be pulled into the micro catheter lumen and therefore, both devices were successfully and completely removed from the patient's anatomy.On removal of the subject retriever, clots were confirmed at the tip.Post operative imaging showed improved perfusion with thrombolysis in cerebral infarction (tici) score of 3.Procedure was completed without clinical consequences to the patient.
Additional Manufacturer Narrative
Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.On initial inspection, the device was returned within an axs catalyst catheter.There was no packaging returned for this device.On visual/microscopic inspection, the retriever was extended from the distal end of the catheter with dried blood noted to the retriever.There was some slight bending/kinking noted to the distal end of the retriever core wire.On functional testing, the retriever was removed from the catheter without difficulty.A patency mandrel was advanced, and some slight resistance was met at the location of the deformation.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 is probable that the device sustained some damage/kink as a result of the difficulty to withdraw the retriever.An assignable cause of procedural factors will be assigned to the reported difficult/unable to withdraw retriever and to the analyzed retriever core wire kinked, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, the subject stent retriever was deployed in the target vessel and strong resistance was encountered while pulling into the micro catheter lumen.The subject retriever was unable to be pulled into the micro catheter lumen and therefore, both devices were successfully and completely removed from the patient's anatomy.On removal of the subject retriever, clots were confirmed at the tip.Post operative imaging showed improved perfusion with thrombolysis in cerebral infarction (tici) score of 3.Procedure was completed without clinical consequences to the patient.

• 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: 10924494
• Report Number: 3012931345-2020-00206
• Device Sequence Number: 1429642
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/16/2021

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: 10/23/2021
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: 0000035006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 03/16/2021
• 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 CATHETER (STRYKER); AXS CATALYST 6 CATHETER (STRYKER)