MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90184
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during one left mca (middle cerebral artery) acute occlusion procedure, when delivering the guider to the left ica (internal carotid artery) c1 tail, then delivered catalyst under the guiding of microcatheter and synchro guidewire to icac7.Flushed and delivered a subject retriever but resistance was encountered while advancing the subject retriever in microcatheter.Tried to deliver it to the thrombus and then withdrew the microcatheter to deploy the subject retriever, and after waiting for 5 minutes, the subject retriever was not expanded as expected.The subject retriever was withdrawn, and it was found to be deformed.The subject retriever was replaced with another new retriever to continue the procedure successfully.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Additional Manufacturer Narrative
D4 expiration date - added.D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached ¿ updated.H4 manufacturing date ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual of the subject retriever device revealed that the insertion tool was kinked/bent.The retrieved coils and the retriever shaped section were damaged.Functional inspection was performed as the insertion tool was flushed, and the retriever was advanced with some resistance experienced.The retriever advanced through the demo trak21 catheter without difficulties.The reported complaint could not be confirmed as the event is procedure/patient related.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 received indicated the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.During analysis, the insertion tool was found to be kinked/bent the retriever coils were found to be damaged and the shaped section was found to be damaged.The device was flushed and was advanced with friction going thru the insertion tool.It is probable that the insertion tool was damaged during the procedure.As a result, the damaged insertion tool could have caused damage to the device during advancement into the microcatheter and may have contributed to the reported stent deployment issue.An assignable cause of procedural factors will be assigned to the reported 'retriever difficult/unable to go through catheter shaft, retriever shaped section will not fully open inside vessel and retriever shaped section damage' and the reported as analyzed ¿retriever insertion tool kinked/bent', 'retriever coils damaged', 'retriever shaped section damage' and 'retriever difficult/unable to be advanced out of insertion tool' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during one left mca (middle cerebral artery) acute occlusion procedure, when delivering the guider to the left ica (internal carotid artery) c1 tail, then delivered catalyst under the guiding of microcatheter and synchro guidewire to icac7.Flushed and delivered a subject retriever but resistance was encountered while advancing the subject retriever in microcatheter.Tried to deliver it to the thrombus and then withdrew the microcatheter to deploy the subject retriever, and after waiting for 5 minutes, the subject retriever was not expanded as expected.The subject retriever was withdrawn, and it was found to be deformed.The subject retriever was replaced with another new retriever to continue the procedure successfully.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TREVO 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: 16518777
• Report Number: 3012931345-2023-00039
• Device Sequence Number: 3302068
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/11/2023

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: 11/14/2023
• Device Model Number: 90184
• Device Catalogue Number: 90184
• Device Lot Number: 0000090983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8F GUIDER SOFT TIP (STRYKER); CATALYST 6 (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TREVO PRO 18 MICROCATHETER (STRYKER)
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: Asian