MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number 90183

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that mechanical thrombectomy via sr (stent retriever) combination technique was performed for ais (acute ischemic stroke).Subject retriever stent was advance to the targeted site and stent was deployed successfully with full opening of the shape section of the retriever was achieved.After clot integration when the physician tried to withdraw the subject retriever, resistance was encountered and it got stuck into the supraclinoid segment of the ica (internal carotid artery).Constant tension has been applied on the stent delivery wire to loose the stent and then the stent retriever was removed with the captured clot from the patient vasculature.The surgical delay was noted as a result of the difficulties encountered with the subject devices.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that mechanical thrombectomy via sr (stent retriever) combination technique was performed for ais (acute ischemic stroke).Subject retriever stent was advance to the targeted site and stent was deployed successfully with full opening of the shape section of the retriever was achieved.After clot integration when the physician tried to withdraw the subject retriever, resistance was encountered and it got stuck into the supraclinoid segment of the ica (internal carotid artery).Constant tension has been applied on the stent delivery wire to loose the stent and then the stent retriever was removed with the captured clot from the patient vasculature.The surgical delay was noted as a result of the difficulties encountered with the subject devices.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 summary attached - updated h3 device evaluated by mfg ¿updated h4 manufacturing date ¿ added d4 expiration date - added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the delivery wire was intact.The retriever was intact.The insertion tool was not returned.Functional inspection: the retriever was inserted into a demo insertion tool, the insertion tool and demo trak 21 microcatheter were flushed.The retriever was advanced and retracted without issue.The reported defect was not confirmed during analysis.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 defect was not confirmed based on analysis of the device.The retriever device met specifications when received for complaint investigation.In the case of this complaint, it is most likely that the issue occurred due to procedural or anatomical factors during the procedure.The concurrent microcatheter was not returned with the retriever which also may have contributed to the event.This however cannot be conclusively determined.The device was returned, and a review of analysis and all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of not confirmed will be assigned to this reported issue of difficult/unable to withdraw retriever.No issue was noted with the returned retriever.

• Brand Name: TREVO XP PROVUE 3MM X 20MM
• Type of Device: 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: 12081653
• MDR Text Key: 258864177
• Report Number: 3012931345-2021-00102
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000053302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PENUMBRA BMX¿96 DELIVERY CATHETERS (PENUMBRA, INC); SOPHIA INTERMEDIATE CATHETER (MICROVENTION); TACK 21 MICROCATHETER (STRYKER); PENUMBRA BMX¿96 DELIVERY CATHETERS (PENUMBRA, INC); SOPHIA INTERMEDIATE CATHETER (MICROVENTION); TACK 21 MICROCATHETER (STRYKER)