MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE RETRIEVER 4X20; CATHETER, THROMBUS RETRIEVER

Catalog Number 90182

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Embolus (1830); No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that embolization to new territory was observed during withdrawal the subject device.The affected territory clot was not retrieved but fragmented.The procedure was completed with a different device.No further information is available.

Manufacturer Narrative

Executive summary- update: the thrombectomy intervention was performed with other stent retriever in response to the embolization to new territory and patient¿s current condition is fine at home.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Additional information provided by the customer indicated that embolization to new territory (m2 branch proximal to the primary occlusion) was observed during withdrawal of the subject device, thrombectomy intervention was performed with another stent retriever in response to the reported event, and the patient did not experience symptoms due to the embolization to new territory.The reported "patient embolus" is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this reported event.

Event Description

It was reported that embolization to new territory was observed during withdrawal the subject device.The affected territory clot was not retrieved but fragmented.The procedure was completed with a different device.No further information is available.Update information: received additional information stated that the thrombectomy intervention was performed with other stent retriever in response to the embolization to new territory and patient¿s current condition is fine at home.

Manufacturer Narrative

B5: executive summary - updated - received update information on 12-sep-2019 stated that the embolization located at the middle cerebral artery (mca) m2 branch.

Event Description

It was reported that embolization to new territory was observed during withdrawal the subject device.The affected territory clot was not retrieved but fragmented.The procedure was completed with a different device.No further information is available.Update information: received additional information stated that the thrombectomy intervention was performed with other stent retriever in response to the embolization to new territory and patient¿s current condition is fine at home.Update information: received update information on 12-sep-2019 stated that the embolization located at the middle cerebral artery (mca) m2 branch.

Manufacturer Narrative

Section b1 : adverse event/product problem: corrected to no adverse event/product problem: section b2: outcomes attributed to ae: corrected to no other serious.Information received on 5-mar-2020 clarified that that there was no adverse event (embolization to new territory).Since there was no reported malfunction of the device that could have caused or contributed to the reported event, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with the new awareness date of on 5-mar-2020.In addition, the device did not cause or contribute to any adverse event.Nor was it related to a malfunction or deterioration in the characteristics or performance of the device or labeling issues.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that embolization to new territory was observed during withdrawal the subject device.The affected territory clot was not retrieved but fragmented.The procedure was completed with a different device.No further information is available.Update information: received additional information stated that the thrombectomy intervention was performed with other stent retriever in response to the embolization to new territory and patient¿s current condition is fine at home.Update information: received update information on 12-sep-2019 stated that the embolization located at the middle cerebral artery (mca) m2 branch.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X20
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8860101
• MDR Text Key: 153243840
• Report Number: 3012931345-2019-00067
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2021
• Device Catalogue Number: 90182
• Device Lot Number: 0000021700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/28/2019; 09/12/2019; 03/05/2020
• Supplement Dates FDA Received: 09/04/2019; 09/18/2019; 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR