MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; 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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

This is first of 2 reports.The subject device is unavailable to manufacturer.

Event Description

Prior procedure, the patient presented with ischemic syndrome in the left-sided with national institute of health stroke scale (nihss) score of 8 and modified ranquin scale (mrs) of 4.It was reported that during mechanical thrombectomy procedure using the subject retrieval device along with other device (distal access catheter device) to remove a clot from the left m2 middle cerebral artery (mca).The technique used for this pass was considered successful.In the angiogram immediately after thrombectomy, new ent (embolization to the new territory) occurred in the middle cerebral artery (mca)- m3 branch of the superior trunk.Ent was not treated due to embolized branch was too small for thrombectomy and the cause of ent is unknown.It was suspected that there was fragmentation of the thrombus during the thrombectomy maneuver but it is not clear if the residual symptoms were caused by an infarction in the initially occluded vessel or by an infarction in the brain tissue behind the branch which was occluded due to the embolization to the new territory.The procedure was completed with thrombolysis in cerebral infarction score (tici) of 2b67.The patient is currently fine without any significant disability with modified ranquin scale (mrs) of 1.

Event Description

Prior procedure, the patient presented with ischemic syndrome in the left-sided with national institute of health stroke scale (nihss) score of 8 and modified ranquin scale (mrs) of 4.It was reported that during mechanical thrombectomy procedure using the subject retrieval device along with other device (distal access catheter device) to remove a clot from the left m2 middle cerebral artery (mca).The technique used for this pass was considered successful.In the angiogram immediately after thrombectomy, new ent (embolization to the new territory) occurred in the middle cerebral artery (mca)- m3 branch of the superior trunk.Ent was not treated due to embolized branch was too small for thrombectomy and the cause of ent is unknown.It was suspected that there was fragmentation of the thrombus during the thrombectomy maneuver but it is not clear if the residual symptoms were caused by an infarction in the initially occluded vessel or by an infarction in the brain tissue behind the branch which was occluded due to the embolization to the new territory.The procedure was completed with thrombolysis in cerebral infarction score (tici) of 2b67.The patient is currently fine without any significant disability with modified ranquin scale (mrs) of 1.

Manufacturer Narrative

The device history record review confirms that there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation and was prepared as per the dfu, continuous flush was maintained, and there was mild tortuosity in the patient's anatomy.The cause of the ent and its relation to the subject device could not be definitively determined.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, an assignable cause of anticipated procedural complication will be assigned to this event.

Event Description

Prior procedure, the patient presented with ischemic syndrome in the left-sided with national institute of health stroke scale (nihss) score of 8 and modified ranquin scale (mrs) of 4.It was reported that during mechanical thrombectomy procedure using the subject retrieval device along with other device (distal access catheter device) to remove a clot from the left m2 middle cerebral artery (mca).The technique used for this pass was considered successful.In the angiogram immediately after thrombectomy, new ent (embolization to the new territory) occurred in the middle cerebral artery (mca)- m3 branch of the superior trunk.Ent was not treated due to embolized branch was too small for thrombectomy and the cause of ent is unknown.It was suspected that there was fragmentation of the thrombus during the thrombectomy maneuver but it is not clear if the residual symptoms were caused by an infarction in the initially occluded vessel or by an infarction in the brain tissue behind the branch which was occluded due to the embolization to the new territory.The procedure was completed with thrombolysis in cerebral infarction score (tici) of 2b67.The patient is currently fine without any significant disability with modified ranquin scale (mrs) of 1.Update information: additional information received on 6-january-2021 from the medical safety indicated that that there was embolization of the mca-m3, branch of the superior trunk from the target vessel left mca-m2.This event is defined as a distal embolization (de), a downstream occlusion distal to the conventional angiography target occlusion (cato), into the target ischemic territory.De is not a new territory embolization.De is remnant of the original clot in the affected territory.De is not a reportable event as there is no additional harm to the patient.The embolization was not treated, there was no adverse event reported and no device malfunction.Therefore, this event does not meet reporting criteria anymore.

Manufacturer Narrative

Section b1 adverse event: corrected: no adverse event.Section b2: outcomes attributed to ae: corrected: no other serious (important medical events).Section h1: type of reportable event: corrected: removed serious injury - no serious injury.Based on additional information received on 6-january-2021 from medical safety, it was clarified that there was embolization of the mca-m3 branch of the superior trunk from the target vessel left mca-m2.This event is defined as a distal embolization (de), a downstream occlusion distal to the conventional angiography target occlusion (cato), into the target ischemic territory.De is not a new territory embolization.De is remnant of the original clot in the affected territory.De is not a reportable event as there is no additional harm to the patient.The embolization was not treated, there was no adverse event reported and no device malfunction.Therefore, ¿device within specifications' has been assigned to this complaint with an assignable cause of undeterminable.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.This is 1 of 2 reports.

• Brand Name: TREVO XP PROVUE 4MM 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
• MDR Report Key: 10274066
• MDR Text Key: 199074359
• Report Number: 3012931345-2020-00100
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2021
• Device Catalogue Number: 90182
• Device Lot Number: 0000026495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST 6 (STRYKER)
• Patient Outcome(s): Other