MAUDE Adverse Event Report: TREVO PRO 18 MICROCATHETER 157CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90238

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that during the study procedure with the subject device (microcatheter), the asymptomatic intracranial hemorrhage was occurred which resulting in life-threatening illness and hospitalization.However, the outcome of the adverse event was resolved.It¿s indicated that there was relationship between the adverse event to the index stroke, the index procedure and the subject device (microcatheter).No other information was provided.

Manufacturer Narrative

Section b5 executive summary - updated section d: catalog # search,product long description,and lot # - updated section d4: expiration date - added section h4: manufacturing date - added the device history record review confirms 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 post unpacking and preparation, the device was prepared as per the dfu, and the physician did not have any allegation against the subject device.The reported 'patient intracranial hemorrhage' 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

It was reported that during the study procedure with the subject device (microcatheter), the asymptomatic intracranial hemorrhage was occurred which resulting in life-threatening illness and hospitalization.However, the outcome of the adverse event was resolved.It¿s indicated that there was relationship between the adverse event to the index stroke, the index procedure and the subject device (microcatheter).No other information was provided.Update information: based on the physician¿s opinion the anatomy was a bit tortuous and the placement of the catheter in the bifurcation was the cause of intracranial hemorrhage.The anatomy location of the reported intracranial hemorrhage were subarachnoid hemorrhage + basal ganglia.

• Brand Name: TREVO PRO 18 MICROCATHETER 157CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10336219
• MDR Text Key: 200829449
• Report Number: 3012931345-2020-00110
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K113260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: 90238
• Device Lot Number: 39028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Other