MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 17 MICROCATHETER

Model Number MC172150SX

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

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 05/25/2017

Event Type  Death  

Manufacturer Narrative

The lot number information was not provided; therefore, the device history record (dhr) could not be reviewed.The device was discarded at the user facility; therefore, a product analysis could not be performed.There was no reported device malfunction.The physician stated that the hemorrhage from the vessel dissection was straightening of the vessel when the microcatheter crossed the target area.The instructions for use (ifu) identifies hemorrhage and death as potential complications associated with use of the device.The device was used during the same procedure as was reported in mfr.Report# 2032493-2017-00151.

Event Description

It was reported that a stent-assisted coiling treatment was performed on an anterior communication artery (a-comm) aneurysm via the right internal carotid artery, on a patient with 4-5 aneurysms in the intracranial vasculature.The microcatheter was placed across the a1 to the contralateral a2, and the stent was advanced through the microcatheter then deployed.The stent looked well apposed.The microcatheter was re-crossed through the deployed stent to attempt an exchange for a smaller microcatheter in order to access one of the cells.A few minutes later, a severe bleed was discovered with roadmap imaging; however, the source of the bleed could not be determined.Protamine was administered to the patient and a temporary coil was placed in the right a1 to stop the bleeding.Once the bleeding stopped, the previous angiograms were reviewed.The images revealed the bleeding was present prior to the stent implantation and the tortuous a2 to the a-comm to the contralateral a2 vessel segment was straightened out by the microcatheter.Surgical intervention was performed to relieve intracranial pressure and evacuate clot.It was the consensus of two physicians that there was a spontaneous/spiral dissection that resulted from the straightening out of the vessel during access by the microcatheter and the stent tracking through it.Four (4) days after the procedure, the patient died.The physician stated the cause of death was hemorrhage from the vessel dissection caused by straightening of the vessel when the microcatheter crossed the target area.There was no reported device malfunction.

• Brand Name: HEADWAY 17 MICROCATHETER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780
• MDR Report Key: 6665744
• MDR Text Key: 78343906
• Report Number: 2032493-2017-00152
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

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: Other
• Device Model Number: MC172150SX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death