MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL; EMBOLIZATION COIL

Model Number UNKNOWN

Device Problem Difficult To Position (1467)

Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Thrombus (2101)

Event Date 03/27/2017

Event Type  Death  

Manufacturer Narrative

The lot number was not provided; therefore, the device history records could not be reviewed.The coil remains implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.No autopsy was performed, and the physician was unable to provide a reason for the subarachnoid hemorrhage.The root cause cannot be determined.

Event Description

It was reported that three (3) coils were implanted in an aneurysm at the right sylvian bifurcation.During the placement of the fourth coil, one of the previously implanted coils "moved partially" into the parent artery (m2 segment), which resulted in a thrombus.A balloon inflation was performed in the m2, followed by a stent implantation.Reopro was administered.Subsequent post-procedure angiography demonstrated a subarachnoid hemorrhage (sah).The patient was placed under complete anesthesia and brought to the icu.The patient died approximately 24 hours later.The physician was unable to provide a reason for the sah hemorrhage.An autopsy was not performed.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6524661
• MDR Text Key: 73780076
• Report Number: 2032493-2017-00103
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• 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
• Patient Age: 65 YR
• Patient Weight: 85