MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX VFC ADVANCED; EMBOLIZATION COIL

Model Number VFC101530-V-A2

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problems Infarction, Cerebral (1771); Death (1802); Embolus (1830)

Event Date 11/21/2017

Event Type  Death  

Manufacturer Narrative

The lot number was provided.A review of the device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints reported for this lot number.The device will not be returned for evaluation; therefore, a product analysis will not be performed.The root cause cannot be determined.The instructions for use (ifu) states that, "potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, postembolization syndrome, and neurological deficits including stroke and possibly death.".

Event Description

It was reported that balloon-assisted coil embolization treatment was performed on an acute ruptured right pcom aneurysm.During placement of the 7th coil, the catheter was pushed out by the coil.During an attempt to reposition the coil, it unexpectedly detached while it was partially in the aneurysm and partially in the m1 segment of the middle cerebral artery (mca).The delivery catheter was removed and a microsnare was used to remove the coil through a sofia catheter; however, an embolus occurred in the m1, which resulted in an mca infarct in the right hemisphere, covering approximately 30% of the mca territory.The patient is not on anti-platelet therapy.The patient was reported to be in serious condition.

Manufacturer Narrative

Additional information was received from the (b)(6) on november 21, 2017 that indicated the patient died.No other information was provided.The date and cause of the patient's death is unknown.

• Brand Name: MICROPLEX VFC ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7018148
• MDR Text Key: 91769837
• Report Number: 2032493-2017-00284
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022691
• UDI-Public: (01)00816777022691(11)170418(17)220331(10)170418WC6
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K132317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: VFC101530-V-A2
• Device Lot Number: 17011449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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; Required Intervention