MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COMPLEX; EMOLIZATION COIL

Model Number	100512CC-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The microplex coil system (mcs) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.The mcs is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.Per the instructions for use: 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, post-embolization syndrome, and neurological deficits including stroke and possibly death.Cases of chemical aseptic meningitis, edema, hydrocephalus and/or headaches have been associated with the use of embolization coils in the treatment of large and giant aneurysms.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.This device involved in this event could not be evaluated as it was reported not available.The root cause cannot be determined or confirmed.(b)(4).
Event or Problem Description
The customer reported that during an embolization coiling treatment, resistance was encountered during coil positioning.The coil was reported to prematurely detached from the delivery pusher within the catheter.The coil and catheter were withdrawn together successfully.No harm or injury occured as a result of this incident.

• Brand Name: MICROPLEX COMPLEX
• Common Device Name: EMOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia ave; tustin CA 92780
• MDR Report Key: 5490698
• Report Number: 2032493-2016-00036
• Device Sequence Number: 13712575
• Product Code: HCG
• UDI-Device Identifier: 00811425025659
• UDI-Public: (01)00811425025659(11)151105(17)201105(10)151105V2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/05/2020
• Device Model Number: 100512CC-V-A
• Device Lot Number: 151105V2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2016
• Initial Report FDA Received Date: 03/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR