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

Model Number	100410HC-S-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/12/2016
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 has been returned, however the evaluation is currently in progress.Following completion of the investigation, a follow-up medwatch will be submitted.(b)(4).
Event or Problem Description
It was reported from (b)(6) that during an embolization treatment of an aneurysm, the coil prematurely detached within the microcatheter.The entire system was removed.No intervention was taken.No harm or injury was incurred due to this incident.

• Brand Name: MICROPLEX HELICAL SOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5723626
• Report Number: 2032493-2016-00127
• Device Sequence Number: 18850308
• Product Code: HCG
• UDI-Device Identifier: 00810170010149
• UDI-Public: (01)00810170010149(11)151214(17)201231(10)15121413
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2016

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: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: 100410HC-S-V
• Device Lot Number: 15121413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2016
• Initial Report FDA Received Date: 06/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1