MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	8410-0358
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	04/04/2016
Type of Reportable Event	Death
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.Based on the information provided and condition of the returned sample, the root cause of this complaint cannot be determined.(b)(4).
Event or Problem Description
The patient presented allegedly unconscious with a ruptured p comm aneurysm.The patient had a ventriculoperitoneal shunt previously implanted to relieve intracranial pressure.The physician treatment plan was to perform an embolization of the aneurysm.During the treatment procedure of the p comm aneurysm, it was reported to the manufacturer that the delivery of an embolization coil into the aneurysm was uneventful, but that the detachment of the embolization coil from its delivery system encountered difficulties.Attempts made to retrieve the embolization coil from the aneurysm apparently caused the embolization coil to stretch at some point during the manipulations.Several medical devices were used in the procedure, including an aspiration catheter, a distal access catheter, a guidewire, and a coronary balloon catheter.During these manipulations, it was determined that the coil had detached from its delivery pusher but that a portion of the coil remained in the catheter.A coronary balloon (mfg.Unknown) was used to assist in retrieval.The catheter, the balloon and portion of the coil were visualized until the system had exited the guide catheter.Images confirmed that most of the embolization coil remained in the aneurysm with a small portion of the coil visible in the vessel.This was addressed by a coil -assisting stenting procedure using an lvis jr.Stent.The stent was uneventfully delivered through a headway 17 catheter.Diagnostic angiograms were performed and no further intervention was deemed necessary by the physician.The immediate post-procedure patient condition was reported as not changed from the time the patient was admitted to hospital.The patient was reported to have passed away on (b)(6) 2016.The cause of death is not known by the manufacturer at this time.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5627500
• Report Number: 2032493-2016-00085
• Device Sequence Number: 10775468
• Product Code: HCG
• UDI-Device Identifier: 00811425028070
• UDI-Public: (01)00811425028070(11)151001(17)201001(10)151001V5
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/01/2020
• Device Model Number: 8410-0358
• Device Lot Number: 151001V5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2016
• Initial Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 59 YR