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

Model Number	8510-0308
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/19/2016
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 not yet been returned for evaluation.Upon examination of the sample/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 catheter during positioning.No patient harm or injury was reported.
Additional Manufacturer Narrative
Based on the investigation findings the complaint cannot be confirmed as the pusher was not available for evaluation.However, it is likely the device was exposed to a force that exceeded the maximum tensile specification as the implant is stretched damaged.Reference mvi: (b)(4).Missing information from this report is identified as a blank, unknown and as no information (ni); this information was not provided in the reported event or available at the time of report submission.

• Brand Name: HYPERSOFT ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5661529
• Report Number: 2032493-2016-00096
• Device Sequence Number: 10765338
• Product Code: HCG
• UDI-Device Identifier: 00811425027844
• UDI-Public: (01)00811425027844(11)151125(17)201125(10)151125V2
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2016

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: 11/25/2020
• Device Model Number: 8510-0308
• Device Lot Number: 151125V2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 06/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR