MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-450610
Medical Device Problem Codes	Stretched (1601); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/09/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature.It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.Per the instructions for use: potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Based on the investigation, the complaint is confirmed as the implant is stretched.The coil and delivery pusher are intact.The device has evidence of a force being applied.The microcatheter could not be evaluated as it was not returned for evaluation.Mvi ref.(b)(4).
Event or Problem Description
It was reported that during treatment of an aneurysm, upon coil positioning and packing, the coil was reported to stretch.It was reported that the patient died due to trauma.It was stated that it was not device related.Additional information received on march 16, 2016: the stretched coil and delivery pusher were removed together with the microcatheter without incident.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5556130
• Report Number: 2032493-2016-00063
• Device Sequence Number: 520348
• Product Code: KRD
• UDI-Device Identifier: 00810170014918
• UDI-Public: (01)00810170014918(11)150918(17)200918(10)150918MC1
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/18/2020
• Device Model Number: 45-450610
• Device Lot Number: 150918MC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/07/2016
• 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
• Patient Age: 47 YR