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

Model Number 7310-0408

Device Problems Difficult To Position (1467); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment, not diagnosis.The hydrocoil embolic system (hes) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.The hes 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.The evaluation of the returned device could not be confirmed as the implant coil was not available for evaluation.However, it is possible the pusher became stretched during retraction.The heater coil section of the delivery pusher exhibited evidence of thermal detachment via the detachment controller.(b)(4).

Event Description

The customer reported that during the embolization treatment of a vertebral artery vessel takedown, the coil stretched during positioning.The coil length appeared short.The stretched coil could not be observed under fluoroscopy and was not identified within the microcatheter.The physician indicated she was not explore further if the coil was in the vessel as it was a takedown and would be irrelevant.The same catheter was used to deploy additional coils without incident.On (b)(6) 2015 the patient was reported to be fine.

• Brand Name: HYDROFILL ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: bill wiggins ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 5148677
• MDR Text Key: 28581270
• Report Number: 2032493-2015-00166
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: 7310-0408
• Device Lot Number: 141227V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1