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

Model Number 100206HS-V[ER]

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem Infarction, Cerebral (1771)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there are no similar complaints reported for this lot number.The delivery pusher with the most proximal end of the implant coil attached was returned for evaluation.The distal segment of the implant coil was not returned.The implant coil is broken at the attachment glue section.The total length of the broken piece of the implant coil is 3.5cm.Approximately 2cm of implant coil is missing from the device.The broken end of the implant coil appears to be kinked.Based on the information provided and the evaluation results, the device was likely subjected to excessive force during positioning attempts and retraction, which overcame the tensile strength of the coil, causing it to detach.

Event Description

It was reported that coil embolization treatment was being performed on an unruptured mca aneurysm.During placement of the last coil, resistance was encountered.An attempt was made to withdraw the coil out together with the microcatheter; however, the coil detached with part of the coil in the aneurysm and approximately 2cm of the detached coil in the vessel.The coil fragment was completely retrieved with a microsnare.Post-procedure angiographic images were unremarkable and demonstrated a well-packed aneurysm.The patient was prescribed clopidogrel and aspirin post-operatively.Seven days after the procedure, the patient reported having difficulties with his right arm, minimal visual disturbances, and slight problems with writing.Ct angiography showed a 2cm infarct in the temporo-occipital region and a tripled loop of thin stretched out coil in the mca and down into the ica.The patient was reported to have completely recovered after a couple of weeks.

• Brand Name: MICROPLEX HYPERSOFT HELICAL HYPERSOFT
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: sandra valencia ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6265714
• MDR Text Key: 65345636
• Report Number: 2032493-2017-00030
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 100206HS-V[ER]
• Device Lot Number: 131202H8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• 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
• Patient Outcome(s): Required Intervention