MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COMPLEX DIAMETER; EMBOLIZATION COIL

Model Number 100512CC-V

Device Problems Detachment Of Device Component (1104); Stretched (1601); Device-Device Incompatibility (2919)

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

Event Date 04/20/2017

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 were no similar complaints for this lot number.The pusher was returned to the manufacturer.The implant was detached and not returned, as it was reported to have been implanted in the patient.The distal section of the pusher appears to be within device specifications.The heater coil shows signs of compression, but no signs of thermal damage to the exterior of the device was observed.The monofilament rebounded within the id of the body coil approximately.170" from the proximal end of the heater coil.Based on the available information and evaluation of the returned device segment, the coil break can be confirmed; however, the root cause cannot be determined.

Event Description

It was reported that during repositioning of an embolization coil in an aneurysm, the proximal part of the coil stretched.During removal, the proximal part of the coil stuck in the distal portion of the guiding catheter, and then detached.A stent was implanted to pin the coil to the vessel wall.There was no reported patient injury.The patient's current status is reported to be fine.

• Brand Name: MICROPLEX COMPLEX DIAMETER
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780
• MDR Report Key: 6688421
• MDR Text Key: 79121302
• Report Number: 2032493-2017-00159
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021914
• 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: 06/05/2017

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
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: 100512CC-V
• Device Catalogue Number: 100512CC-V
• Device Lot Number: 1C092425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2013
• 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
• Patient Age: 62 YR