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

Model Number 100256HS-V-A

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

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

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned to the manufacturer.The lot number was provided and the device history records are being reviewed.The investigation is currently underway.

Event Description

It was reported that during placement of an embolization coil in an aneurysm, resistance was encountered and the coil would not advance any further.The coil then detached from the pusher wire at the transition zone in the microcatheter.The detached coil was removed from the patient with a snare device without incident.There was no reported patient injury.The patient's current condition is reported to be "not bad.".

Manufacturer Narrative

The device was returned with no dispenser coil or introducer.The pusher coil was noted to be completely broken from the transition zone.The separated hypotube, along with the remainder proximal section, was not returned for evaluation.On the distal side, part of the implant coil was noted to be stretched out from the proximal tie knot location, and completely broken.The remaining implant coil along with the marker band was still attached to the pusher, with good tension in the monofilament.The distal black pet covering the heater coil had no signs of thermal damage.The returned product evaluation confirmed a broken coil.The reported event details indicated that the coil became detached during repositioning.It is possible that the device was subjected to forces that exceeded its tensile strength specifications; however, the exact root cause cannot be determined.The device was used during the same procedure as was reported in mfr report# 2032493-2017-00050.

• 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: 6239763
• MDR Text Key: 64423088
• Report Number: 2032493-2017-00008
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

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: 12/31/2019
• Device Model Number: 100256HS-V-A
• Device Lot Number: 141231V2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: 11/24/2016
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 55