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

Model Number 100152HS-V-A1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer for evaluation.The investigation is currently underway.

Event Description

It was reported that during positioning of an embolization coil in a left paraclinoid internal carotid artery aneurysm, the coil stretched.During removal of the coil, a lot of resistance was encountered and the coil detached in the catheter.The vessel was reported to be tortuous.Both segments of the coil and the microcatheter were removed together from the patient without further incident.There was no reported patient injury.The patient's current status is reported to be good.

Manufacturer Narrative

The device was returned without an introducer or dispenser coil.The implant was not returned with the pusher.The pusher is stretched at the body coil distal of attachment bond section.The body coil proximal of attachment bond is secured with the 0.001" stretch resistant wire and not damaged.Based on the provided information, the body coil was confirmed to be stretched distal to the attachment bond and the implant coil had detached, per the reported complaint.The stretching is evidence that the coil was subjected to forces that exceeded its strength specifications.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• 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 ; 7142478000
• MDR Report Key: 6375325
• MDR Text Key: 68966639
• Report Number: 2032493-2017-00048
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636027838
• UDI-Public: (01)00812636027838(11)160519(17)210519(10)160519V8
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K132952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/19/2021
• Device Model Number: 100152HS-V-A1
• Device Lot Number: 160519V8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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 Age: 62 YR
• Patient Weight: 60