MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT 3D; EMBOLIZATION COIL

Model Number 100408HS3D-V-N

Device Problems Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 03/12/2015

Event Type  malfunction  

Event Description

The initial reported complaint for this device was rec'd on (b)(6) 2015 for the introducer tube stuck within the device dispenser coil prior to use.On 06/09/2015 a correction/revised complaint was rec'd indicating the following; coiling treatment was conducted of a aneurysm.It was reported that as the coil did not take the desired shape in the aneurysm.Upon withdrawal, resistance was encountered and the coil prematurely detached within the microcatheter.The catheter and coil were removed together successfully.No injury was reported with the patient as a result of the procedure.

Manufacturer Narrative

The delivery pusher and coil were returned for eval and confirmed the implant coil was stretched and detached.The eval shows excessive force was used which likely led to the coil becoming detached.(b)(4).

• Brand Name: MICROPLEX HYPERSOFT 3D
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA
• Manufacturer Contact: teri halverson ; 1311 valencia; tustin, CA 92780 ; 7142478000
• MDR Report Key: 4886659
• MDR Text Key: 6059882
• Report Number: 2032493-2015-00102
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Model Number: 100408HS3D-V-N
• Device Lot Number: 140501N7
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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 Age: 52 YR
• Patient Weight: 82