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

Model Number 100358HS3D-V-A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

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 device has not yet been returned for evaluation.The investigation is currently ongoing.

Event Description

It was reported that during repositioning of the embolization coil for treatment of a right internal carotid artery aneurysm, the coil stretched and unexpectedly detached in the microcatheter, leaving a section of the detached coil outside of the treatment area.The pusher wire was used to push the detached coil segment into the aneurysm.There was no reported patient injury.The current patient's status is reported to be doing well.

Manufacturer Narrative

The proximal segment of implant was returned for analysis; however, the distal portion of the implant coil was not returned.The implant was noted to be detached and completely stretched throughout its body.The pusher was noted to be bent proximal to the black pet transition area.The body coil section had a few kinks.The hypotube was found kinked distal to the gold plated section.The monofilament had striation marks on its body at the distal end, confirming a tensile pull.Based on the available information and evaluation of the implant, the reported complaint can be confirmed.The proximal segment was stretched and detached from the pusher.The specific root cause of this complaint is unknown, although the findings are consistent to cases where the device was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: MICROPLEX HYPERSOFT 3D
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 6819641
• MDR Text Key: 83630184
• Report Number: 2032493-2017-00204
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425025574
• UDI-Public: (01)00811425025574(11)161003(17)210930(10)161003V5
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161452
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 100358HS3D-V-A
• Device Lot Number: 161003V5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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