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

Model Number 100152HS-V-A2

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

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 been returned to the manufacturer.The investigation is currently underway.

Event Description

It was reported that three (3) coils were successfully implanted during a balloon assisted coiling of an anterior communicating artery aneurysm.During the deployment of the fourth coil, the previously implanted coils began to prolapse.The physician pulled the coil back; however, resistance in the microcatheter was encountered.During removal, the coil detached in the microcatheter.Both segments of the coil were removed together with the microcatheter, and the physician aborted the procedure.There was no reported intervention or patient injury.The patient is reported to be good post procedure.

Manufacturer Narrative

The device was returned with the pusher and introducer.The entire pusher appeared wavy and kinked.The introducer tip was noted to be damaged.The hypotube was noted to be kinked.The implant coil was still attached to the pusher with sufficient tension.The strain relief (distal pet) at the heater coil section appeared damaged.The implant coil was separated at the tie knot section.The attachment section appeared in a good condition, with the tie knot still intact and glue cured.Based on the investigation, the complaint was unconfirmed as the implant coil was separated from the pusher at the tie knot; however, it was not detached as reported by the customer.The root cause for the complaint cannot be determined; however, the damage is consistent with the coil being subjected to excessive forces that exceeded its strength specification.

• Brand Name: MICROPLEX HYPERSOFT HELICAL VTA
• 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: 7285716
• MDR Text Key: 100670996
• Report Number: 2032493-2018-00032
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777020543
• UDI-Public: (01)00816777020543(11)170729(17)220630(10)1707291W2
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 100152HS-V-A2
• Device Lot Number: 1707291W2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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
• Patient Age: 48 YR
• Patient Weight: 75