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

Model Number 100153HS3D-V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Rupture (2208)

Event Date 10/06/2014

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The coil was implanted in the patient and the pusher was not returned for evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.

Event Description

It was reported that after placement of the 5th embolization coil in an aneurysm, the coil was noted to extend beyond the confines of the aneurysm wall.After the coil was repositioned, a puff injection revealed a small amount of contrast extravasation.An occlusion balloon was inflated for 5 mins and protamine was administered.Subsequent angiography demonstrated the coil was well seated in the aneurysm and the parent vessel was widely patent.There was no further evidence of extravasation.The event did not lead to any untoward medical occurrence in the patient or result in any negative clinical outcome.

• Brand Name: MICROPLEX HYPERSOFT 3D
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9802993
• MDR Text Key: 187556399
• Report Number: 2032493-2020-00056
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00854111006044
• UDI-Public: (01)00854111006044(11)190819(17)240909(10)19081929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Model Number: 100153HS3D-V
• Device Catalogue Number: FGA25040-030
• Device Lot Number: 140630N7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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