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

Model Number	100153HS3D-V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Rupture (2208)
Date of Event	10/06/2014
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9802993
• Report Number: 2032493-2020-00056
• Device Sequence Number: 779054
• Product Code: HCG
• UDI-Device Identifier: 00854111006044
• UDI-Public: (01)00854111006044(11)190819(17)240909(10)19081929
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention