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

Model Number	100206HS-V-A2
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Occlusion (1984)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 coil remains implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that several attempts were made to detach an embolization coil; however, the coil did not detach.During removal, the coil unexpectedly detached, leaving some of the implanted coil in the parent artery.The physician chose to occlude the carotid artery, which resulted in occlusion of the anterior communicating artery and two (2) a2 arteries.Reopro and heparin were administered.A subarachnoid hemorrhage occurred during the night, and an external ventricular drain (evd) was performed.The patient is reported to have no neurological deficit.

• Brand Name: MICROPLEX HYPERSOFT HELICAL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7016469
• Report Number: 2032493-2017-00275
• Device Sequence Number: 156304
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)170523(17)220430(10)17052353L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2022
• Device Model Number: 100206HS-V-A2
• Device Lot Number: 17052353L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/09/2017
• 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