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

Model Number	100206HS-V
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional 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 coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment was performed on an anterior communication artery aneurysm five (5) days after the patient had a subarachnoid hemorrhage and vasospasm.During placement of the fourth coil, the coil stretched and then detached in the microcatheter without use of the controller.There was no additional intervention and the coil was left in position in the aneurysm.A total of 16 coils were placed in the aneurysm.Two (2) days after the procedure, the patient was treated for vasospasm with a combination of pharmacological and angioplasty, and has had three (3) subsequent vasospasm treatments since.There was no reported patient injury as a result of the coil detachment.The patient is reported to be "not in great condition following the sah and delayed treatment.".

• 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: 8097886
• Report Number: 2032493-2018-00247
• Device Sequence Number: 14139463
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)180424(17)230331(10)1804241W2
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 100206HS-V
• Device Lot Number: 1804241W2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR