MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS; EMBOLIZATION COIL

Model Number	181243CS-V-A
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Paresis (1998); Thrombus (2101)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
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.No device will be returned to the manufacturer for evaluation, as the coil remains implanted and the pusher wire was discarded at the user facility.Additional information has been requested from the customer.The investigation is currently ongoing.
Event or Problem Description
It was reported that treatment was performed on a large, acute 15mm a-com aneurysm.A double microcatheter technique was employed using two echelon-10s (not mv), and a balloon was placed to assist prior to coil placement.The embolization coil was one of four coils used as framing coils, and it was positioned tightly within the coil mass.The attempt to detach the embolization coil was unsuccessful.The coil had been pre-tested with the controller prior to the procedure and passed.Additional attempts were made to detach the coil using an alternate v-grip controller, without success.Eventually, the coil detached; however, it stretched.Iv aspirin was administered and the stretched portion of the coil was jailed by an acclino stent.Four additional axiom coils (not mv) were then implanted.Formation of thrombus was detected within the stent and reopro was administered.Thrombus aspiration was performed through a sofia catheter, with some success; however, a ct scan was performed post-procedure, which revealed an infarction.A craniotomy was performed to relieve pressure.The patient cannot move her left side.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6216729
• Report Number: 2032493-2016-00308
• Device Sequence Number: 323293
• Product Code: HCG
• UDI-Device Identifier: 00811425025970
• UDI-Public: (01)00811425025970(11)160427(17)210427(10)160427V7
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2016

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: Other
• Device Expiration Date: 04/27/2021
• Device Model Number: 181243CS-V-A
• Device Lot Number: 160427V7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/30/2016
• 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; Disability