MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X10MM)

Model Number	BC0410C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Thrombus (2101); Rupture (2208)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances 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 device was not returned to the manufacturer; therefore, a product evaluation could not be performed.The root cause is unknown.The instructions for use (ifu) identify vessel or aneurysm perforation intracerebral/intracranial hemorrhage, pseudoaneurysm, and thrombus formation as potential complications associated with use of the device.
Event or Problem Description
It was reported that the patient was diagnosed with a subarachnoid hemorrhage, hunt and hess grade 2.Ct imaging demonstrated two aneurysms in the anterior communicating artery, fisher scale grade 2.On (b)(6) 2019, balloon assisted coil embolization was attempted as treatment.The scepter balloon was inflated in the acom artery with its distal end in the left a2 segment and the proximal end in the right a1 segment.After placement of the second coil in the larger aneurysm, control angiography demonstrated contrast extravasation near the smaller left-sided aneurysm, which was likely a neck rupture during inflation of the balloon.A follow-up angiogram revealed that the contrast extravasation had subsided, and there appeared to be an area of acute thrombus formation near the neck of the smaller aneurysm, which likely occluded the rupture site.A dilation of the proximal a2 segment of the left acomm artery was also noted, which was likely indicative of a pseudoaneurysm.Coil embolization of the smaller aneurysm resumed, and follow-up angiograms demonstrated the coil mass was well seated within the larger aneurysm, the parent vessel was widely patent, and there was no further evidence of contrast extravasation from the smaller aneurysm.The patient was enrolled in the rage clinical trial.Follow-up information received on 8/19/19 from the clinical site that the patient is deceased and the death is attributed to the study disease and not the device.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X10MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8963145
• Report Number: 2032493-2019-00207
• Device Sequence Number: 3147142
• Product Code: MJN
• UDI-Device Identifier: 00842636020539
• UDI-Public: (01)00842636020539(11)190403(17)220331(10)19040358A
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 03/31/2022
• Device Model Number: BC0410C
• Device Catalogue Number: BC0410C
• Device Lot Number: 19040358A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• 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: Life Threatening
• Patient Age: 63 YR