MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11MM)

Model Number	BC0411XC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982); Perforation of Vessels (2135)
Date of Event	04/05/2019
Type of Reportable Event	Death
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 device was not returned to the manufacturer; therefore, a product evaluation could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that during an elective case treatment of an unruptured anterior communicating aneurysm (acom), an embolization coil continued to herniate out of the aneurysm, and the physician chose to use a scepter xc balloon to assist.The coil was removed and a smaller coil was used, and inflated the scepter xc balloon to match the acom size.Several attempts were made to get the deployed coil to stay in the aneurysm.A medtronic rep instructed the physician to inflate the balloon while removing the 45° angled echelon 10 microcatheter.During removal of the echelon 10, the microcatheter perforated the aneurysm.Intracranial bleed ensued, and the physician sacrificed the a1 in an attempt to save the patient.Six (6) coils were to sacrifice the a1, and stopped the bleeding.An external ventricular drain was placed and the patient was followed for a few days; however, was reported to have died over the weekend.The physician did not make any suggestions of device failure for medtronic or microvention devices used for the procedure.
Additional Manufacturer Narrative
Patient code 1982.Additional information received from the sales rep stated that no device is returning, since the rupture was caused by the medtronic echelon 10 microcatheter, and none of our products failed.The cause of death was due to the major stroke the patient suffered from the peri-procedural rupture.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11MM)
• Common Device Name: BALLOON
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8579850
• Report Number: 2032493-2019-00117
• Device Sequence Number: 16528188
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)180807(17)210731(10)180807547
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113698
• 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,Followup
• Report Date (Section B): 04/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: BC0411XC
• Device Catalogue Number: BC0411XC
• Device Lot Number: 180807547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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: Death; Required Intervention
• Patient Age: 65 YR