MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX DETACHABLE; EMBOLIZATION COIL

Model Number	45-780516
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	08/24/2018
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.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, vascular thrombosis, unintended parent artery occlusion, and coil misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that during repositioning of an embolization coil in a ruptured aneurysm, resistance was encountered and then the coil detached in the vessel.Hemostasis was successfully achieved; however, the coil was positioned suboptimally, a little lower than expected, which occluded a relatively large splenic vessel.As a result, the patient received appropriate vaccines due to the possible risk of splenic infarction and potential for asplenia.There was no clinical consequence to the patient, and the patient is currently reported to be feeling well.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7900189
• Report Number: 2032493-2018-00193
• Device Sequence Number: 16591210
• Product Code: KRD
• UDI-Device Identifier: 00810170018305
• UDI-Public: (01)00810170018305(11)170718(17)220630(10)17071854V
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 06/30/2022
• Device Model Number: 45-780516
• Device Catalogue Number: 45-780516
• Device Lot Number: 17071854V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/21/2018
• 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: Disability
• Patient Age: 38 YR
• Patient Weight: 59