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

Model Number	45-780413
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/07/2019
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 device has been returned to the manufacturer.The investigation is underway.
Event or Problem Description
It was reported that coil embolization was attempted on the gastroduodenal artery (gda) to prepare for y90 treatment using the left hepatic artery.While advancing the coil through the catheter, the catheter popped out of the gda and into the right hepatic artery.The coil was removed prior to an attempt to reposition the catheter, and the catheter was flushed under fluoroscopy, at which time the implant coil could be seen exiting out of the catheter into the proper right hepatic artery.During an attempt to remove the coil with a gooseneck snare, the coil moved further downstream and occluded a branch of the right hepatic artery.Several more attempts were made to retrieve the coil; however, they were unsuccessful and the procedure was finished.The physician commented that the occluded vessel will not have an immediate impact on the patient's treatment plan, as the most significant disease is in the left lobe.The patient has metastatic disease throughout the liver, however, and the area of the liver which was fed by the artery in which the coil settled has a significant tumor.The tumor will find blood supply from other collateral branches and those will revascularize the area.The physician believes that the vessel that is shut down will likely prevent him from treating the affected area as he would have, but he should be able to treat the area with a different, perhaps less preferable, method.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher was returned for analysis.The proximal portion of the pusher was kinked between e2 and e3.The body coils of the pusher were observed to be in good condition.The heater coil contained some blood contamination, and the strain relief was in good condition and unburnt.The monofilament was intact at the attachment glue bond location.The introducer was found to be undamaged.The monofilament was removed from the pusher, and was found to have a rebound of.0250" with a stretched tail profile.Based upon the investigation analysis and available information, the reported complaint was able to be confirmed.The stretched tail profile of the monofilament is the result of a tensile detachment of the implant, and the stretched tail profile is indicative of over specification tensile forces being placed on the device.

• 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: 8479293
• Report Number: 2032493-2019-00074
• Device Sequence Number: 941972
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)180920(17)230831(10)1809205Z8
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 45-780413
• Device Catalogue Number: 45-780413
• Device Lot Number: 1809205Z8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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: Required Intervention; Disability
• Patient Age: 40 YR
• Patient Weight: 106