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

Model Number	45-750609
Medical Device Problem Codes	Detachment Of Device Component (1104); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device was has not yet been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that an embolization coil unexpectedly detached during y-90 mapping.It was stated that 50% of the coil went in the gastroduodenal artery (gda) and 50% of the coil in the common hepatic artery, and it unraveled to the femoral artery.The coil was retrieved with a snare device.There was no reported patient injury.
Additional Manufacturer Narrative
The device was returned for evaluation.Evidence of damage and stretching was noted during inspection.The distal 1cm is coiled in primary wind configuration; proximal to that point is 60cm of elongated wire leading to a fracture point.The pusher showed no evidence of kinks or bends on the shaft; however, the measured resistance was noted to be out of specification.There is no evidence of the proximal weld ball.Evidence of damage with the compressed heater coil section and folded strain relief was noted on the distal end of the pusher.The outer sleeve of the pusher was removed to inspect the monofilament and knot-tie.The proximal knot-tie was found to be intact on the pusher; however, the distal end of the monofilament was noted to have evidence of a tensile fracture located approximately 4mm from the distal end of the pusher.Based on the investigation and provided information, the complaint of a coil implant detachment can be confirmed.The root cause is unknown, although the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6648947
• Report Number: 2032493-2017-00144
• Device Sequence Number: 815777
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)160425(17)210425(10)16042511
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 04/25/2021
• Device Model Number: 45-750609
• Device Lot Number: 16042511
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 09/12/2017
• 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
• Patient Age: 80 YR