MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-451520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not yet been returned to the manufacturer.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during re-positioning of the last coil, slight tension was encountered, and the coil detached in the artery.The coil was left implanted in the patient.There was no reported patient injury or intervention.The patient is reported to be doing well.
Additional Manufacturer Narrative
The pusher was returned for analysis; the implant was not attached to the pusher.The proximal end of the pusher was found to be in good condition and without damage.The pusher resistance was found to be within specification at 41.2 ohms.The distal end of the pusher sheath was found to be separated from the adhesive joint.The pusher was also found to contain a slight bend just distal of the adhesive joint.The distal end of the strain relief was found to be smashed and misshapen.The monofilament was removed from the distal end of the pusher for analysis.The monofilament was found to have a rebound of.0140".The distal end of the monofilament was found to have a tail of 0.0030".The profile of the monofilament was identified as stretched based on the investigation findings and available information, the reported complaint is confirmed.The root cause of the reported detachment is due to tension on the implant during retraction.The profile of the distal tip of the monofilament is consistent with a unit that was under excessive tension.The root cause of the tension during retraction cannot be definitely stated based on the information provided.It is suspected that the coil was either stuck on the adjoining coil in the aneurysm, or was caught on the distal end of the microcatheter.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8234013
• Report Number: 2032493-2019-00005
• Device Sequence Number: 1148188
• Product Code: KRD
• UDI-Device Identifier: 00810170015014
• UDI-Public: (01)00810170015014(11)180510(17)230430(10)18051052T
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093002
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 45-451520
• Device Catalogue Number: 45-451520
• Device Lot Number: 18051052T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1