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

Model Number MV-AZ80620HL

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

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 Description

It was reported that the coil was difficult to position approximately one minute after insertion into the microcatheter.During the attempt to withdraw the coil, resistance was encountered and the coil detached in the microcatheter.The coil was removed in its entirety together with the microcatheter.Upon inspection after coil removal, it appeared that the hydrogel "came off." there was no reported patient injury, intervention, or health damage.

Manufacturer Narrative

The pusher and implant were returned for analysis.Review of the returned pusher found only minor damage.The gold connector had a minor bend.Approximately 1" instance of lead wire separation was noted.There was no evidence of thermal detachment on the pusher strain relief.The distal edge of the strain relief was found to be slightly deformed.The pusher was found to contain a small bend in the core wire.The implant was found to be in good condition and without damage.The gel was expanded on the implant.The monofilament was found to be protruding from the proximal end of the implant.The monofilament did not exhibit any clear signs of a root cause.There was a jagged surface and a slight bend in the monofilament.The monofilament was removed from the distal end of the pusher, and found to have rebounded by.24".There was no clear signs of necking noted on the monofilament, but the break point did exhibit a tail.Additionally, there was a jagged surface and a similar bend to that on the monofilament on the implant.Based upon the investigation analysis and available information, the reported complaint was able to be verified.The implant was returned detached from the pusher; however, the microcatheter was not returned, preventing complete analysis of the reported complaint.The root cause cannot be definitively determined at this time.The profile of the monofilament exhibits some characteristics that are consistent with a tensile break, but are not definitive.

• Brand Name: AZUR DETACHABLE HELICAL HYDROCOIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8479288
• MDR Text Key: 140801294
• Report Number: 2032493-2019-00076
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892000553
• UDI-Public: (01)04987892000553(11)170824(17)220731(10)170824523
• Combination Product (y/n): N
• PMA/PMN Number: K091882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: MV-AZ80620HL
• Device Lot Number: 170824523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1