MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number 45-480420-L

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

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 for evaluation.The investigation is currently underway.

Event Description

It was reported that after unsuccessful attempts were made to place the coil during a renal embolization procedure, the coil was retracted; however, resistance was encountered and the coil detached in the microcatheter.Both segments of the coil were removed along with the microcatheter from the patient.There was no reported intervention or patient injury.The patient is reported to be stable.

Manufacturer Narrative

The coil implant was returned for analysis; the pusher was not returned.The implant portion was noted to be in a helical shape, and had minimal evidence of hydrogel expansion.The proximal 1cm segment was noted to have a stretched overcoil and a stretched primary wind.The proximal monofilament knot tie was noted to be intact on the implant.Dissection of the proximal end of the implant indicated a tensile failure of the monofilament.Based on the investigation, the complaint could not be confirmed, as the monofilament showed evidence of tensile break and not a premature detachment.The investigation was limited by the pusher that was not returned, which made it impossible to assess the monofilament end to verify the failure mode.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7311387
• MDR Text Key: 101494282
• Report Number: 2032493-2018-00045
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)170314(17)220228(10)170314LC1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 45-480420-L
• Device Catalogue Number: 45-480420
• Device Lot Number: 170314LC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1