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

Model Number MV-AX50617CD

Device Problems Detachment Of Device Component (1104); Stretched (1601); Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

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 not been returned for evaluation.

Event Description

It was reported that during a splenic artery embolization, the coil did not properly shape.During removal, the coil unexpectedly stretched and detached.Both segments of the coil were removed together with the microcatheter from the patient.There was no reported intervention, health damage, or patient injury.

Manufacturer Narrative

The device was returned for analysis.There was evidence of stretching along the proximal 15cm of the coil, with minimal damage in the remaining distal portion.There was no evidence of lost shape in the area that is not stretched or damaged.The implant coil portion that was returned was damaged and stretched; however, no fractures or breaks were noted along the length.The monofilament knot-tie was intact at the attachment zone, with evidence of stretching and prolapsing of the wire filar just distal to knot-tie.Based on the investigation, the implant coil was not broken into separate pieces; however, the coil was stretched and damaged.The root cause is unknown; however, the damage to the device exhibited evidence that it was subjected to excessive tensile force that exceeded the maximum strength specification.

• Brand Name: AZUR CX 35 DETACHABLE
• 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: 7204366
• MDR Text Key: 97803228
• Report Number: 2032493-2018-00015
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2022
• Device Model Number: MV-AX50617CD
• Device Lot Number: 170706149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2017
• 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