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

Model Number	45-482030
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not bee returned to the manufacturer.The lot number was provided and the device history records are being reviewed.The investigation is currently underway.
Event or Problem Description
It was reported that while treating an angiomyolipoma in the kidney.The md used a progreat 2.8 with a framing coil 14x35, he then requested the biggest hydrocoil available 20x30.The progreat had a hair pin turn almost folding on itself.The anatomy was very tortuous and the hydrocoil unexpectedly detached in the catheter.The progreat and coil were removed and a smaller hydrocoil was deployed with no issues.No injury was reported.The patient's condition is said to be "fine".The procedure outcome was successful, the microcatheter was removed and the coil was replaced.
Additional Manufacturer Narrative
The device was returned for analysis without the pusher.The implant coil was noted to be stretched at the proximal end, with extended length of approximately 5cm.There was evidence of tensile failure of the monofilament proximal to the implant marker band.Based on the investigation and provided information, the complaint cannot be confirmed.The implant coil was noted to be stretched, not broken, and the pusher was not returned for evaluation.The specific root cause of this complaint is unknown; however, implant coil stretching indicates the device was subjected to forces that exceeded its design specifications.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6355657
• Report Number: 2032493-2017-00043
• Device Sequence Number: 13559178
• Product Code: KRD
• UDI-Device Identifier: 00810170017841
• UDI-Public: (01)00810170017841(11)151021(17)201021(10)151021LC3
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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: Physician
• Device Expiration Date: 10/21/2020
• Device Model Number: 45-482030
• Device Catalogue Number: 45-480202
• Device Lot Number: 151021LC3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 10/23/2017
• 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