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

Model Number	45-651026
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
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 was not available to send to the manufacturer for analysis; therefore, a product analysis could not be performed.The root cause is unknown.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 coil embolization was attempted in an aneurysm on a patient with a type ii endoleak.An attempt to place the 2nd coil was not successful and during retraction, the coil stretched into a "hair thin wire" and became stuck "where the graft met the sac," so it could not be removed from the catheter.All access and delivery system devices were removed from the patient and a surgical femoral cut down was performed.The wire was then pulled with excessive force and the wire came free.The arteriotomy was closed and the patient did well in recovery.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8197278
• Report Number: 2032493-2018-00289
• Device Sequence Number: 1653115
• Product Code: KRD
• UDI-Device Identifier: 00810170016103
• UDI-Public: (01)00810170016103(11)151026(17)201026(10)151026JC3
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/26/2020
• Device Model Number: 45-651026
• Device Catalogue Number: 45-651026
• Device Lot Number: 151026JC3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/26/2018
• 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
• Patient Age: 41 YR
• Patient Weight: 134