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

Model Number	45-682050
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	02/14/2019
Type of Reportable Event	Malfunction
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 has not been returned 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 during an embolization treatment for a fistula off the left main branch to the coronary sinus, the coil was advanced to the distal part of the fistula.The distal portion of the coil advanced beyond a previously implanted amplatzer vascular plug (avp); therefore, the coil was pulled back to reposition it.Tension on the pusher wire was encountered, and the coil detached inside the catheter.The coil was removed in its entirety along with the catheter.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
Additional information (device return).Both the implant and pusher were returned.The introducer sheath and microcatheter used were not returned.The pusher was inspected and observed to be in good condition.The proximal solder joint was observed to be undamaged and intact.The body coils of the pusher were undamaged and the attachment bond zone was in good condition.The strain relief was slightly folded.The implant was found to have stretched coils at the proximal end.The monofilament was removed from inside the pusher and it displayed a stretched tail profile.Based upon the investigation analysis and available information, the reported complaint is confirmed.The stretched tail profile of the monofilament indicates that the implant detached from the pusher as a result of a tensile force over specification being placed on the device.

• 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: 8426936
• Report Number: 2032493-2019-00055
• Device Sequence Number: 14010077
• Product Code: HCG
• UDI-Device Identifier: 00810170017834
• UDI-Public: (01)00810170017834(11)180630(17)230531(10)18063051Y
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 45-682050
• Device Catalogue Number: 45-682050
• Device Lot Number: 18063051Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1