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

Model Number	45-480815
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
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 coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.Case images were provided.The investigation is currently underway.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00195, 2032493-2018-00196, 2032493-2018-00197, 2032493-2018-00198, 2032493-2018-00199, 2032493-2018-00200, 2032493-2018-00201, and 2032493-2018-00203.
Event or Problem Description
It was reported that nine (9) coils were implanted in an arteriovenous (av) fistula off the right iliac artery in (b)(6) 2018.Approximately three (3) months later in (b)(6) the patient had symptomatic complaints in her pelvis again.Angiographic examination revealed the coil pack was no longer in the area of the av fistula, and had migrated to the patient's lung.Attempts were made to retrieve the coil pack over a period of 1.5 hours; however, they were unsuccessful.The patient has had no symptoms of complications in the respiratory system.The patient has been referred to a ct surgeon.The patient is currently reported to be stable.
Additional Manufacturer Narrative
The device was not returned for evaluation; however, case images were provided and reviewed.Digital subtraction angiography (dsa) fluoroscopic images and a dsa of a selective left pulmonary angiogram were provided, which demonstrate the placement of several coils in an av fistula off the right iliac artery and confirm a coil mass migration to a branch of the left pulmonary artery.There are no visible dates or text annotations on the images.The time that elapsed between initial coil implantation and coil migration cannot be determined.Based on the available information, the reported complaint is confirmed.Coil mass migration was confirmed by angiography; however, the root cause cannot be determined.The instructions for use (ifu) identifies coil migration or misplacement as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Additional/clarifying information was received from the physician, (b)(6), on november 7, 2018: "the patient was treated for "pelvic venous congestion syndrome." coil embolization of her left ovarian vein was initially done using your [terumo] coils.She returned to our outpatient clinic with similar symptoms and underwent a second procedure to interrogate the previously placed coils and evaluate for additional venous collaterals.The patient had additional enlarged low flow pelvis "venous" collaterals.There was no av fistula identified.The coils were deployed successfully within the aforementioned pelvic collaterals.The patient reported her symptoms had resolved on her post procedural follow up exam a week later.Her symptoms returned 2 months later when she returned to my clinic.The coils were oversized on initial placement, using terumo venous guidelines." based on the additional information provided, the image review was revised: digital subtraction angiography (dsa) fluoroscopic images and a dsa of a selective left pulmonary angiogram were provided, which demonstrate the placement of several coils in an unknown vessel in the pelvis, and confirm a coil mass migration to a branch of the left pulmonary artery.There are no visible dates or text annotations on the images.The time that elapsed between initial coil implantation and coil migration cannot be determined.No other changes were made to the investigation conclusions provided in the mdr follow-up 1 report that was submitted on 23-oct-18.The instructions for use (ifu) identifies coil migration or misplacement as a potential complication associated with use of the device.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7916753
• Report Number: 2032493-2018-00202
• Device Sequence Number: 1499751
• Product Code: HCG
• UDI-Device Identifier: 00810170017971
• UDI-Public: (01)00810170017971(11)161101(17)211031(10)161101LC2
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2018

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: 10/31/2021
• Device Model Number: 45-480815
• Device Catalogue Number: 45-480815
• Device Lot Number: 161101LC2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 08/28/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/23/2018; 11/12/2018
• 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: 33 YR