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

Model Number	45-480420
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Chest Tightness/Pressure (2463); Vascular System (Circulation), Impaired (2572)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.The device was used during the same procedure as was reported in mfr.Report number 2032493-2019-00121, 2032493-2019-00122, 2032493-2019-00123, and 2032493-2019-00125.
Event or Problem Description
It was reported that a patient underwent surgical intervention due to coil migration, to surgically remove a previously implanted cook stent zilver or coil fragments.In the afternoon of (b)(6) 2017, the patient called the physician complaining of shortness of breath and chest discomfort.The physician directed the patient to present himself to the (b)(6) medical center emergency room.At the emergency room, doctors performed a battery of tests and scans.Tests showed that the cook biliary stent and terumo azur coil dr.(b)(6) had previously implanted had failed.Instead of staying in place, the zilver stent and coil had moved and were obstructing his right atrium, the right-hand side of his heart.To be sure, one of the stent's coils that was in his pelvis was now in a tertiary pulmonary artery on the right side of the patient's heart furthermore, an x-ray showed that there was a coil in the patient's right lung.Dr.(b)(6) elected to remove the failed stent and azur coil.The patient was subjected to anesthesia and a lengthy procedure to remove the stent and coil debris.After the procedure, the patient was sent to the icu for observation.The following morning, a ct scan showed that the physician and his team had missed a stent fragment in the patient's right heart that still placed his life and well being in danger.The physician determined that the patient was stable enough that he could wait to be seen by the cardiothoracic and cardiology surgeon.On (b)(6)2017, a cardiothoracic and cardiology surgeon evaluated the patient and noted that his condition had failed to improve and that some stent and/or coil fragments were still lodged in the heart, and further surgery was deemed necessary.It was recommended that the patient undergo open bypass surgery to remove the fragments in his heart.Dr.(b)(6) untangled the metallic stent struts and/or coil debris that were lodged in patient's right ventricle.During the surgery, dr.(b)(6) encountered and removed two stent and/or coil fragments, one measuring approximately lcm in diameter, and the other 0.75cm.The patient was discharged from the hospital on (b)(6) 2017.

• 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: 8586910
• Report Number: 2032493-2019-00124
• Device Sequence Number: 1836667
• Product Code: HCG
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)161216(17)211130(10)161216LC9
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• 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): 04/08/2019

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 45-480420
• Device Catalogue Number: 45-480420
• Device Lot Number: 161216LC9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/07/2019
• 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: Life Threatening; Other; Required Intervention
• Patient Age: 46 YR