MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-ONYX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Septic Shock (2068); Obstruction/Occlusion (2422); Respiratory Failure (2484); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Date 03/04/2022

Event Type  Death  

Manufacturer Narrative

G2: citation: authors: smith, z.T., haines, j., calkins, e., fox, j., scriver, g., morris, c.S.Transcatheter coil embolization of a complex pulmonary artery pseudoaneurysm with thyrocervical trunk-pulmonary arterial fistulization in a patient with cystic fibrosis and massive hemoptysis.Radiology case reports 17(6):1836-1842 2022.Doi:10.1016/j.Radcr.2022.03.024 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Smith zt, haines j, calkins e, fox j, scriver g, morris cs.Transcatheter coil embolization of a complex pulmonary artery pseudoaneu rysm with thyrocervical trunk-pulmonary arterial fistulization in a patient with cystic fibrosis and massive hemoptysis.Radiology case reports.2022;17(6):1836-1842.Doi:10.1016/j.Radcr.2022.03.024.Medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to report a successful transcatheter coil embolization of a complex pulmonary artery pseudoaneurysm (pap) with a thyrocervical trunk-pulmonary arterial fistula in a patient with massive hemoptysis in the setting of advanced cystic fibrosis (cf).The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted: a patient with recurrent hemoptysis was presented for embolization treatment.The microcatheter and wire were advanced into the laterally directed distal branch of the left thyrocervical trunk and an angiogram showed numerous collaterals feeding the systemic to pulmonary arterial fistula.This was embolized to stasis with onyx.A postembolization angiogram showed no flow across the systemic to pulmonary arterial fistula supplied by this lateral branch of the left thyrocervical trunk.The microcatheter was withdrawn and was then used to select a superior medially directed branch of the left thyrocervical trunk.An angiogram from this microcatheter position showed a tortuous systemic to pulmonary arterial fistula supplying the pseudoaneurysm.Multiple attempts were made to cannulate the distal portion of this left thyrocervical trunk branch.This resulted in dissection and occlusion of this artery.A post dissection angiogram showed stasis within this superior medially directed branch of the left thyrocervical trunk.Through the femoral v ein sheath, a 7 french angled pig-tail catheter was then reinserted into the left main pulmonary artery and repeat left pulmonary arterial angiogram showed no newly visible pulmonary arterial supply to the pseudoaneurysm or persistent flow to the previously identified and embolized systemic to pulmonary arterial fistulae.The patient tolerated the procedure well and was transferred back to the medical intensive care unit (micu) in stable condition.The patient¿s hemoptysis improved, and she was extubated the following day.However, her clinical course was complicated by septic shock related to her cf exacerbation.Sputum cultures grew burkholderia cepacian complex, precluding lung transplantation.Eventually, she was weaned off vasopressors and transferred out of the micu, remaining hemoptysis-free for 11 days.An additional isolated hemoptysis recurrence prompted transfer back to the micu.A repeat computed tomography angiogram (cta) at that time did not show any active extravasation, although it did show continued enhancement of the pseudoaneurysm in the left lung apex.One week later the patient developed recurrent massive hemoptysis requiring intubation.Repeat cta redemonstrated the 8-9 mm pseudoaneurysm in the medial left upper lobe without evidence of active extravasation, but with altered m orphology compared to the most recent prior cta.The decision was made to proceed with repeat embolization.Coil embolization of this systemic arterial feeding artery, the pseudoaneurysm itself, as well as the distal pulmonary artery branch was performed.A post e mbolization angiogram revealed stasis within the pap and its feeding arteries.The patient tolerated the procedure well, without any immediate post procedure complications.Although the procedure was successful technically, the patient continued to deteriorate clinically, requiring increased respiratory support with maximal ventilator settings and pressor support.On post-procedure day four, the family made the decision to transition to comfort measures only due to poor prognosis.The patient expired shortly thereafter with the cause of death being acute respiratory failure due to burkholderia cepacian infection, a complication of her cystic fibrosis.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17821844
• MDR Text Key: 324318868
• Report Number: 2029214-2023-01858
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female