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 Hemorrhage/Bleeding (1888); Failure of Implant (1924)

Event Date 07/17/2020

Event Type  Injury  

Event Description

Zobel mj, moses w, walther a, et al.Management challenges of a large upper extremity vascular malformation in a patient with capillary malformation-arteriovenous malformation syndrome.Journal of vascular surgery venous and lymphatic disorders.2021;9(3):781-784.Doi:10.1016/j.Jvsv.2020.07.001.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to present a case of a young man with a massive combined vascular malformation of the right chest wall, shoulder, and arm that failed to respond to an aggressive embolization strategy and ultimately required a staged resection in conjunction with a modified shoulder disarticulation preceded by surgical occlusion of vascular supply.The patient was clinically diagnosed with parkes weber syndrome shortly after birth and had undergone numerous transcatheter embolization procedures with both endovascular coils and onyx (ethylene vinyl alcohol; ev3, irvine, calif) beginning at the age of 5 years.Despite repeated intervention, no improvement was noted, but rather an increase in the growth of the malformation was observed.As a teenager, he had experienced spontaneous massive hemorrhage from a cutaneous ulceration on the lateral aspect of his shoulder that required multiple transfusions and abated only after emergent embolization.Computed tomography angiography of the chest was performed soon after presentation, demonstrating innumerable feeding vessels emanating from the branches of the right subclavian artery, which itself measured >2.5 cm in diameter.Given the extent of his lesion, he was initially treated with interstitial injections of bleomycin and a trial of sirolimus, neither of which improved the extent or severity of the malformation.Skin ulceration worsened over time and resulted in recurrent episodes of massive bleeding, requiring prolonged admission with repeated large-volume transfusions and doses of recombinant factor vii.Given the unpredictability and severity of the recurrent bleeding episodes, despite the aforementioned interventions, the decision was made to proceed with a modified shoulder disarticulation, which was preceded by median sternotomy and surgical ligation of the subclavian artery and innominate vein.Although forequarter amputation was the initial planned procedure, extraordinary blood loss was encountered during the division of tissue affected by the avm, which limited the extent of resection to a shoulder disarticulation.After recovering well from this operation and experiencing no additional episodes of hemorrhage, he underwent staged resection of the residual anterior chest wall component of the avm with rotational transverse rectus abdominis myocutaneous flap coverage.Not unexpectedly, repeated computed  tomography angiography has demonstrated residual avm, and the flap developed an area of superficial ulceration at the wound margin, but he has not required any additional treatment and has not had additional bleeding episodes in the year since the initial procedure.In this case, the numerous transcatheter interventions performed at outside hospitals before his presentation not only failed to slow the growth of the malformation but also may have worsened the patient¿s disease burden by stimulating neoangiogenesis while simultaneously closing off the direct arterial pathways and forcing the formation of innumerable collateral pathways.

Manufacturer Narrative

G2: citation: authors: zobel, m.J., moses, w., walther, a., nowicki, d., howell, l., miller, j., zeinati, c., & anselmo, d.M.Management challenges of a large upper extremity vascular malformation in a patient with capillary malformationarteriovenous malformation syndrome.Journal of vascular surgery.Venous and lymphatic disorders 3 2021.Doi:10.1016/j.Jvsv.2020.07.001.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 17737110
• MDR Text Key: 323286410
• Report Number: 2029214-2023-01685
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

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: 08/17/2023
• Initial Date FDA Received: 09/13/2023
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male