MAUDE Adverse Event Report: COVIDIEN MICROVASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number MVP-7Q

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2022

Event Type  Injury  

Event Description

Medtronic received a journal article titled "management of a large coronary artery fistula in a neonate".An mvp-7q device was used off label use in a neonate for treatment of the coronary artery.It reports a case of a 2.6-kg female patient born at 39 weeks was found to have a murmur.Echocardiography revealed diffuse dilation of the right coronary artery (rca), a large fistulous connection between the rca and the right ventricle (rv) outflow tract, 3 small left-to-right atrial shunts, normal left ventricular size and function, a mildly dilated rv with normal function and holodiastolic flow reversal in the aortic arch.Computed tomography angiography detailed the fistulous connection between the rca and rv infundibulum, measuring 0.7 3 0.58 cm cardiac catheterization further illustrated the fistula, measuring 0.7 3 1.09 cm, as well as a normal size and course for the rca distal to the fistula.Due to persistently low diastolic blood pressure, on day of life 4, transcatheter closure was attempted, first with a microvascular plug-7q device (mvp-7q; medtronic), which left significant residual flow through the fistula.Coil embolization was attempted, but high flow through the fistula precluded accurate coil position.Then a 12-mm amplatzer vascular plug ii (non-medtronic) was attempted, which unfortunately embolized into the rv.The device was moved to the right atrium for retrieval, resulting in severe tr noted on postprocedure echocardiography.On day of life 5, the patient was taken to the operating room for surgical repair.The fistula was too large to suture ligate externally.The entrance to the right ventricular outflow tract was visible through the tricuspid valve but not amenable to closure.Therefore, divided the epicardium overlying the fistulous tract, which revealed the coronary and ventricular openings to the fistula.The tricuspid valve was then repaired by resuspending the anterior leaflet, reimplanting a major chord to the septal wall, and performing a partial commissuroplasty.The atrial septal defect was closed primarily.Postrepair echocardiography confirmed no residual fistulous connection, mild-to moderate tr, and a tiny residual atrial level shunt.Postoperative course was uneventful.The patient was extubated and weaned off inotropes and vasoactive support by postoperative day (pod) 4.Follow-up echocardiography showed 2 tiny additional rca fistulas to the rvand moderate tr.She tolerated gastric feeds well and was transitioned to oral afterload reduction.Intravenous therapeutic heparin was initiated on pod 0.She was transitioned to therapeutic lovenox (enoxaparin) on pod 6 and then discharged home on pod 11 on aspirin and lovenox.At 6 months¿ postoperatively, she continued to develop normally, with adequate weight gain.Follow-up echocardiogram showed no residual cafs, a small pfo, and trace-to-mild tr.Repeat computed tomography angiography showed no residual fistulas and mild lobular irregularity of the proximal-mid rca 2).She was continued on aspirin and lovenox, with eventual conversion to aspirin only in the coming months.

Manufacturer Narrative

Ref: doi.Org/10.1016/j.Xjtc.2022.11.002 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.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: MICROVASCULAR PLUG
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17559974
• MDR Text Key: 321287145
• Report Number: 2183870-2023-00291
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MVP-7Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 DA
• Patient Weight: 3 KG