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

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Title: total transcatheter stage.A word of caution author: stephen nageotte, shabana shahanavaz, pirooz eghtesady.Journal: pediatric cardiology year: 2021.Vol/issue: 42.Ref: (b)(4).Average age.Majority gender.Date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.Report source: pma/5109(k) mvp 5q (k141313) and mvp 7q (k150108) used also used during procedures: unknown which size patient received.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted reviewing a case series of 6 patients who underwent a percutaneous modified stage 1 approach using modified microvascular plugs (mvp).The initial procedure was technically successful with single-stage ductal stenting and placement of bilateral modified mvp via femoral access.Patient case report details were included for a patient with hypoplastic left heart syndrome (hlhs).Final angiography demonstrated that the rpa device migrated distally after released and crossed the upper lobe takeoff.Norwood+sano performed 2 weeks post intervention with the mvp device.The patient underwent a repeat catheterization for concern of over circulation where the initial devices were removed and larger devices with smaller fenestrations were placed to provide more restriction to pulmonary blood flow.Despite this, the patient remained over circulated and was taken to the or for a norwood procedure several days later.The intervention is reported 2 weeks post mvp implant.The patient struggled with pulmonary blood flow immediately after glenn surgery and was found to have left pulmonary artery (lpa) stenosis after device removal necessitating implantation of a stent.Patient now reported as doing well 8 months since glenn procedure.Patient was 3 weeks at follow-up catheterization.

Manufacturer Narrative

Additional information: the gender breakdown of patients were an even mix.The device migrated distally in several patients.The author has stated that this is not viewed as a device "malfunction", but rather a use of device for this situation not being adequate 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: MICROVASCULAR PLUG
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway; ste, 167; irvine CA 92618
• Manufacturer (Section G): REVERSE MEDICAL; 13700 alton parkway; ste, 167; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12438303
• MDR Text Key: 280748151
• Report Number: 3007170829-2021-00022
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• 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): Required Intervention
• Patient Weight: 3 KG