MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; CORONARY DRUG-ELUTING STENT

Catalog Number RONYX40008UX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

Title: case report: catheter-based mechanical thrombectomy using the indigo aspiration system in a case of systemic-to-pulmonary shunt thrombosis.Authors: natalie soszyn, gareth j.Morgan, john s.Kim and jenny e.Zablah.Journal name: frontiers in pediatrics year: 2023 reference: doi 10.3389/fped.2023.1114044 b3: date of publication 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.

Event Description

A journal article was submitted for review titled "case report: catheter-based mechanical thrombectomy using the indigo aspiration s ystem in a case of systemic-to-pulmonary shunt thrombosis".This article describes a case report of a patient with central shunt thrombosis in the setting of pulmonary atresia, where novel use of an aspiration system allowed safe and effective removal of a thrombus from the central shunt and left pulmonary artery (lpa), facilitating stent placement in the narrowed lpa.The patient underwent stage i palliation with a 3.5mm aortopulmonary polytetrafluoroethylene (ptfe) graft shunt from the proximal aortic arch to the main pulmonary artery, atrial septectomy and bilateral branch pulmonary artery patch augmentation on the sixth day of life.The postoperative course was complicated by ectopic atrial tachycardia and desaturation, secondary to multilevel airway obstruction with mild supraglottic edema, laryngomalacia and left vocal cord paralysis.A ct scan was performed and demonstrated near complete occlusion of the lpa and narrowing of the left main stem bronchus.Angiography demonstrated a non-occlusive thrombus in the distal central shunt, and a thrombus with complete occlusion of the lpa.Following multidisciplinary discussion with cardiovascular surgeons, the decision was made for the patient to undergo cardiac catheterization to recanalize the shunt and lpa and place a stent in the narrowed lpa.A non-medtronic (mdt) aspiration system was used to remove the thrombus from the central shunt and lpa allowing placement of a stent in the narrowed lpa.An 0.014 non-mdt wire was then used as the working wire over which to advance a 4 × 8mm resolute onyx coronary drug-eluting stent (des) and was positioned across the area of lpa stenosis.The balloon was inflated to 14 atm and the stent was deployed in the lpa.Angiography demonstrated antegrade flow to the distal lpa with significant diameter improvement of the central shunt and the lpa.Following the procedure, the patient was commenced on a continuous unfractionated heparin infusion on the night following the procedure and then transitioned to therapeutic-dose subcutaneous low-molecular-weight heparin in conjunction with aspirin until the second-stage palliation procedure.Follow-up echocardiography demonstrated a patent central shunt with improved flow through the lpa stent and no evidence of a residual thrombus or distal thrombus.Follow-up ct was not performed due to the clinical improvement of the patient following the procedure.The patient was discharged 6 days post procedure with no neurological sequelae, and successfully underwent second-stage palliation at 4 months of age.At the time of the patients second stage palliation, the lpa was hypoplastic and the lpa stent had evidence of previous thrombosis and profound intimal irregularities.The stent was therefore removed, and the lpa was augmented using a circular non-mdt pulmonary patch.

Manufacturer Narrative

Additional information: annex d codes.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: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16813194
• MDR Text Key: 313989139
• Report Number: 9612164-2023-01767
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX40008UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• 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): Required Intervention
• Patient Age: 53 DA
• Patient Sex: Female
• Patient Weight: 3 KG