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

Catalog Number RONYX40012X

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 08/31/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled "transjugular ductus venosus stent placement in an extremely premature, low birth weight neonate with infradiaphragmatic total anomalous pulmonary venous connection".This case presents successful transjugular stent placement in the ductus venosus in a 950 g neonate, born at 26 weeks gestational age, with infradiaphragmatic total anomalous pulmonary venous connection (tapvc).After premature birth the patient was supported with nasal non-invasive ventilation until day of life (dol) 9 at which point the patient required intubation for progressive respiratory failure.An echocardiogram was performed which demonstrated a pulmonary venous confluence posterior to the left atrium, draining into a vertical vein coursing below the diaphragm, consistent with infradiaphragmatic tapvc.A patent ductus venosus (dv) was visualized with an initial gradient of 2.4 mmhg.By dol 15, the dv gradient had increased to 5 mmhg, with persistent pulmonary edema and intermittent hypotension requiring dopamine infusion.Dv stent placement was performed on dol 17 at a weight of 1 kg.4fr sheaths were placed in the right internal jugular vein (rij) to access the ductus venosus and in the left femoral vein (lfv) to concomitantly access the left pulmonary artery (lpa) for angiography of pulmonary venous return.An end-hole catheter was advanced prograde to the lpa from the lfv for angiography.This demonstrated that the left pulmonary veins drained to a vertical vein which coursed caudally and entered the right portal vein.The dv was only faintly seen given the lack of flow due to severe constriction.From the rij sheath, the dv was accessed using a 1.8f non-medtronic (mdt) microcatheter and a 0.014'' non-mdt wire.Angiography demonstrated that the dv constricted to <(><<)>1 mm.The wire was positioned in the superior left portal vein and angioplasty of the dv was performed using a 3 × 8 mm non-mdt balloon, followed by placement of a 4 x 12 mm resolute onyx coronary drug eluting stent.Follow-up angiography in the lpa and portal sinus was performed and it was apparent that the stent crossed and jailed the rightward part of the portal sinus where the vertical vein was draining.The region of portal sinus connecting the right portal vein and vertical vein was more posterior compared to where the wire was positioned and not as easily accessible or visualized on initial angiography.Therefore, the non-mdt microcatheter and 0.014'' wire were utilized to cross the side cell of the existing stent and access the right portal vein and vertical vein.Angioplasty of the side cell was performed using a 3 x 8 mm non-mdt balloon and the4 mm balloon from the previously placed stent.During catheter and sheath manipulation, it was noted that the existing stent distorted with residual obstruction in the dv.A 4 × 16 mm non-mdt stent was implanted across the dv, extending into the right side of the portal sinus allowing for unobstructed return from the vertical vein.Follow-up angiography demonstrated robust flow from the vertical vein to the right atrium via the stented dv.The systemic arterial pressure markedly increased after placement of the second stent corresponding to adequate drainage of pulmonary venous return.Post-procedure, the patient had significant improvement in lung compliance and pulmonary edema.The patient was anticoagulated with low dose heparin for 72 hours, followed by aspirin monotherapy due to elevated risk of intraventricular hemorrhage with prematurity.The patient was also maintained on rifaximin to normalize elevated ammonia levels in the setting of the patent portosystemic shunt.One month following the initial intervention, the patient developed lactic acidosis.There was concern for inadequate atrial shunting, so the patient underwent balloon atrial septostomy.Two weeks later, the patient developed frequent desaturations with elevated right ventricular pressure by echo.The patient returned for cardiac catheterization where a 6 mmhg gradient was noted across the stent and underwent balloon dilation of the stent with 4 and 5 mm balloons with reduction to a 4 mmhg gradient.Two months after the initial intervention, at a corrected gestational age of 37 weeks and weight of 2 kg, the patient underwent successful surgical tapvc repair.At 4 months of age, the patient remained on rifaximin due to intermittently elevated ammonia levels and underwent cardiac catheterization to embolize the stented ductus venosus with a 4 × 4 mm non-mdt device.Right ventricular systolic pressure was 26 mmhg and mean pulmonary artery pressure was 19 mmhg.Angiography demonstrated that the left portal vein was occluded as a consequence of prior intervention.The patient was ultimately discharged from the hospital at 5 months of age.On most recent follow-up at 19 months of age, the patient continues to do well.The patient's echocardiogram demonstrates unobstructed pulmonary venous return and right ventricular pressures are estimated to be normal.

Manufacturer Narrative

Title: transjugular ductus venosus stent placement in an extremely premature, low birth weight neonate with infradiaphragmatic total anomalous pulmonary venous connection authors: julian e.Cameron, sarah badran, john cleveland, neil d.Patel.Journal name: progress in pediatric cardiology year: 2022 reference: doi.(b)(4).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.

Manufacturer Narrative

Additional information: it was later reported that no adverse event was directly attributable to the resolute onyx stent.The issues encountered during stent implantation were based on procedural technique and a complex anatomy.The subsequent repeat balloon dilation of the stent at a later date is quite common and expected in neonates given their relative somatic growth.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: 16641678
• MDR Text Key: 312284820
• Report Number: 9612164-2023-01352
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX40012X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• 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: 17 DA
• Patient Sex: Male
• Patient Weight: 1 KG