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

Catalog Number RONYX30015UX

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Authors: yoshinobu murasato, kyohei meno, yujiro ura, katsuhiko takenaka.Journal name: eurointervention.Year: 2022.Issue: 18.Title of article: napkin ring formation in culotte stenting using current-generation drug-eluting stents in left main coronary artery bifurcation.Literature reference: doi: 10.4244/eij-d-21-00393.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 "napkin ring formation in culotte stenting using current-generation drug-eluting stents in left main coronary artery bifurcation".This was a case study presentation of a patient who presented to hospital with non-st-elevation myocardial infarction (nstemi) and underwent primary stenting in the middle left circumflex artery (lcx).The lcx had a subtotal occlusion and 90% stenosis.One week later during the second percutaneous coronary intervention (pci), the diseased right coronary artery (rca), was treated with stent implantation.An attempt was made to implant a medtronic resolute onyx coronary drug eluting (des) stent at the proximal lcx, but failed due to the patient¿s deep breathing and accidental disengagement of the guiding catheter, causing the stent to protrude into the left main (lm) artery.Proximal optimization and kissing balloon inflation (kbi) in the lm bifurcation resulted in complete attachment of the proximal stent edge to the lm, and some opening of the jailed left anterior descending artery (lad).In the third pci intervention on the lad one month later, an optical coherence tomography (oct) catheter could not be advanced towards the lad.A three-dimensional oct (3d-oct) image of pullback from the lcx revealed that the protruded struts and four link connections of the lcx resolute onyx stent had jailed the lad ostium, with the guidewire crossing into the most proximal stent cell.Small spaces for wiring remained outside the stent for stent crush.And inside the distal regular cell for cell expansion.After successful rewiring to the distal cell, a 3.0 x 12mm non-compliant balloon was inflated at 22 atm.As the medium size of the resolute onyx stent has more link connections and smaller cells with 2-4 crowns in the proximal site, in order to maintain helical coil constitution, two consecutive smaller cells with maximal expansion capacities <(><<)>3.0 mm were aligned at the lad ostium.A 3.0 x 38mm non-medtronic des was implanted from the lm to the lad to form minimal culotte stenting.The lm and the proximal lad were dilated with a 4.0 x 8mm noncompliant balloon, and subsequent kbi with 3.0 mm and 2.5 mm balloons at 12 atm was performed.The final angiography showed acceptable results.However, oct showed a limited stent expansion area of 5.3 mm2 and remarkable malapposition, with a range of 400-700 ¿m, combined with thrombus attachment at the lad ostium.Napkin ring formation was demonstrated on 3d-oct images.

Manufacturer Narrative

Additional information: it was later reported that there was no problems at all at the follow-up after 6 months and the event was not due to the resolute onyx stent.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: 15884581
• MDR Text Key: 304506807
• Report Number: 9612164-2022-04476
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX30015UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• 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: 64 YR
• Patient Sex: Male