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

Catalog Number RONYX27518UX

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Perforation (2001); Insufficient Information (4580)

Event Date 11/08/2021

Event Type  Injury  

Event Description

A case study was submitted for review titled "complications of stent loss during treatment of a heavily calcified and tortuous chronic total occlusion".The patient had presented with non-st segment elevation acute myocardial infarction (nstemi) due to 90% stenosis of the proximal anastomosis of the saphenous vein graft (svg) to the first obtuse marginal branch (om1) (svg-om1).The patient was treated with a balloon angioplasty due to the need for hip surgery.Three months later, the patient was subsequently referred for a percutaneous coronary intervention (pci) of the native om1 with chronic total occlusion (cto).Bilateral femoral arterial access was obtained and the left main was engaged with a 8fr ebu guide catheter and the svg-om1 was engaged with an 8fr al1 guide catheter.Antegrade wiring was performed with a non mdt microcatheter and two non mdt guidewires without success due to proximal cap ambiguity.A non mdt catheter and microcatheter and various non mdt guidewires were used for retrograde crossing but were unsuccessful.Because of the severe stenosis and calcification into the circumflex, a 3.0 × 15 mm non mdt balloon was inflated in the proximal circumflex facilitating the advancement of a retrograde non mdt guidewire into the antegrade guide catheter, using the reverse controlled antegrade and retrograde tracking (reverse cart).Placement of two resolute onyx drug eluting stents restored antegrade flow into the om1.Due to significant competitive blood flow between the svg and om1, the svg was occluded using a 6 mm non mdt vascular plug.Repeat angiography and intravascular ultrasound (ivus) confirmed a significant stenosis proximal to the svg to om1 distal anastomosis.An attempt was made to deliver a 2.75 × 18 mm resolute onyx stent to the lesion without success.The stent came off the balloon during withdrawal in the proximal circumflex.The small balloon technique was used with a 1.5 × 15 mm balloon in an attempt to retrieve the lost stent, but it failed.The stent was crushed with a 3.0 × 20 mm balloon and additional lesion pre-dilation was performed.A 2.75 × 15 mm non mdt drug eluting stent was subsequently delivered and deployed successfully treating the stenosis proximal to the svg-om1 distal anastomosis.However, the previously crushed resolute onyx stent migrated distally.A 2¿4 mm non mdt snare was used in an attempt to retrieve the stent, but removal failed due to severe resistance to stent withdrawal.Coronary angiography revealed a large vessel perforation.A 3.0 × 15 mm non mdt covered stent was delivered and deployed to cover the lost stent and seal the perforation.The patient had an uneventful recovery.

Manufacturer Narrative

Title: complications of stent loss during treatment of a heavily calcified and tortuous chronic total occlusion year: 2022 reference: doi.Org/10.1016/j.Carrev.2021.11.013 average age, majority gender, 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

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: 15787899
• MDR Text Key: 303565605
• Report Number: 9612164-2022-04217
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX27518UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/01/2022
• 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: 72 YR
• Patient Sex: Male