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

Model Number RONYX22526UX

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problems Myocardial Infarction (1969); Anxiety (2328); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 02/06/2023

Event Type  Injury  

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.

Event Description

A patient had four resolute onyx coronary drug eluting stents implanted.It was reported that the patient experienced what was thought to be a heart attack and attended the ed (emergency department).It was discovered through imaging that one of the resolute onyx stent's had fractured.A non-medtronic stent was implanted inside the fractured stent.No further patient injury was reported.

Manufacturer Narrative

Additional information: the four resolute onyx stents were implanted in april 2022.Approximately 11 months later the patient showed signs of another heart attack.The fractured stent was ballooned and a non-medtronic stent was implanted inside the fractured stent to open the blockage.Patient initials updated.Medical history updated.Correction: patient gender.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: the implanted device caused another heart attack.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: the index procedure was performed for chronic total occlusion (cto) of the right coronary artery (rca).The vessel had been stented from the ostium to the distal segment at the bifurcation of the right posterior descending artery (rpda) and posterolateral artery (pla).The 2.5 x 38mm resolute onyx stent was inflated to 14 atm, the 3.0 x 38mm resolute onyx stent was inflated to 12 atm, the 3.0 x 30mm resolute onyx stent was inflated to 15 atm, and the 2.25 x 26mm resolute onyx stent was inflated to 10 atm followed by the balloon at 24 atm.A 3.0 x 30mm non-medtronic balloon was used for post-dilation up to 22 atm as well as a 2 x 15mm balloon up to 10 atm.All stent balloons successfully deflated post stent dilation.There were no difficulties noted during the removal of the guidewire.The balloon or the delivery system did not snag on the deployed stents.There were no difficulties during stent deployment and there were no complications.A recent coronary angiogram was performed for unstable angina demonstrating severe 90% in-stent restenosis (isr) of the distal segment of the rca with possible stent fracture.The ostial/proximal previously implanted stent appears under-expanded with mild-moderate isr.The focal mid-segment appears under-expanded and there is focal isr in the distal segment near a hinge point with suspected stent fracture.There was timi grade 3 flow across the lesion.The patient went for a follow-up percutaneous interventional procedure.It was detailed that right common femoral artery access was obtained suing fluoroscopic and ultrasound guidance.First in the distal rca, balloon angioplasty was performed with a 2.5 x 20 non-medtronic (mdt) nc balloon.The balloon was placed across the lesion and given a single inflation with a maximum inflation pressure of 20 atm.The balloon expanded well.Using a non-mdt intravascular ultrasound (ivus), stent fracture could not be identified definitively.The resolution of the ivus system was insufficient to determine the mode of stent failure and isr.Optical coherence tomography (oct) and high definition (hd) ivus was not available.After balloon expansion a non-mdt guide extension catheter was used to help place and deploy a 3.5 x 24mm non-mdt stent.The stent was deployed with a single prolonged inflation and a maximum pressure of 11 atm.Ivus was repeated, and the stent diameter was 2.5mm, under-expanded.Balloon angioplasty with a 3.0 x 15mm non-mdt balloon was performed across the lesion, with a single inflation of a maximum 18 atm inflation pressure.Again, balloon angioplasty was performed across the lesion with a 3.5 x 20mm non-mdt balloon, given four inflations with a maximum inflation pressure of 22 atm.The stent was post-dilated up to 22 atm.Following intervention, there was 0% residual stenosis and timi grade 3 flow (brisk flow).There was no dissection.For the previously implanted stent the areas of under expansion in the mid and ostial-proximal vessel were also ballooned using a 3.5mm nc balloon at 22 atm.Finally, the ostial/proximal and mid segments were balloon using a 4.0mm nc balloon to 18 atm, including flaring the ostium.There was also noted to be 50% stenosis in the proximal rca with timi grade 3 flow across the lesion.Balloon angioplasty was performed with a 4.0 x 15mm non-mdr nc balloon.The balloon was given five inflations up to a maximum pressure of 18 atm.Following intervention, there was 0% residual stenosis and timi grade 3 flow (brisk flow).There was no dissection.Event date updated.Patient medical history batch details patient age <(>&<)> weight 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: during the index procedure, the lesion was crossed in an antegrade approach.A non-medtronic (mdt) balloon was used with a double blind stick and swap technique with a 20 and 200 non-mdt guidewires, to successfully enter the distal true lumen.The lesion was ballooned restoring timi 3 flow, but there was poor flow distally that was at the bifurcation of the pda and posterolateral vessel (plv).Three of the resolute onyx drug eluting stents were used from the distal rca all the way to the ostium, but there remained poor flow.A non-mdt dual lumen microcatheter and reversed guidewire technique were used to wire into the right posterolateral.A kissing balloon inflation with 2.0 mm balloons was performed.With intravascular ultrasound (ivus), it demonstrated there was disease into the pda and the distal rca, so this was covered with an additional 2.25 x 26 mm resolute onyx stent, that was post dilated proximal to the bifurcation with a 3.0 mm balloon.In the end, there was excellent final result with timi 3 flow into the pda as well as the right posterolateral branch.Annex d code.Correction: no device detachment occurred, corresponding annex a code removed.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: using a non-mdt ivus and cineangiography, stent fracture could not be identified definitively.The ostial/proximal and mid rca previously implanted stents appeared under-expanded.A launcher guide catheter was used during the procedure.It was later reported that the patient is dealing with new cardiac issues that are being addressed.Annex e code.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: 16553153
• MDR Text Key: 311399124
• Report Number: 9612164-2023-01159
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/24/2023

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 Model Number: RONYX22526UX
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0011090025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 04/27/2023; 06/01/2023; 06/14/2023; 10/28/2023
• Supplement Dates FDA Received: 04/25/2023; 05/25/2023; 06/14/2023; 07/05/2023; 11/24/2023
• Date Device Manufactured: 02/24/2022
• 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): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 87 KG