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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Hemorrhage/Bleeding (1888); Ischemia (1942); Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

Title: safety and efficacy of a hybrid approach combining a paclitaxel-coatedballoon with a new generation drug-eluting stent in pat ients with denovo true coronary bifurcation lesions year: 2023 reference: doi.Org/10.1016/j.Carrev.2023.04 a2: average age a3: majority gender b3: date of publication medication: clopidogrel 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.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; safety and efficacy of a hybrid approach combining a paclitaxel-coated balloon with a new generation drug-eluting stent in patients with de novo true coronary bifurcation lesions.The aim of this prospective non-randomized interventional single center study was to assess the safety and the efficacy of a hybrid strategy combining a drug eluting stent (des) in the main branch (mb), and a drug-coated balloon (dcb) to treat the side branch (sb) ostium, as an alternative to the 2-stent techniques in patients with de novo true bifurcation lesions.From september 2020 to march 2022, 45 patients were enrolled.The initial clinical presentation in the patients were either st segment elevation myocardial infarction (stemi), non-st segment elevation myocardial infarction (nstemi) or chronic coronary syndrome, including silent ischemia.Multi-vessel disease was present in 57.8 % of the patients.Lesions were mostly located in the left anterior descending artery (lad).Only 2 patients had a lesion localized in the distal left main.Other lesions were located in the left circumflex, obtuse marginal and distal right coronary artery.All patients underwent a percutaneous coronary intervention (pci) with the hybrid approach.The dcb used was a non-medtronic device, while the medtronic resolute onyx was among a number of other non-medtronic the dess used during the procedures.Coronary guide wires were passed to the mb and sb.First, the sb was pre-dilated by a semi-compliant (sc) or a non-compliant (nc) balloon.In case of pre-dilation success defined by residual diameter stenosis 30 % without major dissection type c or higher, the side branch ostium was treated with at least 45seconds (optimally 60seconds) dcb inflation at nominal pressure.In addition, the dcb length had to extend at least 2mm beyond the sb lesion distally in order to avoid geographical mismatch.After that, the mb was pre-dilated then stented according to the diameter of the distal mb.Thereafter, proximal optimization technique (pot) had to be performed.An angiographic control was required to assess the residual stenosis at the level of the sb ostium and the absence of complications.Clinical assessment was scheduled at 6 months with clinical examination and systematic stress test with functional imaging.The primary endpoint of the study was the composite of target lesion failure (tlf) at 6 months including cardiac death, target vessel mi (tvmi) or ischemia-driven target lesion revascularization (id-tlr).The secondary endpoints were technical success, defined by performing the pci without bailout stenting of the sb ostium, and clinical success defined by a technical success without severe complications during the in-hospital phase.The technical success was obtained in 88.9 %.Only five patients required an additional des at the level of the side branch ostium.Complications that led to the sb stenting were one dissection type b at the sb ostium after dcb angioplasty followed by extension of the dissection and impairment of the sb flow after mb stent implantation which occurred in 3 patients, and residual diameter stenosis >50 % at the sb ostium despite the realization of a kissing balloon, which occurred in 2 patients.Only one person in the study experienced a severe in-hospital complication.Two days later the patient developed a gastrointestinal bleeding requiring blood transfusion and endoscopic treatment of a gastroduodenal ulcer with good evolution.Three patients died of non-cardiac causes within 6 months after pci.Significant myocardial ischemia was found in 5 patients.These patients underwent a coronary angiography.Finally, only one person in the study had significant angiographic restenosis at the target lesion.Six months post procedure the patient was symptomatic with a class 3 canadian cardiovascular society (ccs) angina and stress echocardiography was positive with a large ischemia in the lad territory.The coronary angiography was performed and showed diffuse in-stent restenosis in the lad and restenosis at the level of the first diagonal ostium.A surgical revascularization was finally indicated.No cardiac death or tvmi were observed.At six months, no side branch thrombosis was observed.

Manufacturer Narrative

Additional information: annex d code.Correction: patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.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: STENT, CORONARY, DRUG-ELUTING
• 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: 18374306
• MDR Text Key: 331179880
• Report Number: 9612164-2023-06143
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• 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): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male