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

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 09/23/2022

Event Type  Injury  

Event Description

A journal article titled "long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions" was submitted for review.This prospective, non-randomized, observational study aimed to compare the long-term outcomes of drug coated balloon (dcb), [dcb alone or combined with drug eluting stents (des)], and des alone in treating diffuse coronary lesions.Consecutive patients with diffuse coronary lesions who underwent dcb and/or des between january 2015 and december 2019 were included in the study.The dcb group included 360 lesions in 355 patients, of which 142 patients (143 lesions) received the dcb only strategy and 213 patients (217 lesions) received the hybrid strategy (dcb combined with des).The des group included 831 lesions in 672 treated with des alone.The primary outcome was target lesion revascularization (tlr).The secondary outcomes were major adverse cardiac events (mace) [including target vessel revascularization (tvr), myocardial infarction (mi), and all-cause death].All patients undergoing dcb angioplasty used non-medtronic (mdt) paclitaxel coated balloons, and new generation des was used in all patients as stents combined with dcb or bailout stents.In the des group, single, long stents or multiple overlapping stents were implanted to cover the entire lesion, and new generation des was used in all the patients.Medtronic resolute integrity coronary des were amongst the stents used.Pci was performed following standard procedures.Most patients had multivessel diseases.Lesions being treated included the left anterior descending artery (lad), circumflex (lcx) and the right coronary artery (rca).Lesion characteristics also included lesions with moderate/severe calcification or chronic total occlusion (cto) noted.In the dcb group, routine pre-dilatation with a conventional balloon was performed.To achieve satisfactory lumen gain, cutting balloons, non-compliant scoring balloons, or dual-wire balloons were used at the discretion of the operators.According to lesion characteristics and pre-dilation results, the use of dcb alone or a hybrid approach of dcb and des was determined by three experienced cardiologists.If pre-dilation is satisfactory, dcb was used to cover the entire target lesions or partial lesions in case of dissection <(><<)> type c and residual stenosis = 50%.New generation des implantation was performed as part of an initial hybrid strategy combining dcb and des after lesion preparation or as bailout stents in segments with flow-limiting dissection or significant residual stenosis (>50%) after dcb angioplasty.Ten lesions in the dcb group required bailout stents (of which, seven were due to dissection type c and three were due to severe elastic recoil).Dissection only occurred after use of dcb.Clinical visits or phone calls every 3 months were used to achieve follow-up for a total of 3 years.Follow-up angiograms were performed between 9 and 12 months after percutaneous coronary intervention (pci), or when clinically indicated.Follow-up angiography was performed in 157 patients who received dcb, and 293 patients who received des alone.During hospitalization, one patient died in-hospital in the dcb group, and another patient underwent periprocedural mi due to stent thrombosis (st) in the des group.The primary outcome (tlr) rate at 3 years was 7.3% in the dcb group and 8.3% in the des group.The incidence of maceat 3 years in the two groups was similar.A 3 year follow up, tlr, tvr, mi, definite/probable st, all cause death and cardiac death were reported.

Manufacturer Narrative

Journal article: long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions journal: frontiers in cardiovascular medicine year: 2022 ref: doi:10.3389/fcvm.2022.935263 a2: average age a3: majority gender b3: date of publication 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.

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 INTEGRITY 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: 17875664
• MDR Text Key: 324972079
• Report Number: 9612164-2023-04500
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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?: Yes
• Date Manufacturer Received: 10/25/2023
• 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: 59 YR
• Patient Sex: Male