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

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

Patient Problems Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Perforation (2001); Insufficient Information (4580)

Event Date 01/21/2023

Event Type  Injury  

Event Description

A journal article was submitted for review titled 'clinical research of drug-coated balloon after rotational atherectomy for severe coronary artery calcification'.The aim of this retrospective study was to compare the efficacy and safety of rotational atherectomy (ra) assisted percutaneous coronary interventions (pci), using drug-coated balloons (ra/dcb), versus ra using drug eluting stents (ra/des), in treating severe coronary artery calcification (cac), and provide new evidence for addressing this stent-less strategy.From (b)(6) 2018 to (b)(6) 2021, consecutive patients who underwent ra followed by dcb or des were enrolled.A total of 318 patients who fulfilled the inclusion criteria were included in the study.Fifty-seven patients were treated with dcb after ra, and 261 were treated with des.All patients in the ra/dcb group used paclitaxel coated non-medtronic (mdt) balloons.Medtronic resolute integrity des devices were among different new generation des used in the ra/des group.There were 332 consecutive lesions from 318 patients who underwent ra.Treated lesions included lesions in the left main (lm), left anterior descending artery (lad), left circumflex artery (lcx) and the right coronary artery (rca).Lesion characteristics included chronic total occlusion, bifurcation and triple vessel disease.The primary endpoint was major adverse cardiovascular and cerebrovascular events (macce) at follow-up, which was defined as the composite of all-cause death, non-fatal myocardial infarction (mi), target lesion revascularization (tlr), and stroke.Pre and post pci, all patients were treated with dual antiplatelet therapy (dapt).Ra was performed using a non-mdt device.After ra, pre-dilatation using a semi-compliant, non-compliant, or cutting balloon is left to the judgment of the operator in charge.If needed, several dess or dcbs were applied to cover the whole stenotic segment.The dcb was dilated for at least 30¿60 seconds at nominal pressure and used only in cases without flow-limiting dissection and severe vessel recoil.Upon procedure completion, final angiography of the vessel was performed in at least two orthogonal views that showed the target site to be free of foreshortening or vessel overlap.Rescue des implantation was recommended in the case of flow-limiting dissections after dcb treatment.Follow-up data was collected by telephone interviews after pci and through the hospital¿s electronic medical record system when patients returned for further consultation.The follow-up period of the ra/dcb group was 15.0 months, while that of the ra/des group was 22.0 months.Procedural complications in the ra/des group included 2 perforations, and 1 episode of hypotension.In-hospital events and long term follow up included all-cause mortality, mi, stroke and tlr.Macce and tlr occurred more frequently in the ra/ des group, but the differences were not statistically significant.

Manufacturer Narrative

Title: clinical research of drug-coated balloon after rotational atherectomy for severe coronary artery calcification year: 2023 reference: doi.Org/10.1186/s12872-023-03071-8 a2: average age a3: majority gender b3: date of publication 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

Additional information: annex d 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 INTEGRITY 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: 18436026
• MDR Text Key: 331867046
• Report Number: 9612164-2024-00027
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/02/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Male