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 Stroke/CVA (1770); Myocardial Infarction (1969); Perforation (2001); Vascular Dissection (3160)

Event Date 04/03/2022

Event Type  Injury  

Event Description

A journal article titled - long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (deb-dragon registry) - was submitted for review.The deb-dragon registry is a large multi-centre observational study conducted at eight high-volume pci centres.The aim of this study was to use the deb-dragon registry to evaluate the relationship between long-term outcomes and the length of dual antiplatelet therapy (dapt), in patients treated with percutaneous coronary intervention (pci), due to drug-eluting stent restenosis (des-isr) with drug-eluting balloons (deb) or des.The primary efficacy end-point was target lesion revascularisation (tlr).The secondary end-points were device-oriented adverse cardiac events (device oriented composite endpoints (doce), defined as a composite of cardiac death, tlr, and target vessel mi), target vessel revascularisation (tvr), myocardial infarction (mi), death and stroke.The medtronic resolute des was among the des devices used in this study, while the medtronic in.Pact falcon deb was among the deb's used.Prior to their procedures patients presented to hospital with a number of different clinical presentations including chronic coronary syndrome, unstable angina, st elevated mi (stemi), non-stemi and in cardiac arrest.Intra operative complications included coronary artery perforation, coronary artery dissection and no-reflow phenomenon.Post operatively patients were divided according to the duration of dapt into 4 groups: = 3 months and > 3 months, and = 6 months and > 6 months.Afterwards, patients were matched according to propensity score and the study included a total of 107 patients treated with dapt = 3 months and 107 patients > 3 months, as well as 269 patients treated = 6 months with dapt and 269 > 6 months.The current analysis demonstrated that treatment with dapt in patients with des-isr is related to better long-term outcomes in the case of pci with des than deb, independently of dapt duration.Dapt > 6 months is related to a higher stroke rate, independently of treatment type (des and deb).

Manufacturer Narrative

Journal article: long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (deb-dragon registry) authors: rafal januszek, jacek bil, natasza gilis-malinowska, et.Al.Journal: advances in interventional cardiology year: 2022 reference: doi: https://doi.Org/10.5114/aic.2022.115631 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 death(s) was provided.Age: average age.Sex: majority gender.Date of event: 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.

• 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: 15072937
• MDR Text Key: 296291150
• Report Number: 9612164-2022-02766
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 07/21/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/21/2022
• 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: 67 YR
• Patient Sex: Male