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); Myocardial Infarction (1969); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

Title: outcomes of percutaneous coronary interventions for long diffuse coronary artery disease with extremely small diameter year: 2023 reference: https:// doi.Org/10.3390/jcm12041285 a2: average age a3: majority gender b3: date of publication medication: standard-dose dual antiplatelet therapy 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; outcomes of percutaneous coronary interventions for long diffuse coronary artery disease with extremely small diameter.This study investigated the acute procedural and long-term clinical outcomes in patients with long diffuse coronary artery disease (cad) and maximal diameter of the distal segment (dsdmax) measuring =2.0 mm treated using the modified stenting technique and current-generation drug eluting stents (dess).The study sought to evaluate patient outcomes in this at-risk population and compared them with those with a distal lumen of >2.0 mm.Consecutive patients who underwent percutaneous coronary intervention (pci) at chang gung memorial hospital between january 2010 and december 2017 were screened retrospectively for eligibility.Among the screened patients, 736 were eligible for analysis.Patients with dsdmax = 2.0 mm based on the quantitative coronary analysis were categorized into the extremely small distal vessel (esdv) group (n=307, 42%), and the remaining patients were assigned to the non-esdv group (dsdmax > 2.0 mm) (n=429, 58%).Patients with simultaneous long lesions of dsdmax = 2.0 and dsdmax > 2.0 mm in different vessels were categorized into the esdv group.All interventions were performed according to standard techniques, except for the modified stent deployment technique.For lesions with a small distal luminal diameter = 2.0 mm, a modified stenting technique was used.To accommodate the oversized stent and achieve a higher lesion coverage, the segment with the largest luminal diameter of the distal vessel was considered the distal landing zone.During deployment, the stent was slowly inflated with each atmosphere every 2¿3 seconds.The initial stent deployment pressure was approximately 5¿7 atm to maintain partial stent expansion.Additional post-dilatation was performed using an appropriate-sized non-compliant (nc) balloon for different segments.To maintain the distal stent edge under-expanded, the distal 1¿2 mm of the stent was spared for post-dilation.The second-generation des used included the medtronic resolute des as well as several non medtronic (non mdt) brands of des.Treated lesion locations included lesions in the left anterior descending artery, left circumflex artery and right coronary artery.Lesion characteristics included left main coronary disease, chronic total occlusion and moderate to severe calcification.All patients were pretreated with standard-dose dual antiplatelet therapy before and after the pci procedure, according to the clinical condition and judgment of the primary care physician.Procedural success was defined as the attainment of residual diameter stenosis of =30% and thrombolysis in myocardial infarction (timi) flow grade 3 without angiographic dissection.The primary clinical endpoint was target vessel failure (tvf), defined as a composite of cardiac death, target vessel myocardial infarction (tvmi), and clinically driven-target vessel revascularization (tvr).Death was considered cardiac in origin unless obvious noncardiac causes could be identified.Tvmi was defined as myocardial infarction that could be related to the target vessel but not to another vessel.Tvr was defined as any repeat percutaneous intervention or coronary artery bypass graft (cabg) of any segment of the target vessel.Tvr was considered clinically driven if revascularization was performed in patients with ischemic signs confirmed using noninvasive tests or functional assessment, irrespective of the ischemic symptoms.Definite or probable stent thrombosis was defined according to the academic research consortium criteria.For the esdv patients with simultaneous lesions with dsdmax = 2.0 and >2.0 mm in different vessels, only events related to the vessel with dsdmax = 2.0 mm were counted.All patients were clinically followed up via clinic visits or telephone interviews.The acute procedural success rates were similar between the esdv and non-esdv groups (95.8% and 96.5%, respectively; p = 0.7).Angio graphically detectable distal edge dissection was observed in one (0.3%) patient in the esdv group and two (0.5%) patients in the non-esdv group and was successfully rescued by additional stenting in all cases.The median follow-up was 65.4 months in the esdv group and 64.5 months in the non-esdv group.The rate of complete follow-up was 94.1% and 96.5% in the esdv and the non-esdv groups, respectively.The tvf rates were 16.3% (50/307) and 12.1% (52/429) in the esdv and non-esdv groups, respectively.The rates of cardiac death, tvmi, and cdtvr in the esdv and non-esdv groups were 3.9% and 3.5%, 4.9% and 3.0%, and 12.7% and 9.1%, respectively.Probable or definite stent thrombosis was observed in three (1%) patients in the esdv group and one (0.2%) in the non-esdv group.After propensity score matching, 237 paired patients were well-matched in terms of baseline characteristics between the two groups.After matching, the tvf rate did not differ between the esdv and non-esdv groups along with cardiac death, all-cause mortality, tvmi, cdtvr, stroke, and stent thrombosis.There were no significant differences in the rates of tvf, cv death, tvmi, and cdtvr.

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 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: 18496745
• MDR Text Key: 332722723
• Report Number: 9612164-2024-00207
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 02/06/2024
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male