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 Stroke/CVA (1770); Myocardial Infarction (1969); Perforation (2001); Cardiac Tamponade (2226); Vascular Dissection (3160); Heart Block (4444); Insufficient Information (4580)

Event Date 10/23/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled "clinical outcomes of biodegradable versus durable polymer drug eluting stents in rotational atherectomy: results from rock registry".The aim of this study was to compare the clinical outcomes of biodegradable polymer (bp) versus durable polymer (dp) drug eluting stents (des) in patients with calcified coronary lesions who underwent rotational atherectomy (ra) and percutaneous coronary intervention (pci).This study was based on the rotational atherectomy in calcified lesions in korea (rock) registry.540 patients who underwent pci using ra due to calcified cad between january 2010 and october 2019 were retrospectively enrolled and analyzed.For this study 30 patients were excluded from the analysis due to the use of bare metal stent (bms), first generation des and drug eluting balloons.The remaining 510 patients were divided into two groups according to the durability of the des polymer used during the procedure.From this registry, 272 patients with pci using dp-des and 238 patients with bp-des were selected for analysis.Medtronic resolute onyx (n=61) and endeavor des (n=32) were amongst the stents used in the dp-des group along with several brands of non-medtronic des.The bp-des group used non-medtronic des only.Lesions treated included the left anterior descending artery (lad), left circumflex artery (lcx) and the right coronary artery (rca).The primary clinical outcome of this study was all-cause death during 3 years of follow-up.The secondary outcomes were 3-year cardiovascular death, and target-lesion failure (tlf); defined as a composite of cardiac death (cd), target-vessel spontaneous myocardial infarction (tvmi), or ischemia-driven target-lesion revascularization (tlr).Technical success was defined as residual stenosis of less than 30% in the presence of grade iii thrombolysis in myocardial infarction (timi) flow.Procedural success was defined as technical success without in-hospital major adverse cerebral and cardiac events including in-hospital death, in-hospital cerebrovascular accident (cva), urgent revascularization (pci or surgery) following the index procedure, procedure-related atrioventricular block requiring temporary pacemaker insertion, type d-f coronary perforation or dissection, intervention (including surgery) due to cardiac tamponade, and peri-procedure mi.Procedural success rates were 97.4% and 97.5% for dp-des and bp-des, respectively.In the dp-des group 29 (10.7%) deaths occurred, and in the bp-des group 11 (4.7%) deaths occurred.Cardiovascular death was reported in 22 (8.1%) patients in the dp-des group and 8 (3.4%) patients in the bp-des group.After adjusting for baseline variables using propensity score matching, pci with bp-des was associated with a significant decrease for the primary outcome of all-cause death.Bp-des was also associated with a lower risk of cardiovascular death, but there was no difference in tlf.Tlf occurred in 37 (13.6%) of the dp-des group and 29 (12.2%) of the bp-des group.

Manufacturer Narrative

Title: clinical outcomes of biodegradable versus durable polymer drug eluting stents in rotational atherectomy: results from rock registry.Authors: kyung an kim, sung-ho her, kyusup lee, ik jun choi, jae-hwan lee, jang hoon lee, sang rok lee, pil hyung lee, seung-whan lee, ki dong yoo, su nam lee, won young jang, donggyu moon, keon-woong moon, kyeong ho yun, and hyun-jong lee journal name: journal of clinical medicine year: 2022 reference: https://doi.Org/ 10.3390/jcm11216251 pmid: 36362476.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

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 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: 18500873
• MDR Text Key: 332724194
• Report Number: 9612164-2024-00212
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P160043
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 02/07/2024
• 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: 74 YR
• Patient Sex: Male