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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Title: clinical implications of poststent optical coherence tomographic findings severe malposition and cardiac events authors: byung gyu kim, md, mateusz kachel, jung-sun kim, giulio guagliumi et al.Journal: jacc: cardiovascular imaging issue: 1 ref: https://doi.Org/10.1016/j.Jcmg.2021.03.008.Average age, majority gender, 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 death(s) was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled: clinical implications of poststent optical coherence tomographic findings: severe malposition and cardiac events.The aim of the study was to evaluate the impact of poststent optical coherence tomography (oct) findings including severe malposition on long-term clinical outcomes.A total of 1,290 patients with 1,348 lesions who underwent oct immediately post stenting were eligible for this study and were enrol led.Lesions treated included the left main, left anterior descending artery, left circumflex artery, right coronary artery and ramus intermedius.Lesions had a mean stenosis of 66%.Patients received drug-eluting stents (des) including sirolimus-eluting stents, paclitaxel-eluting stents, zotarolimus eluting stents, everolimus eluting stents or biolimus a9-eluting stents.Medtronic endeavour rx stents and resolute integrity stents were the zotarolimus eluting stents used during this study.Each des was implanted according to current standard techniques and pre-dilation, post-stent dilation, application of mechanical support or concomitant medication, were performed at the discretion of the operator.Post-stent oct findings included stent edge dissection, stent malposition, malposed struts, tissue protrusion/prolapse, thrombus and stent under expansion.Follow up oct was performed at 3, 6, or 12 months after the initial angioplasty.Cardiac deaths, definite, probable and possible stent thromboses, stent occlusion, target vessel-related mi and target lesion revascularization (tlr).

Manufacturer Narrative

Additional information: annex d code added 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: 14141491
• MDR Text Key: 289515888
• Report Number: 9612164-2022-01507
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• 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 Age: 61 YR
• Patient Sex: Male