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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

An erp (investigator-initiated study) was submitted for review titled 'safe-stemi for seniors.Ide progress report and investigator listing'.This was a multicenter, randomized, open-label, unblinded, active and historical-controlled trial, which aimed to simultaneously address four potential advances in st segment elevation myocardial infarction (stemi) care for patients at least 60 years old.This included examining the effectiveness of zotarolimus-eluting stents for radial primary percutaneous coronary intervention (pci) in stemi, and to evaluate the safety and benefit of instantaneous wave-free ratio (ifr) complete revascularization vs.Infarct artery only revascularization in primary pci of patients with multi-vessel coronary artery disease (cad).Other study objectives included obtaining data on the real-world application of radial access for primary pci in the public health focus on an elderly population, and to evaluate the safety of the non-medtronic introducer and tr band on an elderly population.During one case a patient initially presented with a st segment elevation myocardial infarction (stemi) and a medtronic resolute stent was implanted to the proximal left anterior descending (lad) artery.It was reported that the patient suffered a device-related serious adverse event within a single vessel.About two hours post procedure the patient complaint of chest discomfort which continued to worsen.An electrocardiogram (ekg) was done showing anterior myocardial infarction (mi).The patient was taken back to the cath lab where it was noted that the lad stent was occluded due to an exit dissection, and the stent was under-deployed.A successful intravascular ultrasound (ivus) guided transluminal coronary angioplasty (tca) was performed at the distal extent of the initial lad stent, with exit dissection and extensive stenting of the mid lad.There was loss of apical lad.Two 3.5x16mm and 3.0x32mm non-medtronic stents were implanted.The dissection was definitely related to the medtronic stent.The dissection resolved with sequelae.

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: 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: 18657497
• MDR Text Key: 334723604
• Report Number: 9612164-2024-00620
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• 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: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2024
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male