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

Model Number RSINT25018X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cyanosis (1798); Myocardial Infarction (1969); Loss of consciousness (2418); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 06/07/2023

Event Type  Injury  

Event Description

During a planned surgical intervention four resolute integrity rx coronary drug eluting stents were implanted to treat a non-calcified lesion with 50-60% stenosis in the right coronary artery rca.Negative prep was not preformed on the devices.The lesion was pre-dilated.The devices did not pass through a previously deployed stent.Excessive force was not used during delivery of the devices.It was reported two hours post stent implantation a clinical adverse event occurred.It was detailed that the patient suffered an acute stent thrombosis and myocardial infarction.The patient developed loss of consciousness, cyanosis of the face and neck, lack of breathing and pulse on the electrocardiogram (ecg).Resuscitation measures were initiated including; indirect heart massage of 120 compressions per minute, breathing with an ambu bag, intravenous adrenaline 1ml given every 5 minutes and defibrillation with biphasic current of 200j.A short-term of the sinus rhythm was recovered after defibrillation.300mg of cordarone (amiodarone hydrochloride) was given in a jet.It was detailed that there were signs of myocardial damage noted on the ecg after the sinus rhythm was restored.The patient was intubated and taken to x-ray where coronary artery angiography (cag) was performed.On the angiogram it was noted that there was right type of myocardial blood supply.The contours of the arteries were uneven.The contrast was homogeneous.The left coronary artery (lca) trunk was without hemodynamically significant changes.Permanent residence stenosis of the proximal third up to 50-60% without hemodynamically significant changes.The dv was without hemodynamically significant changes.The oa was without hemodynamically significant changes and the mv was without hemodynamically significant changes.A thrombotic occlusion in the stent was found from the middle third of the pka with collateral filling of the post-occlusive bed from the lka basin.Mechanical recanalization, thrombus aspiration and balloon angioplasty of the rca was performed.The patient was discharged 12 days later in a satisfactory condition.No further patient injury was reported.                             .

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.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

Image analysis: there movie images were provided from the account.The first image shows jacket of stent from the proximal to the distal rca.Contrast injection into the proximal vessel is confirmed but due to the presence of the reported thrombus there is no flow through the newly deployed stents.The second image shows contrast injection into left coronary system.Proximal to mid lesion evident in the vessel that has not been stented.The third image shows a fully occluded rca.No other images were provided to identify the root cause of the thrombus.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.

Event Description

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Manufacturer Narrative

Image analysis: one photo with four device stickers of resolute integrity.Rsint25018x, lot number 0011558066 matches what was reported by the account for pli-10.No image of device received for review.Additional information: all 4 stents were implanted into the rca.No problems were noted during the the deployment of the stents and they were fully expanded.All 4 stents in the rca were thrombosed.The diagonal branch of the left coronary artery (dv) was without hemodynamically significant changes.The envelope artery (oa) was w ithout hemodynamically significant changes and the marginal branch (mv) was without hemodynamically significant changes.A thrombotic occlusion in the stent was found from the middle third of the right coronary artery (pka) with collateral filling of the post-occl usive bed from the left coronary artery (lka) basin.The infarction was treated by restoring blood flow through the infarct-related artery and conventional drug therapy.It was believed that the heart attack that developed after the operation was associated with the stent thrombosis.The patients condition is reported to be satisfactory.Correction: img 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.

Manufacturer Narrative

Additional information: ventricular fibrillation was on the ecg.The patient was on dual antiplatelet therapy (dapt) when the event occurred.Initial reporter name and phone number 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

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: 17353718
• MDR Text Key: 319345598
• Report Number: 9612164-2023-03289
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RSINT25018X
• Device Catalogue Number: RSINT25018X
• Device Lot Number: 0011558066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Date Device Manufactured: 12/19/2022
• 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; Other
• Patient Age: 72 YR
• Patient Sex: Male