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

Catalog Number RSINT40026X

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Hematoma (1884); Hemorrhage/Bleeding (1888); Shock (2072)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: a case of acute myocardial infarction due to coronary artery compression by mediastinal hematoma associated with thoracic aortic aneurysm rupture authors: yu hoshika, junsuke shibuya, hiroyuki nakano, eitaro kodani, wataru shimizu journal: journal of cardiology cases year: 2022 reference: doi.Org/10.1016/j.Jccase.2021.09.002.If information is provided in the future, a supplemental report will be issued.

Event Description

A case study was submitted for review titled: a case of acute myocardial infarction due to coronary artery compression by mediastinal hematoma associated with thoracic aortic aneurysm rupture.The patient had a chronic aortic dissection and underwent follow up using chest radiography every year and contrast-enhanced computed tomography (ce-ct) every 3 years.The latest ce-ct showed the diameter of the descending aorta and thickness of the false lumen had remained unchanged from the previous follow-up.The patient presented with pneumonia.The patient was initially treated with mechanical ventilation and intravenous antibiotic injections after which the patient's condition improved.The patient was extubated on the 10th day of hospitalization.However, 5 days later, the patient complained of chest and back pain and went into shock with a blood pressure of 88/40 mmhg.Electrocardiogram showed st-segment elevation in the inferior leads and an acute inferior myocardial infarction (mi) was suspected.Coronary angiography revealed subtotal occlusion of the right coronary artery (rca) ostium and intravascular ultrasound showed flattening of the rca ostium without plaque rupture which indicated no typical acute coronary syndrome.A percutaneous coronary intervention (pci) using a 4.0 x 26mm resolute zotarolimus-eluting stent was performed at the site of the occlusion to facilitate recovery from shock.Stent dilatation remained insufficient in some portions but coronary flow recovered to thrombolysis in myocardial infarction grade 3 and hemodynamics transiently improved immediately after pci.Routine dual antiplatelet therapy (dapt) was initiated to prevent acute stent thrombosis.The patient's back pain relapsed with incomplete recovery from shock.A ce-ct was performed to determine the cause of the prolonged shock state, which revealed a massive posterior mediastinal hematoma and a thoracic aortic aneurysm (taa) rupture with no changes in the diameter of the descending aorta.No pulmonary embolism or cardiac rupture was observed.It was then determined that the patient¿s acute mi was caused by compression of the rca ostium by a massive mediastinal hematoma and the prolonged shock state was caused by massive hemorrhage associated with taa rupture.The patient was urgently transferred to another hospital to undergo open surgical repair of the ruptured descending aorta using a non mdt artificial graft replacement.The patient survived.

Manufacturer Narrative

Additional information: procedural images in the article provided the basis of the analysis.The images provided confirm the reported stent malpposition 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: 14191922
• MDR Text Key: 289949464
• Report Number: 9612164-2022-01561
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSINT40026X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female