MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number UNK-CV-SR-VALIANT

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

Patient Problems Aneurysm (1708); Stroke/CVA (1770); Infarction, Cerebral (1771); Fistula (1862); Hematoma (1884); Hemoptysis (1887); Hemorrhage, Cerebral (1889); Hemothorax (1896); Idioventricular Rhythm (1923); Unspecified Infection (1930); Ischemia (1942); Occlusion (1984); Pleural Effusion (2010); Pulmonary Insufficiency (2022); Renal Failure (2041); Rupture (2208); Perforation of Esophagus (2399); Respiratory Tract Infection (2420); Decreased Respiratory Rate (2485); Low Cardiac Output (2501); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from the journal article entitled; urgent endovascular treatment for non-traumatic descending thoracic aortic rupture rohit philip thomas, sandeep sunder amin, osama eldergash, tobias kowald, sebastian bremer, jerry easo, alexander weymann, malte book, marcin szczechowicz, bernhard schmuck and ajay chavan cardiovasc intervent radiol (2018) 41:1318¿1323, doi.Org/10.1007/s00270-018-2006-0.If information is provided in the future, a supplemental report will be issued.

Event Description

Valiant stent graft systems were implanted in patients for the endovascular treatment of non traumatic rupture of the descending thoracic aorta due to type b dissections or atherosclerotic aortic aneurysms.No additional clinical sequelae were reported and the cause of the events is unknown.It was reported that on an unknown date the following events were recorded: serious injury; infection, stroke, tracheostomy ,rupture aneurysm, aneurysm enlargement, false lumen rupture, hemodynamic instability/ hemodynamic shock, circulatory collapse, hemothorax, respiratory insufficiency, oesophageal perforation, pulmonary infection, cardiac instability, hematomas, left subclavian artery coverage, hemorrhagic pericardial effusion, hemorrhagic pleural effusion, hemoptysis secondary to aorto-bronchial fistula, pseudoaneurysm, infarction,.

• Brand Name: VALIANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7818442
• MDR Text Key: 118290254
• Report Number: 2953200-2018-01224
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VALIANT
• Device Catalogue Number: UNK-CV-SR-VALIANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/27/2018
• 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