MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number UNK-CV-SR-ENDURANT

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

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Dyspnea (1816); Myocardial Infarction (1969); Pneumonia (2011); Renal Failure (2041); Distress (2329); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Medtronic received notification of a literature article entitled: "influence of anesthetic techniques on perioperative outcomes" yang liu, tiehao wang, jichun zhao limei kang, yukui ma, bin huang, ding yuan <(>&<)> yi yang doi:10.1016/j.Avsg.2020.11.034.If information is provided in the future, a supplemental report will be issued.

Event Description

Talent and endurant stent grafts were implanted in patients for endovascular aneurysm repair (evar) for infrarenal abdominal aortic aneurysm (aaa).The following malfunction was observed: unknown endoleak the following serious injuries wee observed: respiratory failure , cerebral hemorrhage, multiorgan failure, intraoperative extra procedures, cardiac complications, myocardial infraction, arrhythmia, acute heart failure, pulmonary complications, pneumonia, storke, delirium, renal complications, acute renal injury, renal failure, patient deaths were also reported, but as there is no causal link between patient deaths and the device the deaths will be made not reportable.

• Brand Name: ENDURANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 12311880
• MDR Text Key: 266153429
• Report Number: 9612164-2021-03102
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100021
• 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: 08/12/2021

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-ENDURANT
• Device Catalogue Number: UNK-CV-SR-ENDURANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/12/2021
• 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: 72 YR