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

Model Number UNK-CV-SR-ANEURX

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

Patient Problems Abdominal Pain (1685); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Unspecified Infection (1930); Myocardial Infarction (1969); Occlusion (1984); Pain (1994); Sepsis (2067); Thrombus (2101); Rupture (2208); Multiple Organ Failure (3261)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant, talent and anuerx stent grafts were implanted in patients for endovascular aneurysm repair.The patients required late open conversion.The following events were reported: serious injury- rupture, infection, abdominal pain, back pain, sepsis, haemorrhagic shock, thrombosis, explant, aortoenteric fistula, intervention for endoleaks, occlusion, thrombus, mi, multiple organ failure, hypotension, renal failure, ischemia, pseudoaneurysm.

• Brand Name: ANEURX
• 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: 8389595
• MDR Text Key: 137796505
• Report Number: 2953200-2019-00315
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P990020
• 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: 03/05/2019

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-ANEURX
• Device Catalogue Number: UNK-CV-SR-ANEURX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/05/2019
• 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: 76 YR