MAUDE Adverse Event Report: ENDOLOGIX LLC. ENDOLOGIX AFX; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Diminished Pulse Pressure (2606); Ruptured Aneurysm (4436)

Event Date 05/27/2022

Event Type  Injury  

Event Description

Endologix afx failure; the patient is s/p repair of aaa in 2012 using an endologix afx device.The patient presented to the ed with acute abdominal pain and ct scan demonstrating ruptured aneurysm and type iii endoleak.He was taken emergently to the operating room and was repaired with a medtronic graft.During the course he had pea arrest intra-op which responded to resuscitation.The patient was transferred to the icu intubated postoperatively and was able to be extubated the same day.He required supplemental oxygen until postoperative day 4.He was discharged to home postoperative day 5.Fda safety report id# (b)(4).

• Brand Name: ENDOLOGIX AFX
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): ENDOLOGIX LLC.
• MDR Report Key: 14622308
• MDR Text Key: 293550153
• Report Number: MW5110135
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC GRAFT
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic