MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA ANEURX AAADVANTAGE; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number AEXC262640

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Rupture (1546)

Patient Problems Abdominal Pain (1685); Rupture (2208)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An aneurx stent graft system was implanted in a patient for the endovascular treatment of a 70 mm diameter abdominal aortic aneurysm.It was reported that approximately 10.5 years post index procedure, the patient present emergently with abdominal pain.A ct scan was performed and indicated a ruptured aaa and a type ia endoleak.An intervention was performed on the same day with insertion of two endurant cuffs to seal the leak.The final angiogram revealed no leak and rupture containment.Per the physician, the cause of the event was due to device migration.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ANEURX AAADVANTAGE
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7761790
• MDR Text Key: 116391294
• Report Number: 2953200-2018-01148
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2008
• Device Model Number: AEXC262640
• Device Catalogue Number: AEXC262640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• Date Device Manufactured: 06/21/2006
• 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: 84 YR