MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-80/I16-40

Device Problems Collapse (1099); Hole In Material (1293); Leak/Splash (1354); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915)

Patient Problems Aneurysm (1708); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Renal Failure (2041); Shock (2072); Rupture (2208)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

To date, the incident device has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted to treat a small abdominal aortic aneurysm with aortic iliac occlusive disease (aiod).In addition to the bifurcated stent, the physician implanted two kissing stents in the right and left common iliac arteries.The patient is reported to have calcification in the aortic neck.The physician performed post dilation of the implanted devices by use of aggressive ballooning and a final angiogram revealed a ruptured aorta and a possible type 3b endoleak of the main body device.The physician implanted a second bifurcated stent to resolve the issue.The procedure was completed and the patient was reported to be in stable condition.The patient was sent to the intensive care unit (icu) where they later expired.The cause of death was not reported to endologix.

Manufacturer Narrative

(b)(4).Clinical review found evidence to reasonably suggest the following factors contributed to the reported event: off-label usage, pre-existing endoleak type ia at implant, pre-existing aortic dissection, increase in the infrarenal aortic angulation, and increased angulation of the left iliac limb at the bifurcation.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned, therefore no physical evaluation was completed.

Manufacturer Narrative

The devices remain implanted in the patient and was not returned for device evaluation.Based on the information received, clinical evaluation confirmed the reported type 3b endoleak, rupture and patient death.Clinical evaluation refuted the reported cardiac-related death, determining the death was caused by the intra-operative rupture; hemorrhage and shock.The most likely cause of compromised stent graft integrity could not be determined due to the lack of available medical images surrounding the implant procedure.However, procedure-related ballooning in an off-label, calcified iliac anatomy likely contributed to this device failure (intentional user error).The extra angioplasty required to treat the first main body stent likely contributed to the intra-operative negative sequalae (procedure-related issue).Notably, the off-label use of non endologix products and the pre-existing iliac tortuosity and calcification (cautionary product use conditions) might also have contributed to this event.Associated clinical harms for this device failure included: type iiib endoleak of the first main body stent; intra-operative rupture; hemorrhage; hemodynamic instability (shock), death on the operative day.No procedure-related harms were detected due to the persistent of intra-operative instability.The lot usage history shows that no other units from the affected lot has been involved in any similar complaints at this time.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6689325
• MDR Text Key: 87153458
• Report Number: 2031527-2017-00486
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)180607
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2018
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 1701103-008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 08/25/2017; 08/25/2017
• Supplement Dates FDA Received: 07/06/2017; 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX2 BIFURCATED STENT GRAFT LOT - 1668623020
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Weight: 77