MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED DEVICE

Model Number BA22-80/I20-40

Device Problems Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Test Result (2695)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.Device remains implanted.

Event Description

It was reported the patient had a procedure on (b)(6) 2013 with a bifurcated device, and a suprarenal aortic extension.Reportedly, during a routine follow up a computed tomography scan revealed a type 3b endoleak.The physician elected to treat the patient with a bifurcated device, and endoleak resolved.The patient is in stable condition.

Manufacturer Narrative

Based upon the clinical assessment, the reported type iiib endoleak was not confirmed although a secondary procedure was confirmed to reline the original implant.A type 11 endoleak was identified.A manufacturing record review was performed, the lot met all release criteria with no issues or deviations that would explain the reported event.The lot usage history showed all units have been consumed and no other units from this lot were involved in any similar event.The product labeling was reviewed and confirmed that the reported event is adequately captured in the existing labeling.Based upon the investigation, a root cause was not definitely identified.The clinical review identified the following factors that may have contributed to the patient outcome: multiple patent lumbar and inferior mesenteric arteries; patient antiplatelet therapy (asa).Due to the lack of medical imaging, it is unk if the absence of renal blood flow was related to stent migration or some other factor.There was evidence to support an additional main body relining from an internal product forms.Multiple additional endovascular procedures and the placement of a non-endologix stent within the left common iliac artery at implant might also have challenged the integrity of the bifurcated stent.Although a design or manufacturing root cause identification was inconclusive.

• Brand Name: AFX
• Type of Device: BIFURCATED DEVICE
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 9495984772
• MDR Report Key: 5030406
• MDR Text Key: 24047986
• Report Number: 2031527-2015-00332
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/28/2015

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: Physician
• Device Expiration Date: 01/31/2014
• Device Model Number: BA22-80/I20-40
• Device Lot Number: 1091218-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2013
• 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: 87 YR