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

Model Number BA25-110/I16-30

Device Problems Failure To Adhere Or Bond (1031); Use of Device Problem (1670); Difficult to Advance (2920)

Patient Problems Death (1802); Electro-Mechanical Dissociation (1826); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917); Renal Failure (2041); Test Result (2695)

Event Date 06/06/2015

Event Type  Death  

Manufacturer Narrative

Based upon the clinical evaluation, at implant, there was evidence to support the difficult access and the need to place a non-endologix stent within the external iliac in order to complete the deployment of the main body and suprarenal cuff.There was also evidence of a persistent type ia endoleak on the last cine run.The reported secondary procedure of a right femoral repair due to a groin hematoma, the ensuing renal failure, respiratory difficulty and death could not be established due to lack of information.A manufacturing record review was performed, the lot met all release criteria with no related 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 findings, an root cause could not be determined based upon the available information.However, product use was incongruent with the ifu due to: the immediate anterior angulation of the aortic neck with the length of 7 mm; the left common iliac artery angulation of 120 °; and, bilateral iliac artery focal stenosis of 8-9 mm.Cautionary product use conditions that might have contributed to this event included: the severe calcifications at the aortic neck and iliac arteries; and, the inability to tolerate contrasted surveillance.The pre implant imaging was non contrast, and the submitted angiogram utilized minimal contrasted imaging.Addition device: model number: a28-28/c95-o20v, lot: 1252407-015, release date: 2/17/2015, expiration date: 1/30/2018.Devices not returned to manufacturer.

Event Description

It was reported that during the initial procedure on (b)(6) 2015, physician was unable to advance sheath due to anatomy.Ended up putting viabahn (gore) device, which they were able to advance through, then proceeded with evar.Used pre-closed technique which had bleeding at access site on closure due to heparin.Patient had hematoma right side and surgical repair of the femoral tissue.Procedure successful.Reportedly, post event, patient had breathing trouble and had renal insufficiency, creatinine high, contrast used during procedure, devices below renals.Patient became deceased on (b)(6) 2015 due to hemorrhagic shock.

• Brand Name: AFX
• Type of Device: BIFURCATED
• 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: 5069697
• MDR Text Key: 25478083
• Report Number: 2031527-2015-00357
• 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
• Report Date: 06/08/2015

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: 02/18/2018
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1252354-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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): Death
• Patient Age: 76 YR