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

Model Number 25-16-140BL

Device Problems Bent (1059); Fracture (1260); Hole In Material (1293); Leak/Splash (1354)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2015

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted.

Event Description

The patient had a bifurcated and limb extension implanted on (b)(6) 2010.Reportedly, a aneurysm expansion was confirmed and a computed tomography was done on (b)(6) 2015 and a endoleak 3b was displayed due to a stent fracture of the bifurcated device's framework.The patient elected to perform a fluoroscopy on (b)(6) 2015 and confirmed two stent fractures at the framework's bent section of the bifurcated device.Then, angiography was performed and an endoleak 3b was confirmed and a type 2.The physician elected to treat the patient with endurant leg at the main body of bifurcated device against the endoleak 3b and it resolved.Furthermore, the physician suspected an inadequate sealing at distal area of the limb.Ultimately, the physician performed a coil embolization to left internal iliac artery and placed and endurant leg from left common iliac artery to left external iliac artery for preventive of a suspected proximal endoleak.The type 2 endoleak remains and the physician decided to continue with a follow-up observation for the patient.

Manufacturer Narrative

Based upon the clinical assessment, only the reported type iiib endoleak was confirmed.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.A design or manufacturing root cause for the reported event is inconclusive based on the investigation.The clinical review identified that severe infrarenal aortic angulation of greater than 100° might have contributed to the type iiib endoleak.

• Brand Name: INTUITRAK
• 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: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5275406
• MDR Text Key: 32991229
• Report Number: 2031527-2015-00488
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Initial,Followup
• Report Date: 11/15/2015

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 Model Number: 25-16-140BL
• Device Lot Number: W09-3445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2010
• 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: 81 YR