MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
On (b)(6) 2013, the patient was implanted with a bifurcated, a suprarenal extension, and a limb stent graft.On (b)(6) 2015, the patient was implanted with additional bifurcated stent to treat a reported 3b endoleak.On (b)(6) 2016, the patient was implanted with additional suprarenal extension to treat a reported 1a endoleak.On (b)(6) 2018, endologix was made aware of endoleak (indeterminate origin).The physician plans to complete an angiogram to confirm the endoleak and determine treatment options.No further information is available at this time.There have been no additional patient sequelae reported.
Event or Problem Description
A secondary procedure was performed on (b)(6) 2018.The physician elected to implant an infrarenal stent graft extension below the renal arteries.An intraoperative type 1a endoleak was reported and a non - endologix (palmaz) stent was implanted to resolve this leak.It was reported that the patient had a non - endologix (viabahn) stent in the distal common iliac for a pseudo aneurysm repaired previously.The stent was undersized and the 17 fr sheath dislodged into the main body of the stent graft.The physician decided to place another non - endologix (palmaz) stent but was unsuccessfully.The physician convent to an open repair for the pseudo aneurysm.The physician bridged/bypassed the graft in the left iliac with an endologix limb extension.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of an indeterminate endoleak (proximal).Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms identified were; dislodgement of a non - endologix left iliac stent in between the main body and the aorta (foreign emboli), prolonged procedure (approximately 9 hours), iliac perforation with pseudoaneurysm and surgical repair of the left iliac artery.The final patient status was not reported.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7527925
• Report Number: 2031527-2018-00477
• Device Sequence Number: 1254350
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1315861-020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT # 1111621-002; LIMB STENT GRAFT, LOT # 1098516-037; SUPRARENAL EXTENSION, LOT # 1042706-011; SUPRARENAL EXTENSION, LOT # 1606289-005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR