MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I16-40
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Stenosis (2263); Claudication (2550)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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
It was reported that during an initial procedure to implant an afx 2 bifurcated device to treat a small aneurysm and occlusive disease, an intra-operative endoleak type iiib was identified.It was decided to reline the main body with an additional main body to resolve the endoleak.The patient condition is reported as stable and the patient will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; intraoperative endoleak type iiib, and successful reline.Additionally there was evidence to reasonably support the following observations; bilateral surgical repair (bovine patch and endarterectomy) of both access sites, multiple right thrombo-emboli, occlusion of the superficial femoral artery, surgical bypass (right side common femoral artery to superficial femoral artery [vein bypass graft]), additional diagnostic angiogram for post procedure claudication/diminished pulses (proximal stenosis in respect to the bypass graft).The event device was returned for further evaluation.The most likely cause of the compromised stent graft integrity was the off-label aortic and iliac anatomy, and the cautionary product use condition of access site occlusive disease (intentional user error) in combination with an intraoperative angioplasty within a calcified iliac/bifurcation (procedure-related issue and unintentional user error).Procedure-related harms included: prolonged procedure; surgical repair of both femoral arteries; surgical bypass with the saphenous vein [common femoral to superficial femoral artery]; two endovascular thrombectomies of the bypass graft; and, multiple right-sided emboli; and, stenosis of the right lower extremity (with claudication).It was unlikely that the endoleak or the relining contributed to the procedure-related harms, rather, pre-existing disease likely caused these unexpected outcomes, which also included a repeat angiogram on the first post-operative day due to complaints of numbness/tingling.The patient was discharged from the hospital on the seventh post-operative day, but their condition could not be ascertained.It was reported that the patient was in a favorable condition post implant; there have been no reports of further negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Correction: (b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6781848
• Report Number: 2031527-2017-00407
• Device Sequence Number: 2066295
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)180322
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: Physician
• Device Expiration Date: 03/22/2018
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 1669372-011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR