MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA28-80/I16-40
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Stretched (1601)
Health Effect - Clinical Codes	Intimal Dissection (1333); Aneurysm (1708); Death (1802); Failure of Implant (1924); Thrombus (2101); Rupture (2208)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident devices have not been received for evaluation.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.To date no devices received.
Event or Problem Description
It was reported the patient had an initial implant with a bifurcated stent and a suprarenal aortic extension.The patient came in emergently with a ruptured aneurysm.The physician identified aneurysm sac growth and a potential type 3b or type 2 endoleak.It was reported the patient expired, the date is unknown.A secondary intervention was not reported and it is unknown if the patient underwent an additional procedure prior to passing away.
Additional Manufacturer Narrative
Additionally, there was evidence to reasonably support the following observations: coil/liquid embolism (right lateral portion near l4 lumbar), secondary endovascular procedure (non-endologix reline), thrombus (aorta/right iliac artery), dissection (right common femoral artery), endovascular procedure -second in the same day (three superficial femoral artery stents (non-endologix)) due to thrombus/dissection throughout right common femoral artery.Based on the information available the root cause of the reported event is unknown.Due to lack of medical information available for review, clinical evaluations was unable to find substantial evidence to confirm the following reported events: endoleak type iiib and ii, sac growth, and death.Clinical found evidence to reasonably suggest the following contributing factors to the reported event: dissection was caused by wire catheter manipulations.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.The manufacturing records confirm that the lots met all requirements prior to release.Device was not returned, therefore, sample evaluation was not completed.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6463698
• Report Number: 2031527-2017-00136
• Device Sequence Number: 16262412
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)170801
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1268326-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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: VELA SUPRARENAL- 1214305-020
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 81 YR