MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Malposition of Device (2616)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Pain (1994)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
Patient was initially implanted with an afx bifurcated, one vela suprarenal, and two vela infrarenal.Endologix became aware of a case from a tweet by the physician that performed the secondary case.It was reported that the physician noted that it was not a faulty grafts, but the implanting physician misplaced the device by not covering more of the right common iliac.The patient presented emergently with abdominal pain.Patient reported to be doing well post procedure and is scheduled for a one month follow up.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7468265
• Report Number: 2031527-2018-00388
• Device Sequence Number: 113424
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/04/2018

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: Physician
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1331258017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/27/2018
• 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: VELA INFRARENAL-LOT: 1252181010; VELA INFRARENAL-LOT: 12525630012; VELA SUPRARENAL-LOT: 1336512024
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR