MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-110/I20-30
Medical Device Problem Codes	Partial Blockage (1065); Material Puncture/Hole (1504); Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Death (1802); Rupture (2208); Stenosis (2263)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
Endologix became aware of a narrowing at distal right common iliac on (b)(6) 2018 as reported by physician (b)(6) at (b)(6).The reported stenosis was discovered during a follow-up ultrasound on an unknown date.Physician states the stenosis is at the end of the stent graft which was landed right at the hypogastric take off.The patient was originally implanted with an afx2 bifurcated stent graft, one (1) afx vela infrarenal, three (3) vela suprarenals, and four (4) ovation ix extenders on (b)(6) 2018 by the reporting physician.The patient is in stable condition.Physician decided to not do a re-intervention, and will only anticoagulate the patient and monitor.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported rupture and patient expiration on (b)(6) 2019, but the right-side common iliac stenosis was unconfirmed.The death was most likely procedure-related due to the patient's pre-operative and post-operative rupture, which developed into abnormal bleeding, respiratory failure, and cardiopulmonary resuscitation; patient left the operating room post-secondary endovascular procedure with non-endologix products and in stable condition.The clinical assessment also determined that there was evidence to reasonably suggest that a persistent proximal and distal type iiib endoleaks occurred, and that the index procedure was off-label due to right iliac measured 26mm and left iliac 40.6mm (iliac diameter should be 10-23mm) with use of concomitant non-endologix products.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device iteration is afx2.Correction: concomitant medical products; remove 1762500-004.Device code; remove 1065.Method code; remove 3263, 3323.Result code; remove 3221.Conclusion code; remove 92.
Event or Problem Description
Additional information received confirming that the patient experienced a ruptured aortic aneurysm during the weekend of (b)(6) 2019 and was repaired by another surgeon from a cardiothoracic group in (b)(6).The patient later expired on (b)(6) 2019 while in the hospital and after the re-intervention was completed.In addition, clinical assessment determined that the initial implant procedure was off-label, due to anatomy outside ifu requirements and use with non-endologix products, and that persistent type iiib endoleaks were also present.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7663638
• Report Number: 3008011247-2018-00152
• Device Sequence Number: 13892883
• Product Code: MIH
• UDI-Device Identifier: M701TVEX282845J1
• UDI-Public: +M701TVEX282845J1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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 Expiration Date: 11/27/2018
• Device Model Number: BEA25-110/I20-30
• Device Catalogue Number: TV-EX282845-J
• Device Lot Number: 1762500-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA INFRARENAL-LOT 1738155-016; AFX-VELA SUPRARENAL-LOT 1750999-014; AFX-VELA SUPRARENAL-LOT 1754744-003; AFX-VELA SUPRARENAL-LOT 1754744-005; AFX2-AFX2 BIFURCATED STENT GRAFT-LOT 1762500-004; OVATION IX EXTENDER: FS092017-15; OVATION IX-EXTENDER-LOT FS032017-46; OVATION IX-EXTENDER-LOT FS071317-19; OVATION IX-EXTENDER-LOT FS121216-12; AFX-VELA INFRARENAL-LOT 1738155-016; AFX-VELA SUPRARENAL-LOT 1750999-014; AFX-VELA SUPRARENAL-LOT 1754744-003; AFX-VELA SUPRARENAL-LOT 1754744-005; AFX2-AFX2 BIFURCATED STENT GRAFT-LOT 1762500-004; OVATION IX-EXTENDER-LOT FS032017-46; OVATION IX-EXTENDER-LOT FS071317-19; OVATION IX-EXTENDER-LOT FS121216-12
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Age: 81 YR