MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	IS20-25/C65 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.The secondary procedure performed on (b)(6) 2018 has been reported to the fda under mfr# 2031527-2018-00480.
Event or Problem Description
Primary procedure performed on (b)(6) 2009, by dr.(b)(6).A intuitrak bifurcated stent graft and a intuitrak infrarenal aortic extension.Secondary procedure was performed on (b)(6) 2018, by dr.(b)(6), to treat progression of left common iliac aneurysmal disease beyond original limb placement.An ovation ix extender was placed and two afx limb extensions were bridged in the right iliac, at the time of procedure there was minimal overlap noted between the extension in the right iliac.Follow-up computerized tomography scan performed on (b)(6) 2018, showed a endoleak 3a in the right limb extending through the common iliac aneurysm.Patient was reported to be asymptomatic, but the right common iliac artery aneurysm has enlarged to 5.9cm's.(b)(6) 2018, patient inr was high at 2.0.Tertiary was performed on (b)(6) 2018, by dr.(b)(6).A ovation extender and a ovation iliac limb were implanted.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the information received, clinical assessment confirmed the reported type iiia endoleak of the right common iliac artery.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.A definitive root cause was unable to be determined for the reported event; however, the off label iliac anatomy at the index procedure - right common iliac diameter of 49mm with thrombus in the landing zone likely contributed to this event.The devices remain implanted in the patient; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7572641
• Report Number: 2031527-2018-00520
• Device Sequence Number: 1529922
• Product Code: MIH
• UDI-Device Identifier: 00818009011473
• UDI-Public: (01)00818009011473(17)210118
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/16/2018

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: 01/18/2021
• Device Model Number: IS20-25/C65 SA
• Device Lot Number: 1777214001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 03/06/2019
• 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-0009-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT (LN 1618783009); INTUITRAK BIF STENT GRAFT (LN W09-1582-029); INTUITRAK INFRARENAL AORTIC EXT (LN W07-1676); OVATION IX EXTENDER (LN FS071017-33); AFX LIMB STENT GRAFT (LN 1618783009); INTUITRAK BIF STENT GRAFT (LN W09-1582-029); INTUITRAK INFRARENAL AORTIC EXT (LN W07-1676); OVATION IX EXTENDER (LN FS071017-33)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR