MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; INFRARENAL EXTENSION

Model Number	A25-25/C75
Medical Device Problem Codes	Occlusion Within Device (1423); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Thrombosis (2100); Claudication (2550)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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
On (b)(6) 2018, the patient was implanted with a bifurcated stent, an infrarenal extension and a non-endologix stent.On (b)(6) 2018, the patient had a routine 1-month follow up.The patient complained of claudication of the buttock.A follow up ct image was performed.The infrarenal extension was discovered to be buckled (in-folded) and the extension inner-lumen was occluded by thrombosis.It was noted that the bifurcated stent and non- endologix stent were not deformed or occluded.On (b)(6) 2018, the physician expanded the deformed infrarenal extension by ballooning.The physician elected to implant two (2) non- endologix stents and limb extension to resolve this event.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported event of cuff in-folding (buckling) and occlusion with the infra-renal cuff.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.Off label use due to a non- endologix stent (gore stent graft) used at time of implant.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: INFRARENAL EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7386065
• Report Number: 2031527-2018-00208
• Device Sequence Number: 16424395
• Product Code: MIH
• UDI-Device Identifier: 00818009010285
• UDI-Public: (01)00818009010285(17)200425
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2018

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: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: A25-25/C75
• Device Lot Number: 1679659-018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2018
• Supplement Date Received by Manufacturer: 03/04/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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: BIFURCATED STENT, LOT # 1750685-017; BIFURCATED STENT, LOT # 1750685-017
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR