MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Rupture (2208)
Date of Event	03/01/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.Device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 4.5 years post initial procedure, the patient presented emergently with a ruptured aaa to the emergency room (er).A type 3a endoleak with sac growth was identified.The physician elected to perform an open repair and the devices were explanted.The patient was reported to not be in good health post intervention and expired due to post surgery complications.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type iiia endoleak was unconfirmed due to a lack of relevant medical imaging.The reported rupture, surgical conversion and patient death events were confirmed.Although unconfirmed, the index case was reported to be off label (short neck length of 10mm - should be equal to or greater than 15mm), neck taper was 18.8% (should be less than 10%) with a borderline distal neck measurement of 31.9mm (should be 18-32mm) could have contributed to a type iiia endoleak.Definitive device and user relatedness for the sac growth and rupture could not be determined.The procedure related harms identified were acute renal failure, respiratory failure, hemodynamic instability and abnormal blood loss.The patient death was determined to be device related.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned by the hospital post explant; therefore, no device evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.B1 adverse event/product problem - updated; e1: name and address - email updated; h6: result code ¿ remove 3233; h6: conclusion code ¿ remove 11; h10: additional manufacture narrative: updated h3 other text : device not returned after explant.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9924059
• Report Number: 2031527-2020-00127
• Device Sequence Number: 14299772
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)180408
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 04/08/2018
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1320915-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT 1280872019.; VELA SUPRARENAL, LOT 1280872019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR