MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event has not be returned for evaluation.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.
Event or Problem Description
During the re-intervention of a previously reported event (2031527-2020-00038) for a type 3a endoleak, the physician dislodged the previously implanted afx limb stent graft extension.The physician elected to treat the previously reported event by relining the originally implanted devices with an afx2 bifurcated stent graft device and a medtronic (non-endologix) 40mm thoracic graft in the aorta (off-label secondary procedure due to noncompatible use with a non-endologix device).The physician experienced difficulty removing the medtronic (non-endologix) delivery system and while doing so, the top cap of the medtronic (non-endologix) delivery system dislodged the afx limb stent graft extension.The dislodged limb extension subsequently occluded the common femoral artery.The patient was transferred to another hospital be treated by another physician.The other physician elected to explant the dislodged limb extension.Then implanted another afx limb stent graft extension and an ovation ix extender device to resolve the right iliac occlusion.The other physician also implanted a gore (non-endologix) 13mm viahban stent to repair the damaged external iliac artery (off-label tertiary procedure due to noncompatible use of afx with ovation and non-endologix devices).
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it was discarded by the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the right iliac limb dislodgement with resultant occlusion.This is consistent with the reported adverse event/incident.The most likely causation for the dislodgement with resultant occlusion was most likely user related due to the use of non endologix concomitant products (off label).The final patient status remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.Corrections: e1: initial reporter/name and address - updated h6: result code ¿ remove 3233 h6: conclusion code ¿ remove 11.
Event or Problem Description
During the re-intervention of a previously reported event (2031527-2020-00038) for a type 3a endoleak, the physician dislodged the previously implanted afx limb stent graft extension.The physician elected to treat the previously reported event by relining the originally implanted devices with an afx2 bifurcated stent graft device and a medtronic (non-endologix) 40mm thoracic graft in the aorta (off-label secondary procedure due to noncompatible use with a non-endologix device).The physician experienced difficulty removing the medtronic (non-endologix) delivery system and while doing so, the top cap of the medtronic (non-endologix) delivery system dislodged the afx limb stent graft extension.The dislodged limb extension subsequently occluded the common femoral artery.The patient was transferred to another hospital be treated by another physician.The other physician elected to explant the dislodged limb extension.Then implanted another afx limb stent graft extension and an ovation ix extender device to resolve the right iliac occlusion.The other physician also implanted a gore (non-endologix) 13mm viahban stent to repair the damaged external iliac artery (off-label tertiary procedure due to noncompatible use of afx with ovation and non-endologix devices).Updated information: the physician explanted the previously implanted medtronic (non-endologix) 40mm thoracic graft and not the endologix stent graft therefore no device was returned to endologix.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9735123
• Report Number: 2031527-2020-00055
• Device Sequence Number: 14053655
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)190121
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2019
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1298057028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: AFX2 BIFURCATED STENT GRAFT. LOT 2317310008; BIFURCATED STENT GRAFT, LOT 1283287024; LIMB STENT GRAFT, LOT 1047167-011; MEDTRONIC (NON-ENDOLOGIX), STENT; VELA SUPRARENAL, LOT 1465954006; VELA SUPRARENAL, LOT 1472858006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR