MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	IS20-25/C55 SA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/20/2016
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.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
The patient was initially implanted with a bifurcated stent graft, two (2) suprarenal stent graft extensions and a limb graft extension to treat an abdominal aortic aneurysm (aaa).Reportedly, at the end of the procedure an angiogram was performed and an intraoperative 1b endoleak was identified.The physician elected to monitor the patient.Approximately, 1 month post initial procedure a re-intervention was completed to resolve the endoleak and patient was treated with a non- endologix stent (pxc121000 left) , and coil embolization.Note: approximately 2 years post re-intervention a small type 2 endoleak (non device realted) was identified to the right of the distal aortic stent graft.Reportedly, patient refused re-intervention and was referred to hospice.Patient was advised that an untreated type 2 endoleak can rupture and cause death.Patient expired on (b)(6) 2018; no further information was provided.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status after the secondary procedure 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: g1/g2: contact office - name has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11720644
• Report Number: 2031527-2021-00171
• Device Sequence Number: 3766031
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)181216
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 12/16/2018
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253188007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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 GRAFT, LOT#1342798002; VELA SUPRARENAL, LOT#1469349023; VELA SUPRARENAL, LOT#1469356020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR