MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; MAIN BODY

Model Number	TV-AB2680-N
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
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 remains implanted.
Event or Problem Description
The patient was being implanted with an alto abdominal stent graft system.During the procedure, it was reported that an intraoperative 1a endoleak was identified.The intraoperative 1a endoleak still remains.The physician elected to complete the case and will monitor the patient.
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 was completed.An examination of medical records and/or medical imaging received by endologix shows that the type 1a endoleak is confirmed.This is consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.It was reported the neck may have dilated prior to evar (ct scan done 5 months prior).It was noted in the operative note the neck appeared shorter than the pre procedure imaging showed.The final patient status was discharged on the second post operative day home.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.
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 was completed.An examination of medical records and/or medical imaging received by endologix shows that the type 1a endoleak is confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the event is anatomy related.It was reported the neck may have dilated prior to evar (ct scan done 5 months prior).It was noted in the operative note the neck appeared shorter than the pre procedure imaging showed.The measurement just below the lowest renal artery increased from 20.3mm to 21.8mm and at the first sealing ring (p2+7) from 22mm to 25mm (from procedure planning sheet until (b)(6) 2021 ct scan).This neck diameter growth was enough to increase the aortic body required to 29mm.The disease progression likely contributed to the type ia endoleak.The final patient status was discharged on the second post operative day home.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.Correction: h6: result code: remove code 3233.H6: conclusion code: remove code 4315.

• Brand Name: ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 12540749
• Report Number: 3008011247-2021-00114
• Device Sequence Number: 17171997
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680N1
• UDI-Public: +M701TVAB2680N1/$$3240105FS01042105
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

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: 01/05/2024
• Device Model Number: TV-AB2680-N
• Device Catalogue Number: TV-AB2680-N
• Device Lot Number: FS010421-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/17/2021; 11/03/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/27/2021; 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB (B)(6).; OVATION IX ILIAC LIMB (B)(6).; OVATION PRIME FILL POLYMER (B)(6).; OVATION IX ILIAC LIMB FS051820-23; OVATION IX ILIAC LIMB FS061021-14; OVATION PRIME FILL POLYMER FF042921-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female