MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1412120-J
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Unspecified Infection (1930); Obstruction/Occlusion (2422)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system (one (1) alto main body and three (3) ovation ix iliac limbs).Post-deployment, while attempting to advance the q50 merit medical balloon to mold the rings, the nose cone of the balloon became caught on the distal suprarenal portion of the alto main body, pushing the alto main body proximally about 1 cm and partially covering left renal.Arm access was obtained, and the left renal was successfully stented.There seemed to be seal in the neck at the second ring however a type 2 endoleak confirmed to still be present.This event has been reported under mrn 3008011247-2022-00047.Several hours post-procedure the patient developed a cold leg and was brought back into the operating room.The right limb was not getting flow do to the alto main body legs becoming a little twisted and occluding on the right side.Two (2) non-endologix balloon-expandable stents were implanted at the level of the second sealing ring and into the legs of the main body.Normal flow was achieved.The final angiogram looked perfect.The patient was reported to be doing well.This event has been reported under mrn 3008011247-2022-00050.During the investigation of these previous cases, an iliac occlusion (unclear if right or left side) had occurred 8 days after the initial procedure was identified and a suspected / possible abdominal abscess or infection was also noted.The suspected / possible abdominal abscess or infection has not been confirmed to be device related at this time.The current patient status is unknown but additional information has been requested.
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will 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.
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 abdominal infection or abscess is refuted, rather there was a urinary tract infection with sepsis (e.Coli).This infection is not device related.The iliac occlusion in the left iliac artery is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest an additional surgical procedure (left ax-fem bypass) was performed eight (8) days post the initial procedure that was not included in the event as reported.The procedure was discovered during a review of the discharge summary.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review; however, no procedure related harms for this complaint were identified.The final patient status was discharged on post operative day eleven to an acute rehabilitation facility.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.Corrections: b2: outcomes attributed to adverse events has been updated b5: describe event or problem has been updated g3: date received by manufacturer has been updated h6: health effect - clinical code: remove code 1930 h6: health effect impact code: remove code 4614 h6: investigation finding: remove code 3233 h6: investigation conclusion: remove code 11.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system (one (1) alto main body and three (3) ovation ix iliac limbs).Post-deployment, while attempting to advance the q50 merit medical balloon to mold the rings, the nose cone of the balloon became caught on the distal suprarenal portion of the alto main body, pushing the alto main body proximally about 1cm and partially covering left renal.Arm access was obtained, and the left renal was successfully stented.There seemed to be seal in the neck at the second ring however a type 2 endoleak confirmed to still be present.This event has been reported under mrn 3008011247-2022-00047.Several hours post-procedure the patient developed a cold leg and was brought back into the operating room.The right limb was not getting flow due to the alto main body legs becoming a little twisted and occluding on the right side.Two (2) non-endologix balloon-expandable stents were implanted at the level of the second sealing ring and into the legs of the main body.Normal flow was achieved.The final angiogram looked perfect.The patient was reported to be doing well.This event has been reported under mrn 3008011247-2022-00050.During the investigation of these previous cases, an iliac occlusion (unclear if right or left side) had occurred 8 days after the initial procedure was identified and a suspected / possible abdominal abscess or infection was also noted.The suspected / possible abdominal abscess or infection has not been confirmed to be device related at this time.The current patient status is unknown but additional information has been requested.Additional information: an internal clinical assessment determined that there was evidence to reasonably suggest an additional surgical procedure (left ax-fem bypass) was performed eight (8) days post the initial procedure that was not included in the event as reported.The procedure was discovered during a review of the discharge summary.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• 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: 15089208
• Report Number: 3008011247-2022-00083
• Device Sequence Number: 5048815
• Product Code: MIH
• UDI-Device Identifier: 00850007370176
• UDI-Public: (01)00850007370176(17)250211(10)FS021122-01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 02/11/2025
• Device Model Number: TV-IL1412120-J
• Device Lot Number: FS021122-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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: NON- ENDOLOGIX, TWO (2) BALLOON-EXPANDABLE STENTS.; OVATION ALTO, MAIN BODY, LOT FS021222-11.; OVATION IX, ILIAC LIMB, LOT FS021922-11.; OVATION IX, ILIAC LIMB, LOT FS030922-43.; OVATION, POLYMER, LOT FF070121-03.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male