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

Model Number	TV-IL1410100-J
Medical Device Problem Codes	Complete Blockage (1094); Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2021
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 initially implanted with the ovation alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that while the patient was in recovery the patients left limb and external iliac immediately occluded and the physician had to perform a fem bypass.Patient was discharged on an unknown date.Now, the patient has presented with severe groin infection from the fem bypass and possible multiple type ii endoleaks.Patient is in critical condition recovering from the infection and re-intervention is being discussed, but not yet scheduled.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported left limb occlusion, multiple type ii endoleaks (non-device-related) from the lumbar arteries, the femoral-femoral bypass and left groin infection are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest left foot ischemia due to an infected femoral-femoral bypass graft (non-device-related), multiple additional surgical procedures and a type ia endoleak occurred that were not in the event as reported.These findings were discovered during an examination of the operative notes dated (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021.The device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.A contributing factor to the reported event includes the left iliac artery diameter measuring 7.5mm (ifu requirement is 8-25mm), which likely contributed to the reported occlusion.Procedure-related harms include groin infection, additional surgical procedures and left foot ischemia.The final patient status was reported as being in critical condition recovering from an infection.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 ae.B3 date of event.B5 describe event or problem.D11 therapy dates.Section e; initial reporter.G4 awareness date.H6 device codes (as evaluated); remove 3190.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.
Event or Problem Description
The patient was initially implanted with the ovation alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that while the patient was in recovery the patients left limb and external iliac immediately occluded and the physician had to perform a fem fem bypass.Patient was discharged on an unknown date.Now, the patient has presented with severe groin infection from the fem fem bypass and possible multiple type ii endoleaks.Patient is in critical condition recovering from the infection and re-intervention is being discussed, but not yet scheduled.Additional information received per clinical assessment indicating that non-device-related left foot ischemia (due to infected femoral-femoral bypass graft) and a type ia endoleak also occurred at the time of the reported event.Note: the type ia endoleak self-resolved within 30 days (no treatment was required).

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11868134
• Report Number: 3008011247-2021-00046
• Device Sequence Number: 11613526
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410100J1
• UDI-Public: +M701TVIL1410100J1/$$3231111FS11102040Z
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 11/11/2023
• Device Model Number: TV-IL1410100-J
• Device Catalogue Number: TV-IL1410100-J
• Device Lot Number: FS111020-40
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/22/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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: ALTO MAIN BODY, SN (B)(6); FILL POLYMER, SN FF102820-01; OVATION ALTO MAIN BODY (B)(6); OVATION IX ILIAC LIMB (B)(6); OVATION IX ILIAC LIMB, SN (B)(6)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 86 YR