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

Model Number	TV-IL1422120-J
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Vascular Dissection (3160)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.Reportedly, during index procedure the physician covered the left hypogastric artery with a limb.At the final angiogram it was identified that the right limb was no longer in the common iliac and there was a type ib endoleak coming from the right side.Additionally, it was observed that the left hypogastric artery which was covered by the limb was still filling.The physician elected to end the procedure to send patient out to larger center to have the left hypogastric artery coiled using access up and over the aortic bifurcation coming from the right side and did not want to extend right limb resolving the type ib endoleak until the coiling was completed.One day post initial implant, coiling of the left hypogastric was completed and implant of two ovation ix iliac limbs on the right side resolved the type ib endoleak.The patient is reported to be well post reintervention.
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 1b endoleak of the right common iliac artery, intraoperative right limb migration, a type 2 endoleak of the left internal iliac artery and the secondary endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.The type 2 endoleak is most likely anatomy related (non-device related).Device, user, procedure or anatomy relatedness of the type 1b endoleak could not be determined.The procedure related harm identified was a right external iliac artery dissection.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The left common iliac artery was 37mm in diameter should be 8-25mm.Since the type 1b endoleak with stent migration in the right common iliac artery was reported, this did not appear to contribute to the reported event.The final patient status was discharged on the sixth 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.Corrections: h6: investigation finding: remove code 3233.H6: investigation conclusion: remove code 11.

• 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: 13192467
• Report Number: 3008011247-2022-00003
• Device Sequence Number: 5984350
• Product Code: MIH
• UDI-Device Identifier: 00850007370336
• UDI-Public: (01)00850007370336(17)240626(10)FS062621-04
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/29/2021

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: 06/26/2024
• Device Model Number: TV-IL1422120-J
• Device Lot Number: FS062621-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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: ALTO MAIN BODY (LN FS082321-05); OVATION IX ILIAC LIMB (LN FS021220-17); OVATION IX ILIAC LIMB (LN FS110121-10); OVATION PRIME FILL POLYMER (LN FF061021-01)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male