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

Model Number TV-IL1428100-J

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 02/13/2022

Event Type  Injury  

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 Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix stent graft system.Reportedly, at the index procedure the common iliac artery was aneurysmal.Approximately four (4) years post initial procedure routine follow-up identified that the ovation ix iliac limb on the left side had retracted into the aneurysm sac and that there was a type ib endoleak.Reintervention was completed with implant of two ovation ix iliac limbs on the left side sealing the type ib endoleak.The patient was reported to be good post-reintervention.

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 the reported type ib endoleak (of the left iliac stent), cranial migration (of approximately 60mm) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related due to the left iliac diameter measuring 32.3mm per pre-index ct (computed tomography) scan (should measure 8-25mm per ifu).No procedure-related harms for this event could be determined.The final patient status was discharged on the first postoperative day at home in stable conditon.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 codes; remove 3233.H6 investigation conclusion codes; remove 11.

• Brand Name: OVATION IX
• Type of Device: 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: 13653816
• MDR Text Key: 286455632
• Report Number: 3008011247-2022-00016
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428100J1
• UDI-Public: +M701TVIL1428100J1/$$3161027FS03041514I
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Model Number: TV-IL1428100-J
• Device Catalogue Number: TV-IL1428100-J
• Device Lot Number: FS030415-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS040816-48); OVATION IX MAIN BODY (LN FS121416-16); OVATION PRIME FILL POLYMER (LN FF112916-01)
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male