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

Model Number TV-IL1412140-J

Device Problems Off-Label Use (1494); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 12/29/2021

Event Type  Injury  

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix stent graft system.Approximately three (3) years post initial procedure a type ia endoleak, and a type ib endoleak were identified during routine follow-up.Successful reintervention was performed with implant of an palmaz (non-endologix) to treat the type ia endoleak and an ovation extender to treat the type ib endoleak.The patient was reported to be stable post-reintervention.

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.Approximately three (3) years post initial procedure a type ia endoleak, and a type ib endoleak were identified during routine follow-up.Successful reintervention was performed with implant of an palmaz (non-endologix) to treat the type ia endoleak and an ovation extender to treat the type ib endoleak.The patient was reported to be stable post-reintervention.Additional information: the clinical assessment determined that there was evidence to reasonably suggest left iliac stent cranial migration of 21 mm occurred that was not included in the event as reported.The cranial migration was discovered during a review of the 35 month post index ct scan.

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.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 ia endoleak, type ib endoleak from the left common iliac artery and the additional endovascular procedure were confirmed.This is consistent with the reported adverse event/incident.Additionally, the clinical assessment determined that there was evidence to reasonably suggest left iliac stent cranial migration of 21 mm occurred that was not included in the event as reported.Also the left external artery was occluded but distal to the left internal iliac artery and left iliac stent there was not device related.These were discovered during a review of the 35 month post index ct scan.Device, user or procedure for the type 1a endoleak could not be determined however the type 1b endoleak and migration were user related due to the left common iliac artery diameter being off- label at 7.2mm (per ifu should be 8-25mm).No procedure related harms were identified.The final patient status was discharged on the first post operative day home in stable condition.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: b5: describe event or problem - updated.G3: date received by manufacturer - updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 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: 13179247
• MDR Text Key: 288190901
• Report Number: 3008011247-2022-00002
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412140J1
• UDI-Public: +M701TVIL1412140J1/$$3210521FS05171803G
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: TV-IL1412140-J
• Device Catalogue Number: TV-IL1412140-J
• Device Lot Number: FS051718-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• 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 FS032818-09).; OVATION IX MAIN BODY (LN FS061818-59).; OVATION PRIME FILL POLYMER (LN FF072018-01).
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male