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

Model Number	TV-IL1428140-J
Medical Device Problem Codes	Complete Blockage (1094); Off-Label Use (1494)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/27/2023
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.Devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation ix abdominal aortic aneurysm stent system.Approximately three (3) years post initial procedure, the patient presented emergently with bilateral claudication.Subsequent ct (computed tomography) scan revealed bilateral occlusions of the iliac limbs.The physician elected to treat the patient via thrombectomy, and the left iliac limb was confirmed as successfully opened; however, the right iliac remained closed.The physician plans to perform a femoral-femoral bypass at a later time to restore flow to the right limb.It is suspected that patient has covid and a clotting disorder.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation ix abdominal aortic aneurysm stent system.Approximately three (3) years post initial procedure, the patient presented emergently with bilateral claudication.Subsequent ct (computed tomography) scan revealed bilateral occlusions of the iliac limbs.The physician elected to treat the patient via thrombectomy, and the left iliac limb was confirmed as successfully opened; however, the right iliac remained closed.The physician plans to perform a femoral-femoral bypass at a later time to restore flow to the right limb.It is suspected that patient has covid and a clotting disorder.Additional information: clinical assessment identified that occlusion of the aorta was also present.In addition, the patient was initially implanted with a non-endologix device; the initial procedure was therefore outside the indications of use (off-label) due to adjunctive devices not compatible with the ovation ix system per device ifu.
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 the reported ovation ix, claudication, bilateral limb occlusion (right limb unresolved and determined to be a chronic occlusion) and additional endovascular procedure (interventional radiology thrombolysis) are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest aortic occlusion (just below the renal arteries) occurred that was not included in the event as reported.This finding was discovered during an examination of ct (computed tomography) scan dated (b)(6) 2023.The most likely causation for the reported event is user- and anatomy-related.It was reported that the patient was noncompliant with taking blood thinning medication, continued to smoke and was not consistent with follow-up exams or studies; this likely contributed to the reported event (anatomy- related).There was also concomitant product use of a non-endologix excluder iliac device (off-label condition), and the aorta and iliacs were thrombus laden prior to initial implant (cautionary product use condition).No procedure-related harms were identified.The final patient status was reported as discharged home on postoperative day three, and medically stable.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
• 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: 16770776
• Report Number: 3008011247-2023-00046
• Device Sequence Number: 3251390
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428140J1
• UDI-Public: +M701TVIL1428140J1/$$3210928FS09211834
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/27/2023

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: 09/28/2021
• Device Model Number: TV-IL1428140-J
• Device Catalogue Number: TV-IL1428140-J
• Device Lot Number: FS092118-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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 EXCLUDER; OVATION IX ILIAC LIMB, LN FS092618-26; OVATION IX ILIAC LIMB, LN FS092618-26; OVATION IX MAIN BODY, LN FS072419-14; OVATION IX MAIN BODY, LN FS072419-14; OVATION PRIME FILL POLYMER, LN FF031819-01; OVATION PRIME FILL POLYMER, LN FF031819-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male