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

Model Number TV-IL1428140-J

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/13/2024

Event Type  Injury  

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.

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2024.Approximately two (2) months after the initial procedure, the patient presented with a thrombosed left iliac limb.The physician elected to perform a procedure to address the thrombosis, including mechanical clot removal and relining of the limb with a gore (non-endologix) vbx stent graft and an ovation ix iliac limb.Additionally, the other limb received a gore (non-endologix) vbx stent graft (kissing stents) to maintain patency.The patient's status was reported as stable following the secondary procedure.

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix confirms the ovation ix, left limb occlusion, and two additional endovascular procedure complaints.This is consistent with the reported adverse event/incident.The ipsilateral right limb landed in the infrarenal angulation of 50.7°.The contralateral limb is 7.1 mm below the ipsilateral limb.The position and angulation could have contributed to the reported event, but this was not conclusively determined.The clinical evaluation also shows reasonable evidence to suggest that stent buckling (left common iliac artery) occurred.The left common iliac artery stent buckling was discovered during a review of the operative report dated (b)(6), 2024.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported as discharged home on hospital day five and postoperatively on day one.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: g3: awareness date ¿ 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: 19030446
• MDR Text Key: 339207443
• Report Number: 3008011247-2024-00036
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370091
• UDI-Public: (01)00850007370091(17)260913(10)FS091323-04
• 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
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: TV-IL1428140-J
• Device Lot Number: FS091323-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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: ALTO MAIN BODY FS111623-12; OVATION IX ILIAC LIMB FS092023-05; OVATION PRIME FILL POLYMER FF101623-01
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female