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

Model Number TV-IL1422160-J

Device Problem Complete Blockage (1094)

Patient Problems Occlusion (1984); Thrombus (2101); Stenosis (2263)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with an ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) months post initial procedure the patient came back with an occluded left iliac.The patient was brought back for re-intervention on (b)(6) 2021.The patient was found to have thrombus in the contralateral limb.The physician elected to use thrombolysis on the patient overnight and bring them back to the operating room (or) on the following day to assess.On (b)(6) 2021 the thrombus had resolved and it was noted the patient had stenosis at the distal edge of the contralateral limb.The physician decided to use a (non endologix) 10x38 icast stent.It was implanted with good results and the patient was discharged to return home.

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 left limb stent occlusion and right limb stenosis.This is consistent with the reported adverse event/incident.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 being stable post the re-intervention procedure.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: result code: remove code 3233.H6: conclusion code: 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
• MDR Report Key: 11216316
• MDR Text Key: 228406223
• Report Number: 3008011247-2021-00007
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422160J1
• UDI-Public: +M701TVIL1422160J1/$$3200906FS08291704V
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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 Expiration Date: 09/06/2020
• Device Model Number: TV-IL1422160-J
• Device Catalogue Number: TV-IL1422160-J
• Device Lot Number: FS082917-04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB FS030220-53; OVATION IX MAIN BODY FS012420-18; OVATION PRIME FILL POLYMER FF021120-01
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR