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

Model Number TV-IL1410160-J

Device Problems Partial Blockage (1065); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems Thrombus (2101); Stenosis (2263)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).During the initial implant procedure and post polymer fill of the aortic body stent graft, the patient experienced hypotension due to a suspected polymer leak and was successfully treated for an anaphylactic reaction per the device ifu.Reference mfr.Report # 3008011247-2018-00109 for this previous reported event to the patient.Now approximately two and a half (2.5) years post initial procedure during a routine follow-up, a computed tomography (ct) scan revealed the right-side limb is significantly stenosed with intra-graft thrombus.No endoleak was identified and the aaa regressed and appears sealed.Re-intervention was completed on (b)(6) 2020 with the implant of two (2) ovation ix iliac limbs.The patient is doing well post procedure.

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 right iliac limb stenosis is confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the iliac limb stenosis is most likely user and anatomy related due to the concomitant product use of a non endologix stent in the right external iliac artery and the pre-existing right external iliac artery stenosis.The final patient status was reported to be well following a secondary endovascular 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: g1/g2: contact office - name has been updated.G4: date received by manufacturer has been updated.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: 11143521
• MDR Text Key: 226010928
• Report Number: 3008011247-2021-00003
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410160J1
• UDI-Public: +M701TVIL1410160J1/$$3201024FS100317067
• 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: 12/16/2020

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: 10/24/2020
• Device Model Number: TV-IL1410160-J
• Device Catalogue Number: TV-IL1410160-J
• Device Lot Number: FS100317-06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (FS020318-26); OVATION IX MAIN BODY (FS010218-60); OVATION PRIME FILL POLYMER (FF022818-01)
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR