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

Model Number	TV-IL1410140-J
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/30/2023
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.
Event or Problem Description
The patient was being treated for a 7.7cm abdominal aortic aneurysm (aaa) that had previously ruptured and was contained.Details of the previous containment were not provided.Reportedly, the right common iliac was stenosed; however, there was no difficulty going through it and it was ballooned.The alto main body was deployed.Upon cannulation, the wire went up and appeared to go through the contralateral limb.The wire also went behind the sealing ring and up into the proximal aorta without an issue.Two 7x80 balloons were placed up into the gate, and it looked as if the delivery system was in two separate lumens inside the graft.The ovation ix iliac limbs were deployed.One was in the ipsilateral gate, and the other one was outside of the aortic body.The physician was unable to re-access the contralateral gate; therefore, the procedure was converted to an aorto-uni-iliac (aui).Though all stents deployed properly the physician misjudged where the wire was and thought the wire cannulated the contralateral gate and it did not.The surgery was a success.The patient is doing amazing.
Additional Manufacturer Narrative
The reported 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 the device 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 malposition of the ovation ix iliac limb (right contralateral wire advanced behind the sealing ring) with resultant contralateral limb being deployed outside the gate and conversion to aui procedure and femoral-to-femoral bypass complaints are confirmed.The complaint is most likely user related as this was an off-label case.The right common iliac artery maximum diameter was 6.0mm and the left common iliac artery maximum diameter was 5.8mm (should be 8-25mm).The patient has a history of peripheral vascular disease.The left common iliac and right common iliac arteries were occluded with previous stents - concomitant product use condition.This likely contributed to the reported events.The neck taper, non-conic shape was 13.8% (should be less than 10%).Additionally, there was a contained rupture of the aorta (cautionary product use).No procedure related harms were identified.The final patient status was reported to be discharged home on postoperative day two.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.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 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: 16803330
• Report Number: 3008011247-2023-00048
• Device Sequence Number: 19293353
• Product Code: MIH
• UDI-Device Identifier: 00850007370145
• UDI-Public: (01)00850007370145(17)250218(10)FS021722-07
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/30/2023

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: 02/18/2025
• Device Model Number: TV-IL1410140-J
• Device Catalogue Number: TV-IL1410140-J
• Device Lot Number: FS021722-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: ALTO MAIN BODY (LN FS110922-18).; OVATION IX ILIAC LIMB (LN FS062921-01).; OVATION PRIME FILL POLYMER (LN FF072822-01).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male