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

Model Number	TV-IL1422160-J
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It should be noted that this patient has known pvd (peripheral vascular disease).At the time of the initial procedure the aaa was sealed and there was no flow limiting issues in the common/external iliac arteries.It should also be noted that there were unsuccessful attempts in placing perclose (non-endologix) closure devices pre-case, and the physician decided to use single perclose on both groins.It was reported that two (2) days after the initial procedure the patient had acute rle (right lower extremity) issue.The physician elected to perform additional surgery to repair.The patient's status was not reported.
Additional Manufacturer Narrative
During the investigation of this complaint it was determined that this event is not a device failure of the ovation limb stent and therefore, a complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that thrombosis and occlusion event of the non endologix right superficial artery stent was confirmed.This is consistent with the reported adverse event/incident.Additionally, the clinical evaluation shows that this event is not a device failure of the ovation limb stent, rather the right superficial femoral artery stent was in place prior to the evar for peripheral vascular disease.The final patient status was discharged home on the fifth post operative day.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It should be noted that this patient has known pvd (peripheral vascular disease).At the time of the initial procedure the aaa was sealed and there was no flow limiting issues in the common/external iliac arteries.It should also be noted that there were unsuccessful attempts in placing perclose (non-endologix) closure devices pre-case, and the physician decided to use single perclose on both groins.It was reported that two (2) days after the initial procedure the patient had acute rle (right lower extremity) issue.The physician elected to perform additional surgery to repair.The patient's status was not reported.Additional information: during the clinical assessment it was found that this event is not a device failure of the ovation limb stent, rather the right superficial femoral artery stent was in place prior to the evar for peripheral vascular disease.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12080483
• Report Number: 3008011247-2021-00065
• Device Sequence Number: 14283669
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422160J1
• UDI-Public: +M701TVIL1422160J1/$$3210829FS08271830Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 08/29/2021
• Device Model Number: TV-IL1422160-J
• Device Catalogue Number: TV-IL1422160-J
• Device Lot Number: FS082718-30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTO MAIN BODY, LOT # FS031821-27; OVATION IX ILIAC LIMB, LOT # FS043021-16; OVATION PRIME FILL POLYMER, LOT # FF010821-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR