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

Model Number	TV-IL1422160-J
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Unspecified Infection (1930); Pseudoaneurysm (2605); Clinical Endoleak (4843)
Date of Event	02/19/2023
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 initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately three (3) months post initial procedure, the patient presented with a type ib endoleak, an increased aneurysm sac (unknown diameter) of the left external iliac artery (leia), a contained pseudoaneurysm and graft infection.The patient has been administered antibiotics.The physician elected to treat the patient by coiling the internal iliac artery and extending the iliac stent into the leia with two (2) additional ovation ix iliac limbs on 21 february 2023 (in order to exclude the persistent sciatic artery).Blood cultures were also repeated, and patient is reportedly in stable condition.The physicians plans to further treat by converting patient to open repair with explantation of the graft, but this surgery has not been scheduled.
Additional 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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported graft infection and explant procedure are confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the graft infection and explant event is anatomy-related due to the pre-existing infection (either due to the left lower extremity infection, or the pericolonic abscess).No procedure-related harms were identified.It was also noted that the patient was admitted on 02 february 2023 with gas bacteremia and sepsis (most likely related to a skin and soft tissue infection of the left lower extremity).There was a pericolonic abscess, a potential source of the sepsis.The bacteremia, endocarditis and acute renal failure were indicated as not device-related per the clinical documentation.The final patient status was reported as discharged in improved and stable condition on the seventh post operative day.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: b3 date of event, b5 describe event or problem, d10 concomitant products, g3 awareness date.H6 health effect - clinical code; remove 1708, 2605 and 4843.H6 health effect - impact code; remove 4625.H6 medical device problem codes; remove 4065.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately three (3) months post initial procedure, the patient presented with a type ib endoleak, an increased aneurysm sac (unknown diameter) of the left external iliac artery (leia), a contained pseudoaneurysm and graft infection.The patient has been administered antibiotics.The physician elected to treat the patient by coiling the internal iliac artery and extending the iliac stent into the leia with two (2) additional ovation ix iliac limbs on (b)(6) 2023 (in order to exclude the persistent sciatic artery).Blood cultures were also repeated, and patient is reportedly in stable condition.The physicians plans to further treat by converting patient to open repair with explantation of the graft, but this surgery has not been scheduled.Additional information: the physician elected to treat the patient by explanting the devices on (b)(6) 2023.Clarification: this report # 3008011247-2023-00028 is to address event of graft infection with tertiary intervention (via explant) on (b)(6) 2023.Reference mfr.Report # 3008011247-2023-00143 for previous event of patient admitted on (b)(6) 2023 for coiling of the left internal iliac artery with left iliac stent placement (secondary intervention) due to a type ib endoleak, left iliac pseudoaneurysm, cranial migration, aneurysm enlargement, aortic stenosis and a suspect, contained rupture.

• 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: 16503518
• Report Number: 3008011247-2023-00028
• Device Sequence Number: 3353444
• Product Code: MIH
• UDI-Device Identifier: 00850007370350
• UDI-Public: (01)00850007370350(17)250616(10)FS061622-17
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 06/16/2025
• Device Model Number: TV-IL1422160-J
• Device Catalogue Number: TV-IL1422160-J
• Device Lot Number: FS061622-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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 FS092322-28; ALTO MAIN BODY, LN FS092322-28; NON-ENDOLOGIX ILIAC STENT (LEFT); OVATION IX ILIAC LIMB, LN FS070522-31; OVATION IX ILIAC LIMB, LN FS070522-31; OVATION PRIME FILL POLYMER, LN FF032822-01; OVATION PRIME FILL POLYMER, LN FF032822-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male