MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2980-J
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	08/13/2020
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 ovation ix abdominal aortic aneurysm stent system.Approximately three and a half (3.5) years post initial procedure, the patient presented with a significant increase in the aneurysm sac from 5.2cm to 6cm (greater than 5mm growth), a type ii endoleak (non-device-related) and a type iii endoleak (of indeterminate origin).The physician elected to treat the patient by implanting two (2) gore (non-endologix) excluder aaa endoprosthesis cuffs on 13 august 2020.At the conclusion of the secondary procedure, a small blush of contrast was visualized.During follow-up on 03 september 2020, a persistent type iii endoleak was detected per ct (computed tomography) scan and angiogram.The physician elected to re-intervene on 30 october 2020 by implanting two (2) non-endologix limb extensions, one per iliac/side.At the conclusion of the tertiary procedure, no evidence of a type iii endoleak was visualized per contrast aortogram.During follow-up on 16 march 2021 and 06 october 2021, a persistent type iii endoleak was detected per ct/angiogram.The physician elected to continue monitoring the patient due to a "stable aneurysm sac size without increase".Reportedly, the consumer indicated that "the use of a liquid polymer seal in [the] product exposed [patient] to the risk of polymer leaks during and after implantation of the device".
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 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 reported type ii endoleak (of the lumbar artery), aneurysm sac growth (of 14mm) and additional endovascular procedures on 13 august 2020 and 30 october 2020 are confirmed.The reported type iii endoleak is unconfirmed, and the polymer leak is refuted.This is moderately consistent with the reported adverse event/incident.The operative note dated 20 december 2016 states, "polymer prepped and delivered under constant infusion through dedicated injector and specific port over 20 min.While polymer infusing, contra[lateral] limb cannulated & right limb deployed".This is consistent with ifu protocols, and no patient reaction was observed; a polymer leak can only occur during the polymer fill step of the index implantation procedure, hence the reported polymer leak is refuted.No procedure-related harms were identified.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was reported as under surveillance on 06 october 2021.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation ix abdominal aortic aneurysm stent system.Approximately three and a half (3.5) years post initial procedure, the patient presented with a significant increase in the aneurysm sac from 5.2cm to 6cm (greater than 5mm growth), a type ii endoleak (non-device-related) and a type iii endoleak (of indeterminate origin).The physician elected to treat the patient by implanting two (2) gore (non-endologix) excluder aaa endoprosthesis cuffs on 13 august 2020.At the conclusion of the secondary procedure, a small blush of contrast was visualized.During follow-up on 03 september 2020, a persistent type iii endoleak was detected per ct (computed tomography) scan and angiogram.The physician elected to re-intervene on 30 october 2020 by implanting two (2) non-endologix limb extensions, one per iliac/side.At the conclusion of the tertiary procedure, no evidence of a type iii endoleak was visualized per contrast aortogram.During follow-up on 16 march 2021 and 06 october 2021, a persistent type iii endoleak was detected per ct/angiogram.The physician elected to continue monitoring the patient due to a "stable aneurysm sac size without increase".Reportedly, the consumer indicated that "the use of a liquid polymer seal in [the] product exposed [patient] to the risk of polymer leaks during and after implantation of the device".Additional information: the reported polymer leak is refuted per clinical assessment.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• 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: 15510193
• Report Number: 3008011247-2022-00121
• Device Sequence Number: 17652570
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3190907FS04201671F
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS042016-71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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: OVATION IX ILIAC LIMB, LN FS042216-41; OVATION IX ILIAC LIMB, LN FS062916-29; OVATION PRIME FILL POLYMER, LN FF040516-03
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male