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

Model Number	TV-IL1428160-J
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2022
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.Device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto abdominal stent graft system (one (1) alto mail body and two (2) ovation ix iliac limbs).An intraoperative type 1b endoleak occurred due to the closure device moving the ovation ix limb.The following day the physician elected to do a re-intervention and elected to implanted an ovation ix extender and ovation ix iliac limb to resolved the type 1b endoleak.The patient was reported to be doing well.
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 could not be completed.No medical records or medical imaging relevant to the adverse event/incident was received by endologix.Due to the absence of relevant medical records and reported medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being in stable condition.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: a3; remove sex.H6 medical device problem codes; remove 1395.H6 investigation finding codes; remove 3233.H6 investigation finding codes; remove 11.
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 ovation ix dislodged implant is unconfirmed.There was no comparison imaging to identify where the inferior stent margin landed at the index procedure and whether any movement took place.The type 1b endoleak and the additional endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.The device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.It was reported that "an intraoperative type 1b endoleak occurred due to the closure device moving the ovation ix limb".In addition, the proximal right common iliac artery was 28.3mm (off label as device ifu requirement is 8-25mm).However, it could not be conclusively determined whether the closure device movement or this off ifu condition contributed to the reported event.The final patient status was reported as doing well.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: g3: date of received by manufacturer h10/11 additional manufacturer narrative/corrected data; updated narrative.

• 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: 14699595
• Report Number: 3008011247-2022-00064
• Device Sequence Number: 6637257
• Product Code: MIH
• UDI-Device Identifier: 00850007370008
• UDI-Public: (01)00850007370008(17)250214(10)FS021222-51
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2025
• Device Model Number: TV-IL1428160-J
• Device Lot Number: FS021222-51
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022; 11/16/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/04/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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 FS020722-55; OVATION IX ILIAC LIMB FS120321-37; OVATION PRIME FILL POLYMER FF102121-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male