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

Model Number	TV-AB3480-J
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	07/22/2022
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 initially implanted with an ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that during the initial procedure the graft was difficult to demate, the implant was displaced and there was type 1a endoleak.This patient was not in routine follow-up care.Now, approximately six years post implant the physician reported that the aaa ruptured from a type 1 endoleak.Upon further review it appears there was a juxtarenal aneurysm that may have caused the rupture as there was no visible type 1a endoleak and the issue appears to be where that proximal crown is above the ovation ix fabric.The physician elected to implant a cook pmeg (physician modified endograft) (non-endologix) stent to resolve this event.The patient was reported as doing well post this secondary procedure.
Event or Problem Description
Clarification of reported event: the patient was initially implanted with an ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that during the initial procedure the graft was difficult to demate, the implant was displaced and there was type 1a endoleak.This event was previously captured per patient id (b)(6).Patient was not in routine follow-up care.Now, approximately six (6) years post implant the physician reported that the aaa ruptured from a type 1 endoleak.Upon further review it appears there was a juxtarenal aneurysm that may have caused the rupture as there was no visible type 1a endoleak, and the issue appears to be where that proximal crown is above the ovation ix fabric.The physician elected to implant a cook pmeg (physician modified endograft) (non-endologix) stent to resolve this event.The patient was reported as doing well post this secondary procedure on (b)(6) 2022.Additional information per clinical assessment: during the initial implant procedure, a laceration occurred that required emergent repair.In addition, patient returned to the hospital twelve (12) days post initial procedure for blood transfusion and left groin hematoma evaluation.A separate report will be filed for this event under patient id (b)(6).
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 1a endoleak, ruptured abdominal aortic aneurysm and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest the following occurred which were not included in the event as reported: a femoral artery laceration during the index procedure necessitating emergent repair, and blood transfusion with evaluation for postoperative left groin hematoma at twelve days post index procedure.These findings were discovered during an examination of the discharge summary dated (b)(6) 2016.No procedure-related harms were identified for this event in year 2022; 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 to be discharged to an acute rehabilitation facility on post operative day five.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: b5 describe event or problem.E1 physician information.G3 awareness date.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

• 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: 15207323
• Report Number: 3008011247-2022-00086
• Device Sequence Number: 4717330
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3190615FS03071636C
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 06/30/2019
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS030716-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• 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, LOT # FS040116-46; OVATION IX ILIAC LIMB, LOT # FS121814-09; OVATION PRIME FILL POLYMER, LOT # FF031416-02
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown