MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; EXTENDER

Model Number	TV-EX282845-J
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2021
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 initially implanted with an afx2 bifurcated stent graft, a vela suprarenal aortic extension and two (2) ovation ix extenders to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately two (2) years post initial procedure, a computed tomography (ct) scan was performed for another medical issue and identified a type 1b endoleak from the patient's right iliac and a type 2 endoleak from the inferior mesenteric artery (ima).The physician elected to coil the ima, covered the right hypogastric artery and extended into the external iliac artery with an ovation ix iliac limb to successfully resolve this event.The patient was reported as fine post secondary procedure.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 ib endoleak (of the right common iliac artery(rcia)), non-device-related type ii endoleak (of the internal mesenteric artery) and secondary endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related due to the bilateral concomitant product use of ovation extenders in the iliacs at the index procedure (off-label), and the rcia measuring 28.8mm per pre-index procedure ct (computed tomography) scan (ifu diameter should be 10-23mm).Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was discharged home on the first post-operative day following a secondary endovascular repair procedure.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.

• Brand Name: OVATION IX
• Common Device Name: EXTENDER
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12089508
• Report Number: 3008011247-2021-00066
• Device Sequence Number: 11593962
• Product Code: MIH
• UDI-Device Identifier: M701TVEX282845J1
• UDI-Public: +M701TVEX282845J1/$$3210801FS072518084
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2021

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: 08/01/2021
• Device Model Number: TV-EX282845-J
• Device Catalogue Number: TV-EX282845-J
• Device Lot Number: FS072518-08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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: AFX VELA SUPRARENAL EXTENSION, LOT # 1958694005; AFX2 BIFURCATED STENT GRAFT, LOT # 1968555009; OVATION IX EXTENDER, LOT # FS080717-09
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR