MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; MAIN BODY

Model Number	TV-AB2080-N
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263); Pseudoaneurysm (2605)
Date of Event	04/27/2022
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 implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the absence of an infrarenal neck.The physician elected to place the alto sealing ring between the right and left renal arteries and implanted a single renal chimney lifestream (non-endologix) balloon expandable stent (bes) into the left renal artery.A seal appeared to have been achieved; however, a type 1a endoleak was later observed.The patient status was reported as discharged.
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.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 that the type ia endoleak and the additional endovascular procedure is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation shows the most likely causation for this event was user related.This initial procedure is outside the indications of use due to the absence of an infrarenal neck (neck length 10mm and diameter at p2+7 was 10mm (should be 16-30.4mm).There was also concomitant product use of a left renal artery stent(off label).This likely contributed to the type ia endoleak.The challenging anatomy as noted in the procedure planning likely contributed to the twisting of the aortic body at index, which caused the aortic stenosis and additional endovascular procedure.Additionally, the clinical assessment determined there was evidence to reasonably suggest aortic stenosis with lower leg ischemia and an access site complication (pseudoaneurysm that resulted in an er visit and thrombin injection on 28 august 2022 occurred that was not included in the original complaint.The final patient status was reported as being discharged home 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.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the absence of an infrarenal neck.The physician elected to place the alto sealing ring between the right and left renal arteries and implanted a single renal chimney lifestream (non-endologix) balloon expandable stent (bes) into the left renal artery.A seal appeared to have been achieved; however, a type 1a endoleak was later observed.The patient status was reported as discharged.After the initial report, additional information was reported that reintervention was completed on 26 august 2022 to repair the aortic body twisting which occurred at the index procedure.The physician elected to place 2 bare metal stents (non-endologix) in the alto aortic body to open up the constrained area of the graft.Angiography and abi¿s indicated the procedure was successful and graft opened and the type 1a endoleak was also resolved with the coil procedure.The patient was discharged and is doing well.The clinical assessment determined there was evidence to reasonably suggest aortic stenosis with lower leg ischemia and an access site complication (pseudoaneurysm that resulted in an er visit and thrombin injection on 28 august 2022 occurred that was not included in the original complaint.

• Brand Name: ALTO
• 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: 14436237
• Report Number: 3008011247-2022-00048
• Device Sequence Number: 12038859
• Product Code: MIH
• UDI-Device Identifier: 00850007370381
• UDI-Public: (01)00850007370381(17)240222(10)FS02172126
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 04/27/2022

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: 02/22/2024
• Device Model Number: TV-AB2080-N
• Device Lot Number: FS021721-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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 # FS012022-62; OVATION IX ILIAC LIMB, LOT # FS102221-24; OVATION PRIME FILL POLYMER, LOT # FF050421-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female