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

Model Number	TV-AB3480-N
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation.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 alto abdominal aortic aneurysm stent system.During the initial implant procedure, the patient's common iliac ruptured while the physician unsuccessfully attempted to snare the guidewire through the crossover lumen, but lost wire access due to retracting the sheath too far.In response, the physician converted to open repair, after which the patient's blood pressure dropped.The physician treated the hypotension with fluids and epinephrine, however the patient is reportedly in poor condition and not producing urine output post procedure.It was noted that the patient had pre-existing, high creatinine levels and was believed to only have one functioning kidney; this is why the physician chose to not inject much contrast during the procedure.The patient also had heavy calcified disease in the left, proximal common iliac with a sharp hairpin turn that was underappreciated.
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 that the intraoperative, difficult to advance (difficult cannulation of the left common iliac artery) is confirmed.The rupture, surgical conversion (open repair) and hypotension are confirmed.This is consistent with the reported adverse event/incident.There was significant angulation in the left common iliac artery, associated with thick calcifications and a focal stenosis of 2.3mm.This likely contributed to the difficulty in cannulation (anatomy related).It was reported the physician retracted the 12 french introducer too far for the cross over lumen wire to be able to be snared.This likely contributed to the reported event (user related).The thickened calcifications in the distal seal zone is a cautionary product use condition.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms are renal failure (long term dialysis) and respiratory complications (prolonged intubation).The final patient status was reported as discharge on postoperative day eighteen.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: h6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: ALTO
• Common Device Name: MAIN BODY DELIVERY YSTEM
• 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: 18052174
• Report Number: 3008011247-2023-00183
• Device Sequence Number: 6060685
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)250713(10)FS060922-59
• 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: 2023
• 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): 10/11/2023

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: 07/13/2025
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS060922-59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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: OVATION PRIME FILL POLYMER, LN FF072123-01.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female