MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; DELIVERY SYSTEM

Model Number	TV-AB2980-N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).During this initial procedure, the integrated balloon would not inflate which caused incomplete deployment of mid-crown.However, the final result was good and the patient was reported as doing well.The delivery system was returned and its evaluation has been completed.
Additional Manufacturer Narrative
The delivery system was returned for evaluation.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.Endologix received one (1) alto delivery system for an evaluation.The device was shipped in a large shipping box, within two biohazard bags, within the original product box.The stent graft was not returned as it was implanted in the patient as reported.There was blood residue present on the device.The sheath was not returned a visual and limited functional analysis were performed.Upon initial visual inspection the oval balloon fill tube exhibited a double kink at a distance of 8mm and 11mm proximal to the proximal lumen spacer in a "z" bend configuration.There was a kink also present in the oval balloon fill lumen at 4mm proximal to the proximal lumen spacer.The bond between the guide wire lumen and the proximal lumen spacer is compromised and the guide wire lumen is able to slide freely within the lumen spacer.There is a kink / radium present on the laser cut hypo tube at the transition from laser cut to solid tube region.The balloon luer connector was inspected and no defects were identified.For reference the device presented with the distal side of the distal stop fitting to proximal edge of the proximal lumen spacer at 9.5mm.A functional analysis was performed where a 30ml syringe filled with 30ml tap water was connected to the balloon fill port.When the device was held in a straight configuration, with a stiff wire through the guide wire lumen, the balloon was not able to be inflated or aspirated.When the oval fill lumen was placed on an inner curve, the balloon was not able to be filled.When the balloon lumen was placed on an outer curve configuration, the balloon was able to be filled with significant resistance and aspiration was significantly longer than expected.The complaint is confirmed.
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 returned device has been completed.Endologix received one (1) alto delivery system for an evaluation.The device was shipped in a large shipping box, within two biohazard bags, within the original product box.The stent graft was not returned as it was implanted in the patient as reported.There was blood residue present on the device.The sheath was not returned.A visual and limited functional analysis were performed.Upon initial visual inspection the oval balloon fill tube exhibited a double kink at a distance of 8mm and 11mm proximal to the proximal lumen spacer in a "z" bend configuration.There was a kink also present in the oval balloon fill lumen at 4mm proximal to the proximal lumen spacer.The bond between the guide wire lumen and the proximal lumen spacer is compromised and the guide wire lumen is able to slide freely within the lumen spacer.There is a kink / radium present on the laser cut hypo tube at the transition from laser cut to solid tube region.The balloon luer connector was inspected and no defects were identified.For reference the device presented with the distal side of the distal stop fitting to proximal edge of the proximal lumen spacer at 9.5mm.A functional analysis was performed where a 30ml syringe filled with 30ml tap water was connected to the balloon fill port.When the device was held in a straight configuration, with a stiff wire through the guide wire lumen, the balloon was not able to be inflated or aspirated.When the oval fill lumen was placed on an inner curve, the balloon was not able to be filled.When the balloon lumen was placed on an outer curve configuration, the balloon was able to be filled with significant resistance and aspiration was significantly longer than expected.The complaint is confirmed.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the unable to inflate the integrated balloon and unable to deploy mid-crown are confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.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.

• Brand Name: ALTO
• Common Device Name: DELIVERY SYSTEM
• 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: 17705359
• Report Number: 3008011247-2023-00162
• Device Sequence Number: 7399742
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)260310(10)FS030923-12
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2026
• Device Model Number: TV-AB2980-N
• Device Lot Number: FS030923-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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# FS011823-16; OVATION IX ILIAC LIMB, LOT# FS062922-55; OVATION PRIME FILL POLYMER, LOT# FF050923-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male