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

Model Number TV-AB2980-N

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

The devices involved in this event are expected to be returned for evaluation; however, they have not yet been received.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 Description

The patent was being treated for an abdominal aortic aneurysm on (b)(6) 2023.Reportedly, the polymer fill was extremely slow and it was at about five minutes when the ipsilateral limb finally started to show up (fill).The procedure was completed without any impact to the patient.

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.Endologix performed an evaluation of the returned alto delivery system.The device was received in the original product box of another ovation ix device that was used in the same procedure.The stent graft was not returned as it was implanted in the patient as reported.The polymer kit including the auto injector was returned.The polymer syringe was returned containing approximately 5.5ml of cured polymer.There was blood residue present on the device.The delivery system was still within the sheath.The sheath was removed during decontamination.Upon initial visual inspection there is no kink in the guide wire lumen and oval fill tube.The bond between the proximal lumen spacer and hypo tube is compromised.Polymer is present at the distal end of the polyimide polymer fill line as well as the proximal pvc polymer fill tube indicating a communication along the length of the lumen.The device handles were split open, and the polymer fill line was visually inspected and was found unremarkable.The metal hypotube was dissected just proximal to the hypotube fitting and the hypotube was removed from over the internal lumens, exposing them.The polymer fill line was inspected over the entirety of its exposed length and was found unremarkable.The ability of the delivery system to deliver polymer to the graft did not appear to be compromised.The remainder of the device appears unremarkable.Unable to confirm the complaint based on the information provided and investigation performed.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the filling problem (slow polymer fill) complaint is unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness to this complaint could not be determined.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day one.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.This and similar adverse event/incident will continue to be monitored.Corrections: g3: awareness date ¿ updated h1: type of reportable event - correction h3: device evaluated by manufacturer ¿ updated h3: device returned to manufacturer for evaluation ¿ updated h6: investigation type codes ¿ remove 4117 h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• Brand Name: ALTO
• Type of Device: 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: 18329247
• MDR Text Key: 330516950
• Report Number: 3008011247-2023-00204
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)260727(10)FS072523-10
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Model Number: TV-AB2980-N
• Device Lot Number: FS072523-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION ALTO AUTO INJECTOR 2 (LN AI062923-09); OVATION IX ILIAC LIMB (LN FS062423-35); OVATION IX ILIAC LIMB (LN FS072123-30); OVATION PRIME FILL POLYMER (LN FF091923-01)
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male