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

Model Number TV-AB3480-N

Device Problems Filling Problem (1233); Off-Label Use (1494)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.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 patient was being treated for an endovascular aneurysm repair (evar) on (b)(6) 2024.The inferior mesenteric artery and right internal iliac artery (iia) had been occluded beforehand.The left iia and three lumbar arteries were occluded at the beginning of evar.The alto abdominal aortic aneurysm stent graft delivery system was inserted from the right access with consideration of the vessel condition, and it was deployed.The polymer was then injected.Polymer fill was confirmed on some rings of the ipsilateral limb, but the polymer did not go above that.The physician slightly pushed the system, but it did not help.A stiff wire was advanced again to make the system straight, but it did not help, either.There was no kink observed on the polymer port.There was no abnormality on the injector.Under fluoroscopy, the polymer lumen of ipsilateral side appeared to be kinked, so the delivery system was slightly pulled to try to make it straight; but it did not help.The polymer injection was at five minutes.As any trouble shootings did not work, the physician decided to continue the procedure.He tried to cannulate the contralateral gate through the cross over lumen, but it did not work, so the wire was inserted from the ipsilateral side (not using the cross over lumen) and delivered to the contralateral side passing inside the graft.Limbs were then implanted on both sides.A type ia endoleak was observed, and a gore (non-endologix) cuff graft was added.The type ia endoleak was resolved, the operation was completed.

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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.Endologix performed an evaluation of the returned alto delivery system.The device was shipped in a large shipping box along with another device.The auto injector was returned still attached to the polymer syringe which had 9ml of cured polymer and was still attached to the delivery system.There was blood residue present on the device.The stent graft was not returned as it was implanted in the patient as reported.The device was still within the sheath.The sheath was removed during decontamination.A visual and limited functional analysis was performed.Upon visual inspection there is a kink in the guide wire lumen approximately 1.5mm proximal to the proximal lumen spacer.The ptfe section of the crossover lumen just distal to the end of the inner support lumen is slightly accordioned for approximately 6mm.A 0.035" guide wire was inserted into the delivery system guide wire lumen.The proximal lumen spacer to hupotube bond is compromised, yet the guide wire lumen to proximal lumen spacer bond is intact.There is a kink in the laser cut section of the hypotube just proximal to the start of the laser cuts adjacent to the stiff section of the tube.The delivery system handle halves were separated, and the inner chassis was inspected.There were no abnormalities noted in the polymer delivery handle assembly.The remainder of the device is unremarkable.There is polymer present throughout the length of the polymer fill tube.The auto injector was inspected and appeared to function as expected.Based on the information provided and the analysis performed, endologix was unable to confirm the complaint.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 filling problem (fill channels/ incomplete fill of the polymer rings) as well as the type ia endoleak (resolved) complaint is confirmed.This is consistent with the reported adverse event/incident.The right common iliac maximum diameter was 39mm and the left common iliac maximum diameter was 30 mm (should be 8-25 mm); therefore, this is classified as an off-label case.It is unlikely that the off-label nature of this case contributed to the reported events.It is unclear why there was incomplete fill of the polymer rings.The incomplete fill of the polymer rings likely caused the reported type ia endoleak.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The final patient status was not reported.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: d9: device available for evaluation - updated.G3: awareness date ¿ updated.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: 18989922
• MDR Text Key: 338746343
• Report Number: 3008011247-2024-00035
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 0085000730916
• UDI-Public: (01)0085000730916(17)261114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS110923-47
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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: GORE (NON-ENDOLOGIX) CUFF (LN UNK); OVATION IX EXTENDER (LN FS092822-09); OVATION IX FILL POLYMER (LN FF081523-01); OVATION IX ILIAC LIMB (LN FS030123-17); OVATION IX ILIAC LIMB (LN FS042823-24); OVATION IX ILIAC LIMB (LN FS050223-05)
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male