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

Model Number TV-AB3480-N

Device Problems Deformation Due to Compressive Stress (2889); Device Stenosis (4066)

Patient Problems Stenosis (2263); Pseudoaneurysm (2605)

Event Date 09/29/2023

Event Type  Injury  

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately one (1) month post initial procedure, the patient presented with a "significant kink in the unsupported area of the contralateral gate of the main body".The physician plans to re-intervene by additional "stenting of [the] kinked limb" with "left common femoral artery pseudoaneurysm repair".No additional information is currently available regarding this initial report.

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 initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately one (1) month post initial procedure, the patient presented with a "significant kink in the unsupported area of the contralateral gate of the main body".The physician plans to re-intervene by additional "stenting of [the] kinked limb" with "left common femoral artery pseudoaneurysm repair".No additional information is currently available regarding this initial report.Additional information: re-intervention was completed, physician opted for implant of a bes (bioabsorbable everolimus-eluting stent), with 9x39mm on the left and 10x39mm on the right.Posterior tibial artery (pta) examination revealed no stenosis after stent placement.The left common femoral artery (lcfa) posterior superficial artery (psa) was oversewn using a continuous running suture.The final angiography demonstrated no stenosis, indicating a good flow.A comprehensive clinical evaluation was also conducted, revealing evidence indicating stenosis of the proximal left common iliac artery and the occurrence of type ii endoleak (anatomy-related), involving the lumbar and inferior mesenteric artery.The identification of these conditions transpired during a thorough examination of the computed tomography (ct) scan.The final patient status remains unknown.The final patient status was not made available to endologix.

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.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 alto pseudoaneurysm is confirmed.The kinking of the left common iliac artery stent and additional endovascular procedures were also confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest stenosis of the proximal left common iliac artery and type ii endoleak of the lumbar and inferior mesenteric artery also occurred.The left common iliac artery stenosis and type ii endoleak of the lumbar and inferior mesenteric artery were discovered during a review of the ct (computed tomography) scan.The kinked stent likely contributed to the left common iliac artery stenosis.The type ii endoleak of the lumbar artery and inferior mesenteric artery is anatomy-related.The device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status remains unknown.The final patient status was not made available to endologix.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G3: awareness date has been updated.H6: health effect - impact code - updated.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: 17946392
• MDR Text Key: 325803189
• Report Number: 3008011247-2023-00179
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)260717(10)FS071423-01
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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
• Device Operator: Health Professional
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS071423-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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 IX ILIAC LIMB, LN FS021623-12; OVATION IX ILIAC LIMB, LN FS090622-13; OVATION PRIME FILL POLYMER, LN FF040323-01
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 91 YR
• Patient Sex: Male