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

Model Number TV-AB2380-N

Device Problem Filling Problem (1233)

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

Event Date 01/17/2024

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.H3 other text : device remains implanted.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal stent graft system.The alto main body was deployed and during polymer fill the contralateral limb did not fill.The lumen was adequate but there was a sharp turn at ir 40 where the fill line appeared to stop.The physician withdrew the lunderquist (non-endologix) guidewire and that did nothing.The physician performed light inflation at 5cc.This adjusted the graft and moved the fill line but not enough to fill the limb.Inflation of 2 more cc was added.The fill line immediately straightened, and the contralateral limb filled.This was four minutes into the fourteen-minute fill time.The procedure was completed with the implant of two additional ovation ix iliac limbs and one ovation i x extender.No patient harm was reported.

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 could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the intraoperative filling problem of the contralateral limb complaint is unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were identified.The final patient status was reported as discharged to 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.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: g3: awareness date ¿ 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: 18686303
• MDR Text Key: 336208319
• Report Number: 3008011247-2024-00015
• Device Sequence Number: 1
• Product Code: MIH
• 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: 01/17/2024

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-AB2380-N
• Device Lot Number: FS110923-74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• 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 EXTENDER (LN FS042022-43); OVATION IX ILIAC LIMB (LN FS042821-47); OVATION IX ILIAC LIMB (LN FS080423-46); OVATION IX ILIAC LIMB (LN FS081523-30); OVATION IX ILIAC LIMB (LN FS101722-42); OVATION PRIME FILL POLYMER (LN FF101623-01)
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female