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

Model Number TV-AB3480-N

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 06/22/2022

Event Type  Injury  

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.The alto main body was deployed.The integrated balloon was used at 14 minutes and ruptured with approximately 17ml injected.This caused a type ia endoleak.A palmaz (non-endologix) stent was deployed sealing the type ia endoleak.The patient did well.

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation as the alto main body delivery system was discarded by the hospital.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.Device discarded by hospital.

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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the alto stent graft delivery system was discarded at the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows intraoperative balloon rupture is unconfirmed.The intraoperative type ia endoleak resolved with a palmaz stent is confirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.It should be noted that the type ia endoleak could have been related to the reported integrated balloon rupture; however, due to the lack of intraoperative imaging on the angiogram that demonstrated the use of the integrated balloon a definitive root cause cannot be determined.The type ia endoleak was completely resolved with the palmaz stent.The final patient status was reported as being 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.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 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: 14896260
• MDR Text Key: 295227662
• Report Number: 3008011247-2022-00069
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)250128(10)FS012622-35
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS012622-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 FS020322-32); OVATION IX ILIAC LIMB (LN FS032822-62); OVATION PRIME FILL POLYMER (LN FF072021-02)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR