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

Model Number TV-AB3480-N

Device Problem Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 03/15/2022

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.Delivery system discarded.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, the integrated balloon ruptured.At the conclusion of the procedure, the patient was noted to have lost a significant volume of blood.The physician performed an angiogram and observed a slight tear in the aorta.Patient was then converted to open repair and a patch was sewn in the torn area.The procedure was completed and the patient is in recovery and doing well.The delivery system is not available for return/evaluation.

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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it was discarded.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 integrated balloon rupture, reported blood loss and surgical conversion are unconfirmed.The aortic neck dissection is confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for this event is user related.Per the ifu, the integrated balloon maximum inflation volume for a 34mm aortic body should be 19ml.The physician inflated with 20ml, which could have lead to the aortic neck dissection.The procedure related harm identified was renal failure.The last patient status reported to be in the recovery room doing 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.Corrections: h6: component codes: remove code 515.H6: investigation finding: remove code 3233.H6: investigation conclusion: 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: 13845846
• MDR Text Key: 287599069
• Report Number: 3008011247-2022-00024
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)250105(10)FS010422-03
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• 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: FS010422-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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, SN (B)(6); OVATION IX ILIAC LIMB, SN (B)(6); OVATION PRIME FILL POLYMER, SN (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male