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

Model Number TV-AB2680-N

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the 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 implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that the patient has a history of cardiac rupture which was the result of a cardiac infarction in (b)(6) 2023 which required a surgical procedure at the time and a pericardial patch was used.There was no treatment done on the coronary arteries.It was reported that prior to the alto procedure, the right internal iliac, superior and inferior gluteal arteries were occluded by coils.The inferior mesenteric artery (ima) and a lumbar artery were also occluded.This part of the procedure took five (5) hours.The alto main body was inserted via the left access and deployed and the polymer was injected.The patient's blood pressure was normal at this point.The contralateral gate cannulation was not completed after 14 minutes; therefore, ballooning was done first.The contralateral gate was successfully cannulated after the ballooning, and an ovation ix iliac limb was implanted.An additional ovation ix iliac limb was added and at this point the anesthesiologist pointed out there was blood pressure drop of approximately around 50bpm.There were no procedure related complications, therefore the blood pressure drop was controlled with administration of adrenarin which was at 20 minutes after polymer injection.After the alto main body delivery system was removed an third ovation ix iliac limb was inserted and just before deployment, the blood pressure suddenly decreased resulting in a cardiac arrest.Chest compressions and were performed.The cardiac rhythm was maintained, however, ventricular fibrillation (vf) occurred again.Emergency care was performed again and the cardiac rhythm was restored.The iliac limb was deployed.The cardiac rhthm remained stable after that.Balooning was performed and a 10x10 cm (non-endologix) bare metal stent was in the right distal limb portion.No endoleak was observed on the last angiogram and the endovascular procedure was completed.A coronary artery angiography (cag) was performed and no abnormality was observed.The cause of the blood pressure drop was not identified.

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 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 intraoperative cardiac arrest 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.Procedure related harms for this complaint could not be determined.It was reported that the procedure lasted longer than five hours.It was reported that the patient had history of a ruptured myocardium treated with a pericardial patch following a myocardial infarction in (b)(6) of 2023 (within 6 months of procedure-cautionary product use).This was an off-label case there was no abdominal aortic aneurysm sac and the right common iliac artery diameter was 44mm (should be 8-25mm).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: b2: outcomes attributed to adverse events has been updated g3: awareness date has been updated, h6: medical device problem codes: remove code 2993, 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: 18970864
• MDR Text Key: 338510474
• Report Number: 3008011247-2024-00032
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)260317(10)FS031623-02
• 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,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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-AB2680-N
• Device Lot Number: FS031623-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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: BMS 10X10CM (NON-ENDOLOGIX); COILS (NON-ENDOLOGIX); OVATION IX ILIAC LIMB, LOT # FS032123-17; OVATION IX ILIAC LIMB, LOT # FS061523-05; OVATION IX ILIAC LIMB, LOT # FS062123-01; OVATION PRIME FILL POLYMER, LOT # FF081523-01
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 63 YR
• Patient Sex: Female