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

Model Number TV-AB2980-N

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Material Invagination (1336); Material Integrity Problem (2978)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Vomiting (2144); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/26/2022

Event Type  Death  

Manufacturer Narrative

The device remains implanted in the patient; therefore, it will not be returned for evaluation.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.Device remains implanted.

Event Description

The patient was being implanted with the alto abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Four (4) minutes after polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied and the patient experienced hypotension evidenced by a drop in blood pressure due to a suspected polymer leak.The patient was successfully treated for an anaphylactic reaction per the device ifu.The procedure was successfully completed with no endoleak.The patient was being monitored.Additional information was provided from the physician a few days later.The physician stated that the patient seemed to recover well from the anaphylactic reaction.However, when attempting to extubate the patient, the patient aspirated (while vomiting) and required to be reintubated.On sunday or monday (january 30 or 31), a new ct (computed tomography) scan was taken.The ct showed that the aortic body was occluded.Early monday morning, (b)(6) 2022, the patient was taken back to the operating room.The physician preformed a bi-lateral open femoral artery exposure.The physician removed thrombus from both limbs and the aortic body as it appears to be occluded.The physician stated that the proximal rings of the stent graft seemed to be enfolded.The physician ballooned the rings and they seemed to open well.Flow was noted to be good.The physician started to patch the femoral artery before closing the contralateral side.At this point, the patient spontaneously coded.Attempts to revive the patient were made.Unfortunately, the patient passed on monday ((b)(6) 2022) morning.

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 report as not being available to be returned to endologix for an evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix was unable to confirm the reported hypotension caused by a possible polymer leak, polymer ring in-folding or the additional endovascular procedure.The aortic occlusion that occurred 5 days post the initial procedure was confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The procedure related harms identified were the aortic occlusion.It was reported the patient recovered well from the hypotension caused by a possible polymer leak but aspirated during extubation requiring re-intervention the evening of the index procedure.The patient was reported to have passed away on (b)(6) 2022.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.

• 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: 13527671
• MDR Text Key: 285600411
• Report Number: 3008011247-2022-00009
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)241203(10)FS113021-11
• 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: 01/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB2980-N
• Device Lot Number: FS113021-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• 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: FILL POLYMER, LOT FF081621-02; OVATION IX, ILIAC LIMB, LOT FS112421-39; OVATION IX, ILIAC LIMB, LOT FS113021-05
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Male