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

Model Number	TV-AB2080-N
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Rash (2033); Obstruction/Occlusion (2422)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was being implanted with the alto abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).During 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 and a rash appears all over the body due to a suspected polymer leak.The patient was treated for an anaphylactic reaction per the device ifu and was stabilized within approximately 12 minutes.It was noted that the main body limbs appeared crossed causing difficultly to cannulate the contra limb.The procedure was completed.The next morning, it was reported that the right limb had became occluded from two (2) cm above the iliac bifurcation of the main body to the common femoral.A femoral ¿ femoral bypass was performed to restore flow.The procedure was completed with good seal.The patient was reported as doing fine and discharged the next day.
Additional 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 as 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 was able to confirm the reported polymer leak with body rash and hypotension, right common femoral artery occlusion, and an additional surgical procedure (fem-fem bypass).This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to an inability to cannulate the contralateral limb necessitating a brachial cutdown.These findings were discovered during an examination of operative notes dated (b)(6)2022.Device, user, procedure or anatomy relatedness of the polymer leak and occlusion of the right common femoral artery complaints could not be determined.The procedure related harms identified were the additional surgical procedure and right common femoral artery occlusion.The following additional information was identified during the clinical evaluation; it was reported the limbs appeared to sit on top of each other and the graft appeared twisted.On imaging, it did appear the limbs could be stacked on each other with the right limb possibly posterior to the left.There was decreased contrast flow that was delayed in the right limb on the final angiogram run during the evar procedure.It was reported that the contralateral limb cannulation was difficult due to the configuration and possible twisting of the limbs.This was despite the orientation markers being set correctly.However, it is unclear to what extent the possible twisting and stacking of the proximal limbs contributed to the reported event.The operative note stated he suspected plaque at origin of superficial femoral artery resulted in thrombosis given the profound hypotension that occurred with the polymer leak.The final patient status was discharged on the second post operative day in stable condition.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: b5: describe event or problem has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion code: remove code 11.
Event or Problem Description
The patient was being implanted with the alto abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).During 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 and a rash appears all over the body due to a suspected polymer leak.The patient was treated for an anaphylactic reaction per the device ifu and was stabilized within approximately 12 minutes.It was noted that the main body limbs appeared crossed causing difficultly to cannulate the contra limb.The procedure was completed.The next morning, it was reported that the right limb had became occluded from two (2) cm above the iliac bifurcation of the main body to the common femoral.A femoral ¿ femoral bypass was performed to restore flow.The procedure was completed with good seal.The patient was reported as doing fine and discharged the next day.Additional information: during the clinical evaluation, an inability to cannulate the contralateral limb necessitating a brachial cutdown was identified.These findings were discovered during an examination of operative notes dated 26apr2022.

• Brand Name: ALTO
• Common Device Name: 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: 14341316
• Report Number: 3008011247-2022-00043
• Device Sequence Number: 12343029
• Product Code: MIH
• UDI-Device Identifier: 00850007370381
• UDI-Public: (01)00850007370381(17)250202(10)FS013122-03
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2025
• Device Model Number: TV-AB2080-N
• Device Lot Number: FS013122-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FILL POLYMER, LOT FF080621-01.; OVATION IX, ILIAC LIMB, LOT FS022322-02.; OVATION IX, ILIAC LIMB, LOT FS031522-32.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female