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

Model Number TV-AB3480-L

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problems Anaphylactic Shock (1703); Failure of Implant (1924); Pain (1994)

Event Date 07/04/2023

Event Type  Injury  

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, a polymer leak occurred; the stent-graft adequately filled but the remaining polymer flowed into the patient, whom then experienced anaphylaxis.The physician administered medication, however the patient complained of severe lumbar pain post procedure.

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.H3 other text : devices remain implanted.

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 could not be completed.No medical records or medical imaging relevant to the adverse event/incident was received by endologix.Due to the absence of relevant medical records and reported medical imaging, the device, use, procedure and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as experiencing lumbar pain post index procedure.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: d10 concomitant products.G3 awareness date.H6 medical device problem codes; remove 2978.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 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: 17505280
• MDR Text Key: 320862868
• Report Number: 3008011247-2023-00153
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370961
• UDI-Public: (01)00850007370961(17)250808(10)FS080422-62
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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-AB3480-L
• Device Lot Number: FS080422-62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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 (LEFT), LN UNKNOWN; OVATION IX ILIAC LIMB (RIGHT), LN UNKNOWN; OVATION IX ILIAC LIMB, LN FS090822-44; OVATION IX ILIAC LIMB, LN FS102822-21; OVATION PRIME FILL POLYMER, LN FF062122-02; OVATION PRIME FILL POLYMER, LN FF092222-03; OVATION PRIME POLYMER FILL, LN UNKNOWN
• Patient Outcome(s): Required Intervention