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

Model Number TV-AB3480-N

Device Problems Positioning Failure (1158); Difficult to Fold, Unfold or Collapse (1254); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

The patient was being implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that when 19 cc of fluid was injected to inflate the balloon as part of the stent implant procedure, the balloon burst.Additionally, attempts to cannulate the contralateral gate were unsuccessful.The physician decided to snare a 0.014'' x 300 cm length wire which was successful to cannulate the contralateral gate; however, upon withdrawal this caused the main body limbs to cross over each other.The physician attempted to straighten out the limbs with kissing (12x4 non-endologix) balloons.This gave some relief but the appearance of the limbs was still crossed.The procedure was continued and iliac limbs were deployed and it was determined to add kissing viabahn (non-endologix) stents above the half rings of the main body to prevent occlusion/kinking.No further information was provided.

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.The delivery system was discarded.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.

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 as it was discarded and the stent graft remains implanted; therefore no evaluation was completed.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 the alto delivery system, integrated balloon rupture is unconfirmed.The difficult to cannulate the contralateral gate and crossed limbs (twisting) are confirmed.This is moderately consistent with the reported adverse event/incident.There was concomitant product usage of non endologix stents in the right and left common iliac arteries.It is unclear if this off label use condition contributed to the reported event.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day one.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.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: 16992492
• MDR Text Key: 315843661
• Report Number: 3008011247-2023-00061
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)251006(10)FS100522-05
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB3480-N
• Device Catalogue Number: TV-AB3480-N
• Device Lot Number: FS100522-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• 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: OVATION IX ILIAC LIMB, LOT # FS062322-77.; OVATION IX ILIAC LIMB, LOT # FS072122-32.; OVATION PRIME FILL POLYMER, FF120722-04.; VIABAHN STENTS (NON-ENDOLOGIX), LOT # UNKNOWN.
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male