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

Model Number TV-AB2680-N

Device Problem Material Rupture (1546)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto abdominal stent graft system.Post alto main body deployment the integrated balloon was used to balloon in the polymer rings.The balloon ruptured with only 5 ml of solution in it.There were no clinical or procedural issues as a result.The case went fine and patient was successfully repaired.Note: the device did not contribute to death or serious injury but could have based on a similar event(s) with the same failure mode occurring within the last two (2) years that did cause or contribute to death or serious injury of the patient and/or user.

Manufacturer Narrative

The device involved in this event has been received; however, the device evaluation has not yet begun.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.

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 returned endologix alto abdominal stent graft delivery system was completed.The device was received in a large shipping box, within two biohazard bags.The device was returned in a curved configuration and the hypotube was kinked at a 90 degree angle at approximately 240mm from the base of the handle.There was blood residue present on the device.There was also blood residue visible within the balloon tubing and within the balloon.The balloon was visibly torn.The stent graft was not returned as it was implanted in the patient.The sheath was not returned.Upon visual inspection there are kinks present in the guidewire lumen, oval balloon lumen at approximately 19mm and in the polymer fill line at 10mm proximal to the proximal lumen spacer.The hypotube presented with a large "s" shaped bend as well as a kink in the hypotube where the laser cut slit begin.The balloon presented with a half circumferential tear around the area of the proximal shoulder of the balloon.The remainder of the device is unremarkable.Based on the evaluation performed the complaint is confirmed.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and or medical imaging received by endologix was performed.Based on the operative note and return device evaluation the reported balloon rupture of the alto abdominal stent graft delivery system integrated balloon is confirmed.These findings are consistent with 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 to be discharged to home on postoperative day seven.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.G3: awareness date ¿ updated.H3: device evaluated by manufacturer - updated.H6: investigation type codes - remove 4117.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: ALTO
• Type of Device: MAIN BODY DELIVERY SYSTEM
• 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: 16062440
• MDR Text Key: 306413073
• Report Number: 3008011247-2022-00167
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB2680-N
• Device Lot Number: FS100622-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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 PRIME FILL POLYMER (LN FF052322-01)
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Male