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

Model Number TV-AB3480-N

Device Problems Deflation Problem (1149); Filling Problem (1233); Inflation Problem (1310)

Patient Problem Failure of Implant (1924)

Event Date 09/29/2023

Event Type  Injury  

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2023 with the implant of an alto stent graft system.The alto delivery system was inserted from the right femoral artery, and the mid-crown was deployed.The physician attempted to inflate the integrated balloon, but the contrast solution was injecting smoothly, and the balloon did not inflate as expected.The physician pushed the syringe strongly to inflate the balloon, and the distal portion of mid-crown expanded.The balloon deflation was also difficult, and it took longer than expected to deflate.The physician injected the polymer, but the contralateral limb did not fill.The alto main body was slightly pushed upward, and the polymer was slightly filled into the contralateral limb.The integrated balloon was again inflated for ballooning the sealing ring but would not completely inflate up to the maximum volume (19cc).The balloon was deflated with some difficulty again.Angiography was performed.There was no endoleak identified.The contralateral and ipsilateral ovation ix iliac limbs were implanted.The final angiogram showed no endoleaks and the operation was completed.The patient was reported to be stable.

Manufacturer Narrative

The device involved in this event has been received; however, the device evaluation has not yet begun.The available patient medical records and imaging studies have been received.A follow-up report will be submitted upon completion of the device evaluation and the clinical analysis.

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.Endologix performed an evaluation of the returned alto delivery system.The device was received in a large shipping box, within three clear plastic bags and wrapped in bubble wrap.A 30ml syringe containing 4ml of cured polymer was returned still attached to the delivery system.The syringe was removed during decontamination.The delivery system was still within the sheath.The stent graft was not returned as it was reportedly implanted in the patient.There was blood residue present on the device.There was a kink at the base of the flush tube of the sheath and the tube was filled with blood.The sheath was removed during decontamination.A visual and limited functional analysis were performed.Upon initial visual inspection the oval balloon fill tube exhibited a double kink at 5mm and 7mm proximal to the proximal lumen spacer in a "z" bend configuration.There are singe kinks at 18mm and 22mm in the oval fill tube proximal to the proximal lumen spacer.There were no kinks in the guide wire lumen.The bond between the guide wire lumen and the proximal lumen spacer is compromised and the guide wire lumen can slide freely within the lumen spacer.Additionally, the bond between the lumen spacer and the hypo tube was also compromised.For reference, the device presented with the distal side of the distal stop fitting to proximal edge of the proximal lumen spacer at 10.5mm.A functional analysis was performed where a 30ml syringe filled with 30ml tap water was connected to the balloon fill port.When the device was held in a straight configuration, with a stiff wire through the guide wire lumen, the balloon was able be inflated with significant resistance but not able to be aspirated.When the oval fill lumen was placed on an inner curve, the balloon was unable to be filled or aspirated.The remainder of the device is unremarkable.The complaint is confirmed.A clinical evaluation of the adverse event/incident was completed.An examination of hand drawn pre-planning imaging received by endologix cannot confirm the reported balloon inflation issue, balloon deflation issue and no fill complaints.However, the return device analysis is consistent with the reported device malfunction.The most likely causation for the reported balloon inflation issue, balloon deflation issue and no fill cannot be determined.Due to the absence of relative medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as no clinical harm from this event.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 event/incident.B5: describe event or problem - updated g3: awareness date ¿ updated h3: device evaluated by manufacturer - updated h6: investigation type codes ¿ remove code 4118 h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2023 with the implant of an alto stent graft system.The alto delivery system was inserted from the right femoral artery, and the mid-crown was deployed.The physician attempted to inflate the integrated balloon, but the contrast solution was not injecting smoothly, and the balloon did not inflate as expected.The physician pushed the syringe strongly to inflate the balloon, and the distal portion of mid-crown expanded.The balloon deflation was also difficult, and it took longer than expected to deflate.The physician injected the polymer, but the contralateral limb did not fill.The alto main body was slightly pushed upward, and the polymer was slightly filled into the contralateral limb.The integrated balloon was again inflated for ballooning the sealing ring but would not completely inflate up to the maximum volume (19cc).The balloon was deflated with some difficulty again.Angiography was performed.There was no endoleak identified.The contralateral and ipsilateral ovation ix iliac limbs were implanted.The final angiogram showed no endoleaks and the operation was completed.The patient was reported to be stable.

• 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: 18024837
• MDR Text Key: 326795654
• Report Number: 3008011247-2023-00182
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)260712(10)FS071023-68
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Lot Number: FS071023-68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2023
• 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 #FS102722-45.; OVATION IX ILIAC LIMB, LOT #FS110122-06.; OVATION PRIME FILL POLYMER, LOT #FF100322-03.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male