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 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Endologix received one (1) alto delivery system for an evaluation.The device was shipped in a biohazard bag within a small shipping pouch.Blood residue was present upon receipt and within the balloon fill line.The sheath was not returned.The delivery system was severely bent in two (2) locations to fit in the shipping pouch.The stent graft was not returned as it was implanted in the patient as reported.Upon visual inspection there was a kink in the polymer fill line at approximately 9.5mm proximal to the proximal lumen spacer.There were kinks in the oval balloon line 2, 8, 13mm proximal to the proximal lumen spacer.There was an almost complete separation of the guide wire lumen at approximately 7mm proximal to the proximal lumen spacer.The balloon is torn approximately 180 degrees around the circumference of the proximal balloon shoulder where the taper meets the working diameter.Upon inspection of the balloon shoulder marker bands both proximal and distal markers appeared to be lacking the required adhesive fillet to the guide wire lumen and had exposed sharp edges.The proximal balloon leg was invaginated proximally over itself leaving approximately 1mm of the balloon leg exposed.There is a severe kink in the laser cut hypo tube where the laser cut ends and the solid section of the hypo tube begins likely due to shipping.There appears to be blood residue present within both the balloon and the oval balloon fill tube all the way back to the balloon fill line at the rear of the handle.The end of the cross over lumen appears to be forked in two (2) starting at the retention wire hole to the end of the skive.The remainder of the device appears unremarkable.The reported balloon rupture is confirmed; however, clinical analysis of the reported event has not yet been completed to determine the most likely cause.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A follow-up report will be submitted subsequent to the completion of the clinical analysis.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.After the 14 minute cure time, the integral balloon ruptured while ballooning the sealing ring.There was no harm to the patient, and the procedure was completed.The patient was reported to be doing well and discharged one-day post-procedure.

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 received one (1) alto delivery system for an evaluation.The device was shipped in a biohazard bag within a small shipping pouch.Blood residue was present upon receipt and within the balloon fill line.The delivery system was severely bent in two (2) locations to fit in the shipping pouch.The stent graft was not returned as it was implanted in the patient as reported.An evaluation of the returned device was completed.A visual and limited functional analysis were performed.Upon visual inspection there was a kink in the polymer fill line and the oval balloon line.There was also complete separation of the guide wire lumen to the proximal lumen spacer.The balloon was torn approximately 180 degrees around the circumference of the proximal balloon shoulder where the taper meets the working diameter.Upon inspection of the balloon shoulder marker bands, both proximal and distal markers appeared to be lacking the required adhesive fillet to the guide wire lumen and had exposed sharp edges.The proximal balloon leg was invaginated proximally over itself leaving approximately 1mm of the balloon leg exposed.There was a severe kink in the laser cut hypo tube where the laser cut ends and the solid section of the hypo tube begins likely due to shipping.There appeared to be blood residue present within both the balloon and the oval balloon fill tube all the way back to the balloon fill line at the rear of the handle.The end of the cross over lumen appeared to be forked in two (2) starting at the retention wire hole to the end of the skive.The reported balloon rupture was confirmed 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 integrated alto balloon rupture.This is consistent with the reported adverse event/incident.The balloon rupture is most likely device related due to the kinks in the polymer fill line and oval balloon line.Also the balloon was torn and there appeared to be no adhesive to the guide wire lumen which had exposed sharp edges that was identified during the device evaluation.No procedure related harms were identified.The final patient status was discharged home on the first 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: d2: common device name has been updated g3: date of received by manufacturer has been updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion code: remove code 11.

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 device was completed.A visual analysis was performed.The analysis of the returned device shows blood residue present upon receipt and within the balloon fill line.The delivery system was severely bent in two (2) locations to fit in the shipping pouch.The stent graft was not returned as it was implanted in the patient as reported.Upon visual inspection there was a kink in the polymer fill line and the oval balloon line.There was also complete separation of the guide wire lumen to the proximal lumen spacer.The balloon was torn approximately 180 degrees around the circumference of the proximal balloon shoulder where the taper meets the working diameter.Upon inspection of the balloon shoulder marker bands, both proximal and distal markers appeared to be lacking the required adhesive fillet to the guide wire lumen and had exposed sharp edges.The proximal balloon leg was invaginated proximally over itself leaving approximately 1mm of the balloon leg exposed.There was a severe kink in the laser cut hypo tube where the laser cut ends and the solid section of the hypo tube begins likely due to shipping.There appeared to be blood residue present within both the balloon and the oval balloon fill tube all the way back to the balloon fill line at the rear of the handle.The end of the cross over lumen appeared to be forked in two (2) starting at the retention wire hole to the end of the skive.This is consistent with the reported adverse event/incident.A clinical evaluation of the incident was completed.An examination of medical records and/or medical imaging received by endologix shows that there was successful placement of the alto main body and ovation ix iliac limbs with no adverse events to the patient.This is consistent with the reported incident.Procedure related harms, device, user, procedure or anatomy relatedness of this incident could not be determined with the medical records available for review.The final patient status was discharged home on the first post operative day in stable condition.No additional investigation of this reported 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 incidents.Corrections: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 170.H6: investigation conclusion codes - remove code 4307.H10/h11: additional manufacturer narrative/corrected data - updated.

• 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: 14043584
• MDR Text Key: 288803041
• Report Number: 3008011247-2022-00030
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)241129(10)FS112221-63
• 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,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: FS112221-63
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• 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 (LN FS050321-07); OVATION IX ILIAC LIMB (LN FS121421-58); OVATION PRIME FILL POLYMER (LN FF070121-03)
• Patient Age: 78 YR
• Patient Sex: Male