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

Model Number TV-AB3480-N

Device Problems Complete Blockage (1094); Retraction Problem (1536); Short Fill (1575)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient was being implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that during deployment of the main body, there was a problem with retraction of the delivery system sheath.After the stent graft was implanted, the polymer was unable to be injected upon the first attempt.The had to insert a 0.018 inch wire in the polymer port; however, the wire would not advance any more proximal than one (1) cm.The decision was made to open another polymer kit and hand inject the polymer enough to get the polymer rings to barely fill.Then used up and over wire to access the contralateral side since no ring was visible on contralateral limb.There was no patient injury reported.The delivery system was returned and its evaluation is pending.

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 was completed.The stent graft was not returned to endologix for evaluation because it remains implanted.Endologix received one (1) alto delivery system for an evaluation.The device was shipped in a large shipping box, within a biohazard bag, within the original product box.The stent graft was not returned as it was implanted in the patient as reported.The delivery system was still within the sheath.The sheath was removed during decontamination.A 30ml syringe containing 6.5ml of cured polymer was returned.Two auto injectors and two polymer kits were returned.The polymer kits each had one 30ml syringe still attached and containing 2ml of fluid.There was blood residue present on all the returned devices.A visual and limited functional analysis were performed.Upon initial visual inspection there appears to be a kink in the guide wire lumen at 2.5 mm proximal to the proximal lumen spacer.There are kinks in the oval balloon fill lumen at 1.4 and 7 mm proximal to the proximal lumen spacer.The remainder of the delivery system appears unremarkable.Upon inspection of the rear end of the delivery system, there appears to be cured polymer present in the pvc polymer fill line and double y connector fittings.The device was dissected proximal to the hypotube fitting through the metal hypotube and inner lumens.The proximal lumen spacer was manually separated from the hypotube and all inner lumens were removed from hypotube as a subassembly.Through microscopic visualization was able to confirm the presence of cured polymer throughout the length of the polyimide polymer fill line.No obstructions, kinks, or other foreign material were visualized.There is nothing apparent from the device investigation which would explain a no, or slow fill situation.The auto injectors seem to be functional.The polymer fill kits appear as expected for a 34 mm device preparation.Based on the information provided and the investigation performed it was not possible to confirm the complaint.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 delivery system, device damage during use, difficult to retract the sheath, and obstruction within the device complaints are unconfirmed.The polymer filling problems (incomplete fill) complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the complaint could not be determined.The initial procedure is outside the ifu due to concomitant device usage of a gore (non-endologix) iliac branch endoprosthesis (ibe) in the left common iliac artery and a vbx stent in the left internal iliac artery.It is unlikely this contributed to the reported events.Procedure related harms for this complaint are acute kidney injury and right lower extremity embolism requiring additional endovascular procedure (right groin cutdown with thrombectomy).The final patient status was reported as discharged home on postoperative day six with home health.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: 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: 18278720
• MDR Text Key: 330817196
• Report Number: 3008011247-2023-00197
• 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: 11/10/2023

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: FS080923-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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 # FS080823-23.; OVATION IX ILIAC LIMB, LOT # FS092622-14.; OVATION IX ILIAC LIMB, LOT # FS111522-18.; OVATION PRIME FILL POLYMER, LOT # FF051223-02.; OVATION PRIME FILL POLYMER, LOT # FF052623-01.
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male