Model Number I16-16/C88 SA |
Device Problems
Complete Blockage (1094); Obstruction of Flow (2423)
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Patient Problems
Rupture (2208); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 12/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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The devices involved in this event will not be returned for evaluation and remain implanted in the patient.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.Device iteration is afx with duraply.
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Event Description
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The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx limb stent graft distal extension and two (2) ovation ix extenders.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx2 system per device ifu.Ten (10) days post initial procedure, the patient presented with a blood clot in the right leg.During removal of the clot, the physician ruptured the right external iliac, which the physician subsequently covered with an ovation ix iliac limb.The patient is reportedly doing well.
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Event Description
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The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx limb stent graft distal extension and two (2) ovation ix extenders.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx2 system per device ifu.Ten (10) days post initial procedure, the patient presented with a blood clot in the right leg.During removal of the clot, the physician ruptured the right external iliac, which the physician subsequently covered with an ovation ix iliac limb.The patient is reportedly doing well.Additional information: clinical assessment identified that a right iliac artery occlusion also occurred.
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Manufacturer Narrative
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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 to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported afx thrombus (of the right common iliac artery), rupture (of the right external iliac artery) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a right iliac artery occlusion occurred that was not included in the event as reported.This finding was discovered during an examination of the operative report dated 12 december 2022 and discharge summary dated 14 december 2022.No procedure-related harms of this event were identified.The most likely causation for the reported event is user-related.It was noted that the initial procedure was outside the indications of use (off-label) due to adjunctive devices (ovation ix left limb extensions) not compatible with the afx2 system per device ifu; however, it is unlikely this contributed to the reported event.In addition, the minimum right access diameter measured 5.8mm and the minimum left access diameter measured 5.2mm (ifu requirement is greater than 6.5mm); this off-label condition could have contributed to the reported event, however that could not be conclusively determined.It was also noted there was an absence of an abdominal aortic aneurysm (aaa), and patient had severe aortoiliac occlusive disease with thickened calcifications; these off-label conditions likely contributed to the reported event.The final patient status was reported as discharged home on postoperative day two.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.Device iteration is afx with duraply.Corrections: b5 describe event or problem g3 awareness date h6 investigation finding codes; remove 3233 h6 investigation finding codes; remove 11.
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Search Alerts/Recalls
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