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Catalog Number PAC081002 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Death (1802); Pneumonia (2011); Respiratory Distress (2045); Septic Shock (2068); Paraplegia (2448)
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Event Date 12/06/2011 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: pxt311413/8829797, pxc181200/9500022, pxc201400/7799837, pxt231216/9472086, pac061002/9047052, pac061002/9047047, pac061002/9018650, pac071002/8896681, pac071002/8896667, pac081002/9146745, pac081002/9179022, pac061002/9179024.(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.
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Event Description
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On (b)(6) 2011, a patient underwent endovascular treatment for a thoracoabdominal aneurysm measuring 54.5mm in diameter and was implanted with goreexcluderaaa endoprostheses in zone 4 of the distal descending thoracic aorta.Nine gore viabahnendoprosthesis with heparin bioactive surface were also implanted ending up in the renal arteries, celiac trunk and superior mesenteric artery.The technique used for this patient was a "tandem-of-the-shelf" technique.The procedure performed was not exactly the same but it was similar.An excluder bifurcated device was placed on the thoracic aorta of the patient and through the contralateral limb the viabahn devices were advanced to the left renal artery, celiac trunk and superior mesenteric artery.Through the long limb of the excluder, a viabahn was inserted for the right renal artery and a excluder extension for the abdominal aorta.Inside of this excluder extension, another excluder bifurcated was inserted, with the long limb finishing at left common iliac artery and the contralateral limb was placed at the right common iliac artery in the distal third.Almost all the extension of the thoracoabdominal aorta was covered including the exclusion of the distal thoracic arteries, all lumbar arteries and the inferior mesenteric artery.The patient tolerated the procedure, however, it was reported that the same day the patient experienced paraplegy and developed pneumonia.The patient expired on (b)(6) 2011.The cause of death was septic shock due to pneumonia.The patient woke up from anesthesia the first day after the surgery and had abdominal distention with respiratory distress, and needed to be re-intubated.He developed pneumonia and septic shock and died 6 days from the procedure date.
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Manufacturer Narrative
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The gore® viabahn® endoprostheses used in this procedure did not have the heparin bioactive surface as stated in the initial medwatch.
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Search Alerts/Recalls
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