Model Number SB2201D |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Aneurysm (1708); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917)
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Event Date 11/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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The physician answered to the questions if images and/or the device are available with not applicable.As no device and no images are available, no further investigation can be conducted.Product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.The physician stated that the observed complications are not attributable to our gore device.
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Event Description
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The following was reported to gore: on (b)(6) 2016, the patient underwent surgical treatment for infrarenal fusiform aortic aneurysm of 54 mm confirmed by cta with a gore-tex® vascular graft.During surgery, an intraoperative hemorrhagic shock occurred with blood loss of about 3.8 l, which required a blood transfusion.Bleeding persisted so the day after a revision surgery was performed allowing evacuation of a retroperitoneal hematoma.No active bleeding has been found.The patient was put in the icu and deceased 3 days later from refractory multiple organ failure.The physician stated that the observed complications are not attributable to our gore device.
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Manufacturer Narrative
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According to the physician the gore device has not malfunctioned and the complications and/or adverse events observed as well as the later death are not attributable to our gore device.
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Manufacturer Narrative
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H1 type of reportable event should be "other".Review of new provided information from the hospital changes this event to not-reportable per our surgical vascular graft worldwide reporting guidelines, when a blood transfusion is not attributable to the gore device.According to the physician the observed complications and the death are not attributable to our gore device.It was aortic state that caused that blood loss in this patient.The aorta appeared too damaged by disease, so per-operative bleeding could not be controlled.As there is no allegation of a serious injury or malfunction of the gore-tex® stretch vascular graft in question anymore per our worldwide reporting guidelines, this event is considered not reportable.Therefore the report is being retracted.
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Search Alerts/Recalls
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