Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: hgb161207a/18135919- udi: (b)(4), hgb161207a/18135917 - udi: (b)(4).Concomitant: patient medications include but are not limited to: acetaminophen 650 mg oral tablet, extended release, 1-2 tab(s), oral, q8hr (interval), prn, aspirin, 81 mg, oral, daily, gabapentin 300 mg oral capsule, 300 mg= 1 cap(s), oral, hs, 3 refills, ibuprofen 200 mg oral tablet, 400 mg= 2 tab(s), oral, q8hr (interval), lisinopril 5 mg oral tablet, 1 tab(s), oral, daily, 11 refills,magnesium citrate 1.745 g/30 ml oral liquid, 8.725 gm= 150 ml, oral, neurontin 100 mg oral capsule, 100 mg= 1 cap(s), oral, tid, 11 refills, pravastatin 20 mg oral tablet, 20 mg= 1 tab(s), oral, daily, 3 refills.According to the instructions for use (ifu) for the gore® excluder® iliac branch endoprostheses; adverse events that may occur include, but are not limited to: endoprosthesis: occlusion of device or native vessel.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
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G9: please note that this event was reported in medwatch #3007284313-2019-00173.Details of the event required a separate medwatch submission for the trunk ipsilateral leg component; as such this medwatch is being submitted.H6: code 22: according to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoprosthesis: component migration, occlusion of device or native vessel.Additional images from the index procedure were obtained and evaluated by gore and show the following: as some of the images received were not dicom format, a full imaging evaluation could not be completed.Gore cannot make any conclusions or guarantees that non-dicom images are complete, accurate and lack alteration.Thus, findings noted are within the best ability of the reviewers but the extent of accuracy of the findings may be limited due to the completeness, format and/or quality of the images provided.Gore cannot guarantee that it has been able to capture all key findings or that the findings are accurate.¿ images received via (email) with no patient identifier or date of acquisition in image.¿ (b)(6) 2019: there appears to be a lack of wall apposition at the proximal end of the implanted device on the final procedural angiogram.¿ (b)(6) 2019: there appears to be a lack of wall apposition at the proximal end of the implanted device.¿ (b)(6) 2019: image shows what appears to be compression of the proximal end of the trunk with occlusion throughout the devices.
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