(b)(4).Additional device: (b)(4).It is not known which device appeared to have become compressed, therefore both devices were investigated.A review of the manufacturing records for the devices verified the lots met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), in the pre-treatment planning it states: determine accurate size of anatomy and proper size of trunk-ipsilateral and contralateral endoprostheses (tables 21 and 22) and aortic and iliac extender endoprostheses (tables 23 and 24).Per the trunk-ipsilateral leg endoprosthesis sizing guide, the intended iliac vessel diameter for the rlt23416 device is 12-13.5 mm.Per the contralateral leg endoprosthesis sizing guide the intended iliac vessel diameter for the plc271000 21.5-25 mm.
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