Information obtained from medrio study database: file name: l-change-reint_20220201.Recvd: 2/4/2022.Side branch (vbx) bxa055902a/ 20315585 used in right renal artery (most proximal within the portal) side branch (vbx) bxa071902a/21271667 used in right renal artery (first distal extension) side branch (vbx) bxa 053902a/24277912 used in right renal artery (most proximal within the portal) procedure date: (b)(6) 2019 dr (b)(6).The university of (b)(6).White male, dob (b)(6) 1935, weight (b)(6).Comorbidities: coronary artery bypass graft, percutaneous coronary intervention, coronary artery disease, hypercholesterolemia, hypertension, atrial fibrillation, and colorectal cancer.Medications: aspirin, warfarin, study pt: (b)(6).Adverse event - 03 date of onset - possible right renal artery stent crushed/slightly narrowed ritype: procedure done on (b)(6) 2022, had stent placed (vbx 5 x 39 and an icast 6 x 38).
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It is unclear as to the identification of which device/devices failed within the procedure, so all 3 will be included in the narrative and manufacturing records were pulled for all 3 devices used.A review of the manufacturing records for lot # 20315585 indicated the device met pre-release specifications.A review of the manufacturing records for lot # 21271667 indicated the device met pre-release specifications.A review of the manufacturing records for lot # 24277912 indicated the lot met pre-release manufacturing specifications.Due to no device return, an investigation could not be performed.
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