The device was not returned for investigation.No return product evaluation could be completed.The device lot history record review indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.Based on the information submitted, following a tavr procedure, a manta 18f was prepared to deploy for access in the left common femoral artery.Patient arteriotomy was 8.8 x 9mm with moderate anterior and posterior calcification at the femoral head and an extreme amount of calcification below the femoral head.Manta deployment depth was measured at 3.5 + 1.A pre-deployment angiogram revealed a hip prosthesis blocking the view of the access site making it difficult to identify where the surgeon made initial access.The surgeon decided to do a blind stick into the groin without the use of ultrasound.Activated clotting time (act) was noted at 289.During deployment, the manta anchor did not deploy, and the complete manta closure device pulled out of the access site.A second device was then inserted, however, unsuccessful in closing the access.Copious bleeding was present, a cut down was performed, an endarterectomy of the calcium, and patched the vessel.Following the procedure, the surgeon mentioned this was not a manta failure, it was too heavily calcified."there was a huge rock of calcium there"; and had accessed directly into calcium rock.Additionally, post-procedure the surgeon noted access was in the left femoral artery 1cm above the bifurcation.The ifu was reviewed and confirmed to list warning: do not use in patients with severe calcification of the access vessel and/or common femoral artery stenosis resulting in a vessel <5mm in diameter for the 14f manta or <6mm in diameter for the 18f manta, or >50% diameter femoral or iliac artery stenosis.Do not use if the puncture site is at or distal to the bifurcation of the superficial femoral and profunda femoris artery, as this may result in the 1) anchor catching on the bifurcation or being positioned incorrectly, and/or 2) collagen deposition into the vessel.If the manta closure does not deploy properly in the artery and hemostasis is not achieved, the closure and all absorbable components may be removed from the patient if medically necessary.Arterial access should be gained using micro-puncture technique using ultrasound guidance to puncture the midline of the femoral artery.Do not puncture the posterior wall of the artery.Activated clotting time (act) should be below 250 seconds prior to closure.Confirm via femoral arteriogram: no evidence of significant peripheral vascular disease or calcification in the region of the arteriotomy.
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