The manufacturer was notified on 05-oct-2016 of the following: the patient is a (b)(6) male who had been treated for endocarditis, having avr, mvp, cabg x3 using lima and right greater saphenous vein.Intra-op annulus was measured at 22mm and no stj measurement was taken to figure out a ratio.Three distal graft were performed before the valves.The surgeon open the left atrium and placed 28mm carbiomedics annuloflo ridge ring on the mitral then closed the left atrium.Next he opened the aorta to debride the leaflets and inspect the annulus.There were no abscesses or damage to the annulus from the endocarditis.He started sizing and felt that the large size valve was correct.Valve was prepared according to ifu with no problems while the surgeon placed the three guide sutures 2mm below the nadir.Valve was lowered and checked before deployed.Valve looked good and was balloon at 4atms for 30 seconds with warm saline.Valve was inspected again after ballooning and no issues were seen.The aortotomy was closed and two proximals were done.Crossclamp was removed and heart de-aired.First look at echo the valve had migrated into the valsalva.(i was able capture this image).The crossclamp was then reapplied and heart stopped to remove the valve.The perceval 25/l was explanted and a perceval 23/m was used.Total bypass time 212 minutes.Total cross clamp time: 180 minutes.First cross clamp time: 105 minutes.
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Design history record review completed mar 31, 2017.The complete manufacturing and material records for the perceval heart valve, model icv1210, s/n (b)(4), were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model icv1210) perceval heart valve at the time of manufacture and release.
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