Description of Event or Problem · 1
HEARTMATE 2 LVAD PT BROUGHT IN FOR ROUTINE HEART TRANSPLANT ON (B)(6) 2016. LAB RESULTS PRIOR TO TRANSPLANT REVEALED ELEVATED LACTATE DEHYDROGENASE (LDH) LEVEL, WHICH IS A MARKER OF HEMOLYSIS IN LVAD PTS. LVAD APPEARED TO BE OPERATING OTHERWISE NORMALLY. PT EXPERIENCED A HEMORRHAGIC STROKE SHORTLY AFTER TRANSPLANT, WHICH MAY HAVE BEEN SEQUELAE OF THE PUMP THROMBOSIS. DEVICE WAS QUARANTINE AT TIME OF TRANSPLANT IN PATHOLOGY PER STANDARD PROCEDURE AND RETURNED TO ST. JUDE MEDICAL ON 08/19/2016 FOR ANALYSIS AND INVESTIGATION. COMPLAINT #(B)(4), CS-082430 (HEARTMATE II LVAD, SN #(B)(4), PT ID (B)(6); DATE OF IMPLANT: (B)(6) 2016; EVENT DATE: (B)(6) 2016). THROMBUS WAS CONFIRMED BASED ON THE EVAL OF THE RETURNED LVAD, SN #(B)(4). THE PUMP WAS RETURNED WITH THE DRIVELINE CUT APPROX 16.5" FROM THE PUMP HOUSING AND THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE PROXIMAL-SIDE OF THE OUTLET STATOR REVEALED A NON-LAMINATED DEPOSITION SITUATED AROUND THE OUTLET BEARING BALL AND IN BETWEEN THE STATOR BLADES WHICH APPEARED TO OCCLUDE THE BLOOD PATHWAY. THE LACK OF LAMINATED LAYERING SUGGESTS THAT THE DEPOSITION DID NOT FORM IN THE OUTLET STATOR. ALTHOUGH ITS ORIGIN AND DURATION OF TIME FOR WHICH THE DEPOSITION WAS PRESENT WITHIN THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED, AREAS OF THE DEPOSITION HAD EVIDENCE OF DENATURATION, AND THE CIRCUMFERENTIAL CONTACT MARKS ON THE OUTLET BEARING CUP AND OUTLET CONE SECTION, INDICATE THAT THE DEPOSITION WAS LIKELY PRESENT IN THE OUTLET STATOR WHILE THE PUMP WAS SUPPORTING THE PT. THE DEPOSITION FOUND IN THE EVAL OF THE RETURNED PUP COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED ELEVATED LACTATE DEHYDROGENASE (LDH) LEVEL; HOWEVER, A CORRELATION BETWEEN THE OBSERVED DEPOSITION AND THE PT'S HEMORRHAGE STROKE COULD NOT BE CONCLUSIVELY DETERMINED.