Description of Event or Problem · 0
THIS PATIENT WAS A 35-YEAR-OLD FEMALE WITH PAST MEDICAL HISTORY OF DIABETES MELLITUS, ASTHMA, ADVANCED HEART FAILURE WITH EJECTION FRACTION OF 15-20%, STEMI STATUS-POST DRUG-ELUTING STENTS (DES) TO MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). ON (B)(6) 2022, THE PATIENT PRESENTED TO (B)(6) MEDICAL CENTER WITH SUBACUTE WORSENING DYSPNEA ON EXERTION, CONCERNING FOR PNEUMONIA LEADING TO ACUTE ON CHRONIC HEART FAILURE WITH A REDUCED EJECTION FRACTION (HFREF). ON (B)(6) 2022, A TELEFLEX ULTRA FLEX 7F 40CC INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. ON (B)(6) 2022, THE PATIENT DEVELOPED ACUTE LIMB ISCHEMIA OF BOTH FEET DUE TO THROMBOEMBOLI THOUGHT TO BE COMING FROM THE IABP. THE PATIENT WAS NOTED TO BE APPROPRIATELY ANTICOAGULATED AT THE TIME. THE IABP WAS REMOVED, THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PATIENT WAS FURTHER ANTICOAGULATED AND DEVELOPED EPISODES OF GASTROINTESTINAL AND VAGINAL BLEEDING, MAKING HER NOT A SURGICAL CANDIDATE FOR A BIVENTRICULAR ASSIST DEVICE SURGERY. AFTER DISCUSSIONS WITH THE PATIENT'S FAMILY, SHE WAS TRANSITIONED TO COMFORT MEASURES ONLY. ON (B)(6) 2022, THE PATIENT EXPIRED. IN DECEMBER 2022, ANOTHER INPATIENT AT (B)(6) MEDICAL CENTER HAD THE TELEFLEX ULTRA FLEX 7F 40 CC INTRA-AORTIC BALLOON PUMP (IABP) PLACED FOR SUPPORT AND THE SAME DAY DEVELOPED THOMBI IN THE RIGHT HEPATIC ARTERY THOUGHT TO BE RELATED TO IABP. HIS IABP WAS REMOVED ON (B)(6) 2022. THAT PATIENT DEVELOPED A WORSENING ACUTE KIDNEY INJURY ON CHRONIC KIDNEY DISEASE, AND THERE IS A CONCERN FOR POSSIBLE GUT ISCHEMIA AND LIMB ISCHEMIA, BUT HE IS CURRENTLY STILL ADMITTED AND STABLE IN THE HOSPITAL. THIS EVENT WAS REPORTED TO THE MANUFACTURER OF THE IABP, TELEFLEX. UPON REVIEW OF THIS EVENT, WE CONSIDERED PATIENT RE AND WHETHER HER OUTCOME WAS RELATED TO THE IABP ITSELF. WE BELIEVE THERE IS A POTENTIAL THAT THE IABP CAUSED OR CONTRIBUTED TO PATIENT RE'S DEATH, AS WELL AS OUR CURRENT PATIENT'S SERIOUS INJURY. BOTH PATIENTS WERE DETERMINED TO HAVE BEEN APPROPRIATELY ANTICOAGULATED, BUT THE PATIENTS DEVELOPED CLOTS WHEN IT WOULD NOT BE GENERALLY EXPECTED TO SEE A CLOT. THERE IS A POTENTIAL THAT THERE IS SOME ASPECT OF THE IABP ITSELF WHICH IS LEADING TO CLOT FORMATION. WE HAVE CONSIDERED THE POSSIBILITY THAT ISSUES WITH THE STASIS OF FLOW OF THE BALLOON, THE SIZE OR LENGTH OF THE BALLOON, OR THROMBOGENICITY OF THE PLASTIC USED COULD BE LEADING TO INCREASED CLOT FORMATION, BUT THESE ARE THEORIES AND WOULD REQUIRE FURTHER ANALYSIS AND TESTING TO DETERMINE IF ANY OF THESE MAY BE A CAUSE, OR IF THERE IS SOME OTHER CAUSE.