THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE PATIENT EFFECTS OF HYPOTENSION AND PERICARDIAL EFFUSION, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. A DEFINITIVE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION COULD NOT BE DETERMINED; HOWEVER, THE REPORTED HYPOTENSION WAS DUE TO THE REPORTED PERICARDIAL EFFUSION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF HYPOTENSION, PERICARDIAL EFFUSION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.
D
Patient 1
THIS IS FILED TO REPORT THE PERICARDIAL EFFUSION. IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT GRADE 3 MIXED MITRAL REGURGITATION (MR). AFTER THE STEERABLE GUIDE CATHETER (SGC) WAS INSERTED A SMALL PERICARDIAL EFFUSION WAS NOTED. THE PATIENTS? BLOOD PRESSURE DROPPED; MEDICATION WAS USED FOR TREATMENT FOR THE EFFUSION AND HYPOTENSION. THE PROCEDURE WAS ABORTED. NO CLIPS WERE IMPLANTED, MR REMAINS AT A GRADE OF 3. PER THE PHYSICIAN, IT IS UNKNOWN IF THE EFFUSION WAS CAUSED BY THE GUIDE WIRE OR THE SGC. NO ADDITIONAL TREATMENT IS PLANNED FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.