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. ADDITIONALLY, A REVIEW OF THE COMPLAINT IDENTIFIED NO SIMILAR INCIDENT REPORTED FROM THIS LOT. A DEFINITIVE CAUSE FOR THE REPORTED UNINTENDED MOVEMENT AND PATIENT EFFECT OF HEMATOMA COULD NOT BE DETERMINED. THE REPORTED POOR IMAGING WAS DUE TO CHALLENGING PATIENT ANATOMY. THE PATIENT EFFECT OF HEMATOMA AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), IS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. THE TWO CLIP DELIVERY SYSTEM DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.
D
Patient 1
THIS IS FILED TO REPORT DURING THE PROCEDURE, THE SGC SLIPPED BACK INTO THE RIGHT ATRIUM. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4. IMAGING WAS DIFFICULT AS THE PATIENT'S HEART WAS SITTING ON THE RIGHT SIDE OF THE CHEST AND WAS ROTATED. THE TRANSSEPTAL PUNCTURE WAS HIGH AND IN THE THICK PART OF THE SEPTUM. DUE TO THE TRANSSEPTAL NEEDLE, AN INTERATRIAL HEMATOMA WAS FORMING. THERE WAS NO TREATMENT FOR THE HEMATOMA REQUIRED. HOWEVER, THE HEMATOMA COULD HAVE BEEN CAUSED EITHER BY THE TRANSSEPTAL PUNCTURE OR THE STEERABLE GUIDE CATHETER (SGC) (90522U106) DURING INSERTION INTO THE SEPTUM. THE SGC WAS POSITIONED AND THE FIRST CLIP DELIVERY SYSTEM (CDS) (90412U373) WAS ADVANCED AND POSITIONED ON THE LEAFLET. CLIP DEPLOYMENT WAS INITIATED, BUT THE CLIP DID NOT DETACH FROM THE DELIVERY SYSTEM. AFTER SOME TROUBLE SHOOTING, THE CLIP DETACHED, AND MR WAS IMPROVED, BUT REMAINED AT 4. DURING CLIP DEPLOYMENT, THE SGC WAS PULLED INTO THE RIGHT ATRIUM AND COULD NOT BE MOVED BACK INTO THE LEFT ATRIUM, SO THE SGC WAS REMOVED. A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED AND A SECOND SGC AND CDS (90412U374) WERE INSERTED. THE CLIP WAS SUCCESSFULLY POSITIONED AND DEPLOYED WITHOUT ISSUES, REDUCING MR TO 2; HOWEVER, DURING CLIP POSITIONING, THE SYSTOLIC BLOOD PRESSURE WAS MORE DIFFICULT TO MAINTAIN, THE HEART RATE INCREASED, AND EKG CHANGES WERE NOTED. MEDICATION WAS ADMINISTERED. AFTER REMOVAL OF THE CDS, THE BP WAS 79/57 AND A PERICARDIAL EFFUSION WAS NOTED AT THE APEX OF THE RIGHT VENTRICLE. AN ANGIOGRAM WAS PERFORMED, AND THE CORONARY ARTERIES WERE NORMAL. THERE WAS NO TREATMENT DONE FOR THE PERICARDIAL EFFUSION. THE PATIENT WAS HEMODYNAMICALLY STABLE, AND THE DECISION WAS MADE TO WAIT AND OBSERVE THE PATIENT'S CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.