MULTI-LINK 8

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF THROMBOSIS/THROMBUS, MYOCARDIAL INFARCTION AND DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. ARTICLE TITLED "INVASIVE FUNGAL INFECTION IN A NEONATE WITH TETRALOGY OF FALLOT AFTER REPEATED RIGHT VENTRICLE OUTFLOW TRACT STENTING: DIAGNOSIS, TREATMENT, MONITORING, AND THERAPEUTIC SUCCESS". B3: ESTIMATED DATE. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6: ESTIMATED DATE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS A 5-MONTH-OLD MALE WITH TETRALOGY OF FALLOT (TOF) AFTER REPEATED PERCUTANEOUS RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) STENTING. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PROFOUND CYANOSIS SUGGESTING DECREASED PULMONARY BLOOD FLOW. ECHOCARDIOGRAPHY DEMONSTRATED SIGNIFICANT NARROWING AT THE SITE OF A PREVIOUSLY IMPLANTED STENT, ACCOMPANIED BY SEVERE STENOSIS OF THE LEFT BLALOCK-TAUSSIG SHUNT (LBTS) AND MILD RESIDUAL COARCTATION OF THE AORTA. THE PATIENT UNDERWENT CARDIAC CATHETERIZATION TO RELIEVE THE OBSTRUCTIONS. THE SUCCESSFUL BALLOON ANGIOPLASTY OF THE LBTS WAS PERFORMED AND THE COARCTATION WAS DILATED. DUE TO NARROWING AND FRACTURES WITHIN THE PREVIOUSLY IMPLANTED RVOT STENT, A 4 × 18 MM MULTI-LINK STENT IMPLANTED VIA THE LBTS TO ADDRESS THE OBSTRUCTION AND REINFORCE THE FRACTURED STENT. THE CARDIAC CATHETERIZATION PROCEDURE WAS UNCOMPLICATED. HOWEVER, DURING THE FIRST 24 H IN THE INTENSIVE CARE UNIT, THE PATIENT EXPERIENCED EPISODES OF BRADYCARDIA AND HYPOXEMIA, REQUIRING BRIEF RESUSCITATION, REINTUBATION AND INOTROPIC SUPPORT. LABORATORY INVESTIGATIONS REVEALED INDICATIONS OF SEPSIS. BLOOD CULTURES CONFIRMED THE GROWTH OF CANDIDA GLABRATA; THEREFORE, THE PATIENT WAS TREATED WITH MEDICATION FOR 6 WEEKS AND DURING THIS TIME THE PATIENT'S CONDITION GRADUALLY STABILIZED. ADDITIONAL INFORMATION CAN BE FOUND IN THE CASE STUDY ARTICLE, "INVASIVE FUNGAL INFECTION IN A NEONATE WITH TETRALOGY OF FALLOT AFTER REPEATED RIGHT VENTRICLE OUTFLOW TRACT STENTING: DIAGNOSIS, TREATMENT, MONITORING, AND THERAPEUTIC SUCCESS".