ACS RX MULTI-LINK¿ CORONARY STENT SYSTEM

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. ATTACHMENT ARTICLE TITLED "FETOSCOPIC BALLOON DILATION AND STENT PLACEMENT OF CONGENITAL HIGH AIRWAY OBSTRUCTION SYNDROME LEADING TO SUCCESSFUL CESAREAN DELIVERY". B3, B6: ESTIMATED DATE. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A, D6B: ESTIMATED DATES.

Description of Event or Problem

IT WAS REPORTED THAT AT 31 WEEKS GESTATION THE FETAL PATIENT PRESENTED IN UTERO WITH ANOMALIES, INCLUDING ECHOGENIC LUNGS, TRACHEOBRONCHIAL DILATION, AND FLATTENED DIAPHRAGMS. AT 32 WEEKS, FETOSCOPIC EVALUATION IDENTIFIED LARYNGEAL STENOSIS, WHICH WAS SUBSEQUENTLY TREATED WITH BALLOON DILATION AND IMPLANTATION OF THE 4X12MM BARE METAL MULTILINK VISION STENT. AT POSTOPERATIVE DAY 7, THE PATIENT DEVELOPED SONOGRAPHIC SIGNS OF CONGENITAL HIGH AIRWAY OBSTRUCTION SYNDROME (CHAOS), WHICH PROMPTED A REPEAT FETOSCOPY; HOWEVER, THE STENT LUMEN WAS NOTED TO BE OBSTRUCTED BY FIBRINOUS EXUDATE. AS A RESULT, A NON-ABBOTT BALLOON WAS USED TO CLEAR THE OBSTRUCTION. AFTER THE STENT WAS CONFIRMED TO BE PATENT, THE FETUS WAS DELIVERED BY CESAREAN. IMMEDIATELY AFTER BIRTH, AN ATTEMPT WAS MADE TO INTUBATE THROUGH THE MULTILINK STENT; HOWEVER, WAS UNSUCCESSFUL AND THE DISTAL END OF THE STENT WAS NOTED TO BE DISPLACED. THEREFORE, THE STENT WAS REMOVED. A TRACHEOSTOMY WAS THEN IMMEDIATELY PERFORMED FOR ANTICIPATED LONG-TERM AIRWAY AND PULMONARY MANAGEMENT. THE PROCEDURES WERE WELL TOLERATED. THE BABY DEMONSTRATED SPONTANEOUS HEALING OF THE TRACHEOESOPHAGEAL FISTULA BY DAY OF LIFE 7 WITH DISCHARGE HOME WITH VENTILATOR SUPPORT AT 3 MONTHS OF LIFE. ADDITIONAL INFORMATION CAN BE FOUND IN THE CASE STUDY ARTICLE, "FETOSCOPIC BALLOON DILATION AND STENT PLACEMENT OF CONGENITAL HIGH AIRWAY OBSTRUCTION SYNDROME LEADING TO SUCCESSFUL CESAREAN DELIVERY".

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. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED STENT DEFORMATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE MULTI-LINK 8, MULTI-LINK 8 SV UND MULTI-LINK 8 LL CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.