ACS RX MULTI-LINK¿ CORONARY STENT SYSTEM

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 ISSUE APPEARS TO BE RELATED TO USER ERROR AS THE DEVICE WAS USED OUTSIDE OF THE INDICATIONS LISTED IN THE MULTI-LINK INSTRUCTIONS FOR USE. THE REPORTED TREATMENT APPEARS TO BE RELATED TO 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. ATTACHMENT LITERATURE ARTICLE TITLED "INSTITUTIONAL EXPERIENCE WITH DUCTUS ARTERIOSUS STENTING IN NEONATES WITH DUCT DEPENDENT PULMONARY CIRCULATION: PROCEDURAL OUTCOMES & MID-TERM FOLLOW UP". B3, D6A - DATE OF PROCEDURE/IMPLANT ESTIMATED AS (B)(6) 2018. H6 MEDICAL DEVICE PROBLEM CODE: 1494 - PATIENT SELECTION.

Description of Event or Problem

THE ARTICLE EVALUATES THE PROCEDURAL AND MID-TERM OUTCOMES OF NEONATAL DUCTAL STENTING (DS) FOR CRITICAL INTERVENTION FOR NEONATES WITH DUCT-DEPENDENT PULMONARY CIRCULATION (DDPC) AT A HIGH VOLUME TERTIARY CARDIAC CENTRE BETWEEN JANUARY 2018 AND AUGUST 2023. THE DUCT WAS USUALLY NEGOTIATED WITH A 0.014 FLOPPY-TIPPED WORKHORSE GUIDE WIRE (GW) (BALANCE MIDDLE WEIGHT, WHISPER MS OR CHOICE PT EXTRA SUPPORT) WERE USED TO NEGOTIATE TORTUOUS PDA (SINGLE WIRE TECHNIQUE) OR SUPPORT TRACKING OF THE STENT WITH OR WITHOUT WORKHORSE GW (DUAL WIRE TECHNIQUE) WITH THE DISTAL TIPS OF GW PARKED IN DISTAL BRANCHES OF EITHER ONE OR BOTH PULMONARY ARTERIES. STENTS INCLUDED BARE-METAL STENTS (BMS) MULTI-LINK OR DRUG-ELUTING STENTS (DES) BOSTON SCIENTIFIC PROMUS PREMIER OR ABBOTT XIENCE. THE PRE-MOUNTED CORONARY STENTS WERE DEPLOYED IN ALL THE CASES AFTER CONFIRMATION OF COVERAGE OF BOTH ENDS OF DUCT IN APPROPRIATE ANGIOGRAPHIC PROJECTIONS. PROCEDURAL COMPLICATIONS INCLUDED DIFFICULTY ADVANCING. ADVERSE EVENTS INCLUDED ACUTE LIMB ISCHEMIA, PULMONARY EDEMA, PULMONARY HEMORRHAGE, BRADYCARDIA, HYPOTENSION, DISSECTION WITH SUBSEQUENT SEVERE CYANOSIS, SEPSIS, STENT THROMBOSIS, CONTRAST INDUCED NEPHROPATHY, LEFT VENTRICLE DYSFUNCTION, AORTO-PULMONARY SHUNT, RE-INTERVENTIONS, DISTORTED PULMONARY ARTERY, AND DEATH. RE-INTERVENTIONS WERE REQUIRED IN 11 % IN THOSE WITH DES AND 14.2 % IN THOSE WITH BMS. THE ARTICLE CONCLUDED THAT DS IS A FEASIBLE AND EFFECTIVE STRATEGY IN A VARIETY OF DIFFERENT CASES OF DDPC. FURTHER RESEARCH IS NEEDED TO EXPLORE LONG-TERM OUTCOMES AND OPTIMAL STENT SELECTION BASED ON INDIVIDUAL PATIENT CHARACTERISTICS. DETAILS ARE LISTED IN THE ARTICLE TITLED, ¿INSTITUTIONAL EXPERIENCE WITH DUCTUS ARTERIOSUS STENTING IN NEONATES WITH DUCT DEPENDENT PULMONARY CIRCULATION: PROCEDURAL OUTCOMES & MID-TERM FOLLOW UP". NO ADDITIONAL INFORMATION WAS PROVIDED. DATE OF PROCEDURE ESTIMATED AS (B)(6) 2018.