MULTI-LINK VISION

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. THE REPORTED PATIENT EFFECT(S) OF STENOSIS ARE LISTED IN THE VISION CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (EL2056021 REVISION B SECTION 6.2) AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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. LITERATURE ATTACHMENT: ARTICLE TITLED: NOVEL SCAFFOLDS FOR THE TREATMENT OF BELOW-THE-KNEE PERIPHERAL ARTERIAL DISEASE WITH CHRONIC LIMB-THREATENING ISCHAEMIA: A REVIEW B3-ESTIMATED DATE D4: THE UDI NUMBER IS ¿NI¿ AS THE PART/LOT NUMBER WAS NOT PROVIDED. D6: ESTIMATED DATE. THE ADDITIONAL DEVICES REPORTED IN B5 ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT.

Description of Event or Problem

IT WAS REPORTED THROUGH AN ARTICLE THAT IN THE DESTINY TRIAL, THE MULTI-LINK VISION BARE METAL STENT (BMS) AND XIENCE V DRUG-ELUTING STENT (DES) AT THE 1-YEAR FOLLOW-UP, THE PRIMARY PATENCY IN THE EES GROUP WAS 85.4% COMPARED WITH ONLY 54.4% IN THE BMS GROUP. PATENCY WAS SUPERIOR IN THE EES GROUP FOR PATIENTS WHO HAD BOTH PROXIMAL AND DISTAL LESIONS. AT THE 1-YEAR FOLLOW-UP, 91.3% OF PATIENTS IN THE EES GROUP WERE FREE FROM TARGET LESION REVASCULARIZATION, COMPARED WITH 66.4% IN THE BMS GROUP. THERE WAS NO DIFFERENCE IN SURVIVAL BETWEEN THE TWO GROUPS AT 1 YEAR. ADDITIONALLY, 12-MONTH RESULTS OF THEIR PROSPECTIVE, SINGLE-CENTRE EXPERIENCE USING THE ABSORB BVS IN BTK PAD. SECONDARY ENDPOINTS INCLUDED CD-TLR, AMPUTATION, BYPASS SURGERY, CARDIOVASCULAR AND ALL-CAUSE MORTALITY AND ¿ANY RELATED MORBIDITY WITHIN 30 DAYS OF THE INDEX PROCEDURE'. ONE PATIENT UNDERWENT CD-TLR ON DAY 2 AFTER THE PROCEDURE AND WAS FOUND TO HAVE OCCLUSIONS IN TWO OF THE THREE BVSS PLACED. THREE PATIENTS DEVELOPED FEMORAL PSEUDOANEURYSMS DURING FOLLOW-UP; TWO OF THESE PATIENTS REQUIRED COVERED STENT PLACEMENT AND ONE REQUIRED OPEN SURGICAL REPAIR. TWELVE-MONTH SURVIVAL WAS 84.8%. FREEDOM FROM CD-TLR WAS 96% AT 6, 12 AND 24 MONTHS. PRIMARY PATENCY WAS 96%, 96% AND 84.6% AT 6, 12 AND 24 MONTHS RESPECTIVELY. A POOLED ANALYSIS OF THREE SEPARATE REAL-WORLD COHORTS USING THE ABSORB BVS IN BTK PAD. THE PRIMARY ENDPOINT IN THIS ANALYSIS WAS FREEDOM FROM RESTENOSIS, WITH SECONDARY ENDPOINTS OF FREEDOM FROM CD-TLR, MAJOR AMPUTATION AND SURVIVAL. THE PRIMARY ENDPOINT OF FREEDOM FROM RESTENOSIS WAS ACHIEVED IN 91.7% AND 86.6% OF PATIENTS AT 12 AND 24 MONTHS, RESPECTIVELY. FREEDOM FROM CD-TLR WAS 97.2% AND 96.6% AT 12 AND 24 MONTHS, RESPECTIVELY, WITH MAJOR AMPUTATION IN ONLY 1.6% OF LIMBS AT 24 MONTHS. OVERALL SURVIVAL WAS 85% AT 24 MONTHS. DETAILS ARE LISTED IN THE ARTICLE TITLED, "NOVEL SCAFFOLDS FOR THE TREATMENT OF BELOW-THE-KNEE PERIPHERAL ARTERIAL DISEASE WITH CHRONIC LIMB-THREATENING ISCHAEMIA: A REVIEW".