MULTI-LINK 8

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER THE LESION WAS PREDILATED USING A 2.5X15MM AND 3.5X15MM NON-ABBOTT BALLOONS, A 3.5X38MM MULTI- LINK BALLOON EXPANDABLE STENT (BES) WAS OPENED FROM ITS PACKAGE AND ADVANCED INTO THE ANATOMY; HOWEVER, THE STENT WAS NOTED TO BE DISLODGED AND WAS LOCATED INSIDE THE PROTECTIVE SHEATH. THEREFORE, ANOTHER SAME SIZED MULTI- LINK BES WAS ADVANCED INTO THE LESION AND ATTEMPTED TO BE DEPLOYED; BUT DURING DEPLOYMENT THE BALLOON WAS NOTED TO ONLY PARTIALLY INFLATE SUBSEQUENTLY RESULTING IN THE STENT NOT BEING ABLE TO BE DEPLOYED. THE STENT WAS REMOVED ALONG WITH THE DELIVERY SYSTEM OF THE MULTI- LINK BES AND THE PROCEDURE WAS COMPLETED USING A 3.5X28MM AND 4.0X28MM NON- ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER THE LESION WAS PREDILATED USING A 2.5X15MM AND 3.5X15MM NON-ABBOTT BALLOONS, A 3.5X38MM MULTI- LINK BALLOON EXPANDABLE STENT (BES) WAS OPENED FROM ITS PACKAGE AND ADVANCED INTO THE ANATOMY; HOWEVER, THE STENT WAS NOTED TO BE DISLODGED AND WAS LOCATED INSIDE THE PROTECTIVE SHEATH. THEREFORE, ANOTHER SAME SIZED MULTI-LINK BES WAS ADVANCED INTO THE LESION AND ATTEMPTED TO BE DEPLOYED; BUT DURING DEPLOYMENT THE BALLOON WAS NOTED TO ONLY PARTIALLY INFLATE SUBSEQUENTLY RESULTING IN THE STENT NOT BEING ABLE TO BE DEPLOYED. THE STENT WAS REMOVED ALONG WITH THE DELIVERY SYSTEM OF THE MULTI- LINK BES AND THE PROCEDURE WAS COMPLETED USING A 3.5X28MM AND 4.0X28MM NON- ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY REPORTED INFORMATION, BOTH DEVICES WERE RECEIVED. THE RETURNED DEVICE ANALYSIS FOR THE SECOND MULTI-LINK DEVICE USED REVEALED ONLY THE STENT WAS RETURNED. THE STENT WAS DISLODGED COMPLETELY OFF THE DELIVERY CATHETER. THE DELIVERY CATHETER WAS NOT RETURNED. STENT DAMAGE WAS NOTED AT RING 24 FROM DISTAL STENT END AND CONTINUING TO PROXIMAL STENT END. STENT DAMAGE WAS IN THE FORM OF STRETCHED, BENT, AND OVERLAPPING STRUTS. THE DAMAGES TO THE STENT WERE CONFIRMED BY THE ACCOUNT AND IT WAS NOTED THAT THE DISLODGED STENT OCCURRED POST-PROCEDURE AFTER THE DEVICE WAS ALREADY REMOVED FROM THE ANATOMY AS A SINGLE UNIT NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. BASED ON THE CONDITION OF THE RETURNED STENT THE REPORTED ACTIVATION FAILURE AND MATERIAL DEFORMATION WERE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED DEVICE ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED ACTIVATION FAILURE COULD NOT BE DETERMINED. THE REPORTED MATERIAL DEFORMATION 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. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED