MULTI-LINK 8

Additional Manufacturer Narrative

A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED STENT DISLODGEMENT WAS 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 STENT DISLODGEMENT COULD NOT BE DETERMINED. STENT DISLODGEMENT MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, INTERACTION WITH THE ANATOMY, OR INTERACTION WITH ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THAT INADVERTENT MISHANDLING DURING SHEATH/STYLET REMOVAL MAY HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

Description of Event or Problem

IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 3X38MM RX MULTI-LINK 8 BALLOON EXPANDABLE STENT (BES), THAT THE STENT WAS NOTED TO BECOME DISLODGED AFTER THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE NOTED DURING THE REMOVAL FROM THE DISPENSER COIL NOR PROTECTIVE SHEATH. THEREFORE, A 3X38MM MULTI-LINK BES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY REPORTED. 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.