MULTI-LINK 8

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED STENT. 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 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 IN ADDITION TO THE OBSERVED MATERIAL DEFORMATION (BENT STENT); HOWEVER, THIS CANNOT BE CONFIRMED. 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.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE 2.5X38 MULTI-LINK 8 BALLOON EXPANDING STENT (BES), THE STENT WAS DISLODGED. THEREFORE, THE BES WAS NOT USED IN THE PROCEDURE. ANOTHER SAME SIZE MULTI-LINK 8 BES WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.