MULTI-LINK 8

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE 4X29MM MULTI-LINK 8 BALLOON EXPANDING STENT (BES), THE STENT BECAME DISLODGED FROM THE BALLOON. THE STENT REMAINED IN THE PROTECTIVE SHEATH AND THE BES WAS NOT USED IN THE PATIENT. A NON-ABBOTT 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.

Additional Manufacturer Narrative

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

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 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 OR DURING PREPARATION OF THE DEVICE 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. H6: HEALTH EFFECT - IMPACT CODE 4656 REMOVED.

Description of Event or Problem

SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4X29MM MULTI-LINK 8 BALLOON EXPANDING STENT (BES) WAS ADVANCED IN THE PATIENT; HOWEVER, THE STENT WAS NOTED TO NOT BE ON THE DELIVERY SYSTEM BALLOON AND FOUND TO BE IN THE PROTECTIVE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.