GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED BY THE RETURN DEVICE ANALYSIS THAT A 2.8X26MM GRAFTMASTER COVERED STENT WAS RETURNED WITH TWO SEPARATIONS. THE FIRST SEPARATION WAS OF THE INNER MEMBER LOCATED 25CM FROM THE DISTAL TIP. THE SECOND SEPARATION WAS OF THE OUTER MEMBER LOCATED 22.5CM FROM THE DISTAL TIP. THERE WERE MULTIPLE BENDS ON THE JACKETED HYPOTUBE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. 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. IN THIS CASE, THE ACCOUNT DID NOT PROVIDE ANY INFORMATION REGARDING THE RETURNED DEVICE. A CONCLUSIVE CAUSE FOR THE OBSERVED DAMAGES (MATERIAL SEPARATION TO SHAFT AND KINKED HYPOTUBE) COULD NOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT INTERACTION AGAINST RESISTANCE CONTRIBUTED TO THE OBSERVED SHAFT SEPARATION. 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. B3: ESTIMATED DATE.