GRAFTMASTER

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3, B6: DATES ESTIMATED.

Description of Event or Problem

A 2.8X19MM GRAFTMASTER COVERED STENT DELIVERY SYSTEM (SDS) WAS RETURNED. RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS DISLODGED AND THE GUIDEWIRE PORT WAS TORN. UPON CONTACTING THE ACCOUNT, THE DETAILS OF THE CASE ARE UNKNOWN, HOWEVER, THEY ASSUME THE DAMAGE OCCURRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE ACCOUNT WAS UNABLE TO PROVIDE THE EVENT DETAILS OF THE CASE AS THEY ARE UNKNOWN. 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 DEVICE WAS RETURNED BY THE HOSPITAL FOR A PREVIOUS COMPLAINT; HOWEVER, IT WAS DETERMINED BY THE HOSPITAL THAT THE INCORRECT PRODUCT WAS RETURNED. THEREFORE, THIS EVENT WAS CREATED TO CAPTURE THE INCORRECT PRODUCT RETURN. THE ACCOUNT WAS UNABLE TO PROVIDE THE EVENT DETAILS OF THE CASE AS THEY ARE UNKNOWN, HOWEVER, THE ACCOUNT REPORTED THAT THEY ASSUME THE DAMAGE OCCURRED DURING THE PROCEDURE. BASED ON THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE OBSERVED ISSUES COULD NOT BE DETERMINED. 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.