GRAFTMASTER

Description of Event or Problem

SUBSEQUENTLY, AFTER THE PREVIOUS REPORT WAS FILED IT WAS NOTED THAT A 2.8X19MM GRAFTMASTER FAILED TO CROSS DUE TO ANATOMY AFTER MULTIPLE ATTEMPTS INCLUDING POST DILATATION AND THE USE OF UNSPECIFIED GUIDELINERS. THE PERFORATION WAS EVENTUALLY SEALED WITH MULTIPLE INFLATIONS WITH THE UNSPECIFIED PRE-DILATATION BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. 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. D4 CORRECTION: MODEL, CATALOG NUMBER UPDATED D4 CORRECTION: LOT NUMBER UPDATED D4 CORRECTION: PRIMARY UDI NUMBER ADDED D9: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM NI TO NO E1: FIRST, LAST NAME UPDATED E3: OCCUPATION UPDATED FROM NI TO PHYSICIAN.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3 - DATE OF EVENT: ESTIMATED. D4 - PRIMARY UDI NUMBER: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT THE GRAFTMASTER COVERED STENT FAILED TO CROSS THE LESION. NO OTHER DEVICES WERE ABLE TO CROSS THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.