GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, WHICH OCCURRED POST ANGIOPLASTY AND CORONARY LITHOTRIPSY. THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATM) HOWEVER THE PERFORATION WAS NOT SEALED. THE 3.5X26 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATM HOWEVER THERE WAS STILL EXTRAVASATION AND THE PATIENT DECOMPENSATED, WENT INTO SHOCK AND ULTIMATELY EXPIRED. 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. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

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 PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. ADDITIONALLY, THE PATIENT WAS DECLINING IN HEALTH TOWARDS DEATH PRIOR TO USE OF THE GRAFTMASTER STENTS. THE PHYSICIAN STATED THAT THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. 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. B2: CORRECTION: OUTCOMES ATTRIBUTED TO AE CORRECTED FROM DEATH TO SERIOUS INJURY. H1: CORRECTION: TYPE OF REPORTABLE EVENT CORRECTED FROM DEATH TO SERIOUS INJURY. H6: CORRECTION: HEALTH EFFECT CLINICAL CODE 2072 WAS REMOVED AND CODE 4582 WAS ADDED. H6: CORRECTION: HEALTH EFFECT IMPACT CODE 1802 WAS REMOVED AND CODES 2199, 4657 WERE ADDED.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS REPORTED THAT BOTH OF THE GRAFTMASTER DEVICES HAD DIFFICULTY BEING PLACED IN THE CORRECT POSITION DUE TO VISIBILITY ISSUES. THE STENTS WERE NOT IMPLANTED OVER THE HOLE; THEREFORE THE PERFORATION CONTINUED TO LEAK. THE PATIENT WAS DECLINING IN HEALTH TOWARDS DEATH PRIOR TO USE OF THE GRAFTMASTER STENTS. THE GRAFTMASTER STENTS DID NOT CAUSE ANY ADVERSE PATIENT EFFECTS. THE PHYSICIAN STATED THAT THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.