GRAFTMASTER

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A HEAVILY CALCIFIED, HEAVILY TORTUOUS, LEFT CIRCUMFLEX CORONARY ARTERY. THE 2.80 X 19 MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. A NEW GRAFTMASTER COVERED STENT WAS USED TO SEAL THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, DEVICE ANALYSIS OBSERVED THE STENT IMPLANT STATIONARY ON THE BALLOON BUT NOT BETWEEN THE MARKERS AND THE PURPLE DISTAL SOFT TIP WAS SEPARATED FROM THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE SDS WAS RETURNED WITH THE STENT IMPLANT STATIONARY ON THE BALLOON, BUT NOT BETWEEN THE MARKERS AND THE PURPLE DISTAL SOFT TIP WAS SEPARATED FROM THE BALLOON. ADDITIONAL FOLLOW UP WITH THE ACCOUNT STATED THEY WERE UNAWARE OF THE OBSERVED STENT DISLODGEMENT AND SEPARATED TIP WHICH LIKELY OCCURRED DURING HANDLING/PACKAGING OF THE DEVICE FOR RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE REPORTED FAILURE TO ADVANCE COULD NOT BE EVALUATED AS THE EXACT ANATOMICAL CONDITIONS ENCOUNTERED BY THE DEVICE USED DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST LABORATORY. 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 FAILURE TO ADVANCE COULD NOT BE DETERMINED. FACTORS THAT COULD CONTRIBUTE TO FAILURE TO ADVANCE INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, INTERACTION WITH PREVIOUSLY PLACED STENTS OR ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION DURING ADVANCEMENT, CAUSING THE REPORTED FAILURE TO ADVANCE AND OBSERVED BUNCHED OUTER MEMBER; HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE ACCOUNT, THIS CANNOT BE CONFIRMED. 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. D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED TO YES H6 CORRECTION: MEDICAL DEVICE PROBLEM CODE 1562 AND 2923 WERE ADDED, TYPE OF INVESTIGATION CODE 4114 REMOVED AND 10 ADDED.

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 FAILURE TO ADVANCE COULD NOT BE DETERMINED. FACTORS THAT COULD CONTRIBUTE TO FAILURE TO ADVANCE INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, INTERACTION WITH PREVIOUSLY PLACED STENTS OR ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION DURING ADVANCEMENT, CAUSING THE REPORTED FAILURE TO ADVANCE; HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE ACCOUNT AND WITHOUT THE DEVICE TO EXAMINE, THIS CANNOT BE CONFIRMED. 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. D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.