JOSTENT GRAFTMASTER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED; HOWEVER, FACTORS CONTRIBUTING TO A SHAFT BREAK INCLUDE, BUT ARE NOT LIMITED TO, KINKS/BENDS, INADVERTENT MISHANDLING DURING UNPACKAGING, DURING PREPARATION OR DURING USE OF THE DEVICE, INTERACTION WITH THE ANATOMY AND/OR ACCESSORY DEVICES. FACTORS WHICH MAY CONTRIBUTE TO DIFFICULTY ADVANCING THE DEVICE IN THE GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE TO THE STENT, DAMAGE TO THE GUIDING CATHETER, GUIDING CATHETER SIZE SELECTION OR PROCEDURAL TECHNIQUE (DEVICES NOT PROPERLY SUPPORTED OR COAXIALLY ALIGNED). IN THIS CASE, IT IS POSSIBLE THAT THE REPORTED DIFFICULT TO ADVANCE THROUGH THE GUIDE CATHETER WAS DUE TO PROCEDURAL TECHNIQUE (DEVICES NOT PROPERLY SUPPORTED OR COAXIALLY ALIGNED) DURING ADVANCEMENT, AS RESISTANCE WAS NOTED, ULTIMATELY CAUSING THE REPORTED SHAFT BREAK; HOWEVER, 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: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.5X33MM XIENCE SKYPOINT STENT WAS IMPLANTED HOWEVER DURING POST DILATATION WITH A 3.50X8MM NC TREK BALLOON, UPON EXPANDING THE PROXIMAL AREA OF THE STENT, A PERFORATION OCCURRED AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. IT WAS DETERMINED THAT THERE WAS A CALCIUM NODULE THAT MAY HAVE BEEN IMPACTED THE EXPANSION OF THE STENT. A 4.0X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE GUIDE LINER AND THE SHAFT BROKE. THE SDS WAS SIMPLY REMOVED AND 3.50X19MM GRAFTMASTER WAS IMPLANTED ALONG WITH BALLOON INFLATIONS TO COMPLETE THE PROCEDURE AND SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE; HOWEVER THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. 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.

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.5X33MM XIENCE SKYPOINT STENT WAS IMPLANTED HOWEVER DURING POST DILATATION WITH A 3.50X8MM NC TREK BALLOON, UPON EXPANDING THE PROXIMAL AREA OF THE STENT, A PERFORATION OCCURRED AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. IT WAS DETERMINED THAT THERE WAS A CALCIUM NODULE THAT MAY HAVE BEEN IMPACTED THE EXPANSION OF THE STENT. A 4.0X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE GUIDE LINER AND THE SHAFT BROKE. THE SDS WAS SIMPLY REMOVED AND 3.50X19MM GRAFTMASTER WAS IMPLANTED ALONG WITH BALLOON INFLATIONS TO COMPLETE THE PROCEDURE AND SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE; HOWEVER THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.