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. THE REPORTED TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HEART FAILURE, MYOCARDIAL ISCHEMIA AND ELEVATED TROPONIN. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY AND THE LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS PRE-DILATED WITH NON-ABBOTT BALLOONS. A NON-ABBOTT DRUG ELUTING STENT WAS PLACED AND POST-DILATED AND A PERFORATION NOTED IN THE PROXIMAL LAD AND PROLONGED INFLATION WAS PERFORMED. DURING PROLONGED INFLATION THE GUIDE WIRE IN THE CIRCUMFLEX WAS INADVERTENTLY PULLED INTO THE LAD. THE PERFORATION WAS PERSISTENT SO A 2.8X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED; HOWEVER, THIS JAILED THE UNSPECIFIED GUIDE WIRE. DIRECT RETRIEVAL WITH A MICROCATHETER WAS NOT POSSIBLE, SO A MEDIAN STERNOTOMY AND CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "TCTAP C-138 EXTRA SANDWICH FILLINGS: COVERED STENT-IN-STENT WITH WIRE ENTRAPMENT IN A LEFT MAIN BIFURCATION LESION".