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 PATIENT EFFECTS OF CARDIAC ARREST, PERICARDIAL EFFUSION AND SERIOUS INJURY/ ILLNESS/ IMPAIRMENT AND THE RELATIONSHIP TO PRODUCT IF ANY, CANNOT BE DETERMINED. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC MODEL AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. FACTORS THAT MAY CONTRIBUTE TO THE PERFORMANCE OUTCOMES LISTED IN THE ARTICLE INCLUDE, BUT ARE NOT LIMITED TO, DEVICE TO PATIENT INTERACTION, PATIENT ANATOMICAL CONDITIONS, DEVICE TO USER INTERACTION AND MANUFACTURING OR MATERIAL ISSUES. DUE TO THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE CANNOT BE DETERMINED. 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. B3, D6A: ESTIMATED DATE. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ATTACHMENT ARTICLE TITLED, "THE USE OF COVERED STENTS IN CORONARY ANEURYSMS: EFFECTIVE AND SAFE, BUT STILL NOT FDA APPROVED".

Description of Event or Problem

IT WAS REPORTED IN A CASE STUDY ARTICLE THAT GRAFTERMASTER COVERED STENT IS EFFECTIVE AND SAFE FOR USE TO TREAT CORONARY ANEURYSMS; ALTHOUGH, THE USE FOR THE GRAFTMASTER STENT IS NOT APPROVED FOR USE TO TREAT CORONARY ANEURYSMS. THE GRAFTMASTER WAS USED TO TREAT PERFORATIONS; HOWEVER, THE PATIENT EFFECTS PERICARDIAL EFFUSION AND CARDIAC ARREST WERE NOTED TO HAVE OCCURRED. ADDITIONAL INFORMATION CAN BE FOUND IN THE CASE STUDY ARTICLE, "THE USE OF COVERED STENTS IN CORONARY ANEURYSMS: EFFECTIVE AND SAFE, BUT STILL NOT FDA APPROVED". NO ADDITIONAL INFORMATION WAS PROVIDED.