JOSTENT GRAFTMASTER

Additional Manufacturer Narrative

LITERATURE ATTACHMENT: ARTICLE, TITLED "CORONARY ARTERY PERFORATION DURING PCI: MECHANISMS, MANAGEMENT, AND OUTCOMES FROM A 10-YEAR EXPERIENCE" -B3 - THE DATE OF PROCEDURE WILL BE ESTIMATED AS 6/18/2015 AS THE ARTICLE WAS RECEIVED 6/18/2025 AND THE STUDY WAS CONDUCTED OVER 10 YEARS. D6A: ESTIMATED DATE MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

THE ARTICLE DOCUMENTS CASE STUDIES OF PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURES COMPLICATED BY TYPE III CORONARY ARTERY PERFORATIONS (CAP). CASE 1 DOCUMENTS A 54 YEAR OLD PATIENT WHO PRESENTED WITH EXERTIONAL ANGINA, AND ANGIOGRAM REVEALED A COMPLEX LESION IN THE OSTIOPROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.0X16MM DRUG-ELUTING STENT (DES) WAS DEPLOYED FROM THE LEFT MAIN (LM) CORONARY ARTERY TO LAD. POST-DILATION OF THE LM TO 5MM INADVERTENTLY DILATED THE LAD OSTIUM, RESULTING IN AN ELLIS TYPE III CAP. EMERGENCY PERICARDIOCENTESIS WITH AUTOTRANSFUSION WAS PERFORMED. A 3.5X16MM GRAFTMASTER COVERED STENT (CS) WAS DEPLOYED AND POST-DILATED UP TO 4 MM. POST-STENTING ANGIOGRAPHY SHOWED NO EXTRAVASATION WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION FLOW GRADE 3 INTO THE LAD. HOWEVER, THERE WAS NO FLOW ACROSS THE LEFT CIRCUMFLEX ARTERY (LCX). THE PATIENT REMAINED HEMODYNAMICALLY STABLE DESPITE A LARGE TERRITORY OF ISCHEMIA, WITH PARTIAL FILLING OF THE DISTAL OBTUSE MARGINAL ARTERY (OMA) BRANCH FROM THE DISTAL LAD ON ANGIOGRAPHY PERFORMED 10 MINUTES AFTER CS DEPLOYMENT. ALTHOUGH FENESTRATION OF THE CS WAS CONSIDERED, THE PATIENT WAS MANAGED CONSERVATIVELY OWING TO HEMODYNAMIC STABILITY AFTER 30 MINUTES AND THE UNAVAILABILITY OF ELECTROCAUTERY AT THE TIME. THE PATIENT WAS DISCHARGED ON DAY 4 AND REMAINED WELL AT 4-YEAR FOLLOW-UP, WITH ECHOCARDIOGRAPHY SHOWING MILD SYSTOLIC DYSFUNCTION BUT NO LCX ABNORMALITY. DETAILS ARE LISTED IN THE ARTICLE TITLED, ¿CORONARY ARTERY PERFORATION DURING PCI: MECHANISMS, MANAGEMENT, AND OUTCOMES FROM A 10-YEAR EXPERIENCE ". NO ADDITIONAL INFORMATION WAS PROVIDED. DATE OF EVENT ESTIMATED: 6/18/2015

Description of Event or Problem

THE ARTICLE DOCUMENTS CASE STUDIES OF PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURES COMPLICATED BY TYPE III CORONARY ARTERY PERFORATIONS (CAP). CASE 1 DOCUMENTS A 54 YEAR OLD PATIENT WHO PRESENTED WITH EXERTIONAL ANGINA, AND ANGIOGRAM REVEALED A COMPLEX LESION IN THE OSTIOPROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.0 X 16 MM DRUG-ELUTING STENT (DES) WAS DEPLOYED FROM THE LEFT MAIN (LM) CORONARY ARTERY TO LAD. POST-DILATION OF THE LM TO 5MM INADVERTENTLY DILATED THE LAD OSTIUM, RESULTING IN AN ELLIS TYPE III CAP. EMERGENCY PERICARDIOCENTESIS WITH AUTOTRANSFUSION WAS PERFORMED. A 3.5 X 16 MM GRAFTMASTER COVERED STENT (CS) WAS DEPLOYED AND POST-DILATED UP TO 4 MM. POST-STENTING ANGIOGRAPHY SHOWED NO EXTRAVASATION WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION FLOW GRADE 3 INTO THE LAD. HOWEVER, THERE WAS NO FLOW ACROSS THE LEFT CIRCUMFLEX ARTERY (LCX). THE PATIENT REMAINED HEMODYNAMICALLY STABLE DESPITE A LARGE TERRITORY OF ISCHEMIA, WITH PARTIAL FILLING OF THE DISTAL OBTUSE MARGINAL ARTERY (OMA) BRANCH FROM THE DISTAL LAD ON ANGIOGRAPHY PERFORMED 10 MINUTES AFTER CS DEPLOYMENT. ALTHOUGH FENESTRATION OF THE CS WAS CONSIDERED, THE PATIENT WAS MANAGED CONSERVATIVELY OWING TO HEMODYNAMIC STABILITY AFTER 30 MINUTES AND THE UNAVAILABILITY OF ELECTROCAUTERY AT THE TIME. THE PATIENT WAS DISCHARGED ON DAY 4 AND REMAINED WELL AT 4-YEAR FOLLOW-UP, WITH ECHOCARDIOGRAPHY SHOWING MILD SYSTOLIC DYSFUNCTION BUT NO LCX ABNORMALITY. DETAILS ARE LISTED IN THE ARTICLE TITLED, "CORONARY ARTERY PERFORATION DURING PCI: MECHANISMS, MANAGEMENT, AND OUTCOMES FROM A 10-YEAR EXPERIENCE". NO ADDITIONAL INFORMATION WAS PROVIDED. DATE OF EVENT ESTIMATED: 6/18/2015.

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 PATIENT EFFECTS OF ISCHEMIA AND OCCLUSION ARE LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT 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.