GRAFTMASTER

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: MEDICAL DEVICE PROBLEM CODE 2017- ABOVE RBP, USE AFTER EXPIRATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.8X16 MM GRAFTMASTER COVERED STENT, WHICH WAS EXPIRED, WAS IMPLANTED AT 18 ATMOSPHERES, FUNCTIONED AS INTENDED, AND SEALED THE PERFORATION. THERE WAS PERICARDIAL EFFUSION DUE TO THE PERFORATION, AND THE PATIENT WAS PLACED ON IMPELLA PUMP. PERICARDIOCENTESIS WAS PERFORMED DUE TO THE EFFUSION AND THE PATIENT WAS TRANSFERRED TO A TERTIARY CARE CENTER. THE PATIENT ULTIMATELY EXPIRED AT THE OTHER HOSPITAL, DUE TO CARDIOGENIC SHOCK. THE PHYSICIAN STATED THAT THE GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE EFFECTS, COMPLICATIONS OR THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED BY THE ACCOUNT THAT ALTHOUGH THE DEVICE WAS EXPIRED, IT WAS USED AS IT WAS THE ONLY DEVICE THE ACCOUNT HAD AT THE TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

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. THE INVESTIGATION DETERMINED THE REPORTED DEVICE EXPIRATION ISSUE AND INFLATION ABOVE INSTRUCTIONS FOR USE RATED BURST PRESSURE APPEARS TO BE RELATED TO THE USE ERROR. THE 2.8X16 MM GRAFTMASTER COVERED STENT, WHICH WAS EXPIRED, WAS IMPLANTED AT 18 ATMOSPHERES, FUNCTIONED AS INTENDED, AND SEALED THE PERFORATION. A REVIEW OF THE GRAFTMASTER LABEL ATTACHED TO THE LOT HISTORY RECORD FOR THIS LOT WAS CONDUCTED INDICATING A MANUFACTURING DATE OF 31-MAY-2022 WITH AN EXPIRATION DATE (USE BY DATE) OF 30-APRIL-2024. THE PRODUCT WAS USED AFTER EXPIRATION AS IT WAS REPORTED THE PROCEDURE OCCURRED ON (B)(6) 2024. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR STERILITY, EFFICACY, AND PERFORMANCE OF THE DEVICE. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, DOMESTIC INSTRUCTIONS FOR USE, STATES TO NOTE THE PRODUCT USE BY DATE SPECIFIED ON THE PACKAGE. ADDITIONALLY, IT ALSO SPECIFIES THE RATED BURST PRESSURE (RBP) IS 16 ATM AND CLEARLY STATES NOT TO EXCEED THE RBP. IN THIS CASE, THE IFU DEVIATIONS DID NOT CONTRIBUTE TO AN ADVERSE EVENT/PATIENT EFFECT. 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. B5: DESCRIBE EVENT OR PROBLEM: UPDATED.