BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM

    MDR report key: 14310028 · Received May 6, 2022

    Report

    Report Number
    14310028
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 19, 2022
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    PSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BACKGROUND: A GRIEVANCE WAS ENTERED RELATED TO THIS ISSUE LAST MONTH. A CARDIAC SURG PATIENT HAD A PROCEDURE ABOUT 5 YEARS AGO PERFORMED BY DR. (B)(6) DURING THIS PROCEDURE A PHOTOFIX PATCH WAS USED. THE PATIENT SUBSEQUENTLY DEVELOPED A BAFFLE LEAK AND IT WAS DISCOVERED THAT THE PATCH HAD DEGRADED. HERE IS INFO FROM THE RECORD FROM ABOUT 5 YEARS AGO ABOUT THE MATERIAL USED: INVENTORY ITEM: GRFT VASCLR STRTCH 40CM 8MM #S0804 I#51460 MODEL/CAT NUMBER: S0804, SERIAL NUMBER: (B)(4) MANUFACTURER: (B)(4) LOT NUMBER: N/A SIZE: 8 MM. LAST MONTH, DR. (B)(6) OPERATED ON THE PATIENT TO REPLACE THE DEGRADED PATCH. PER OPERATION NOTE, "AGAIN, THIS PREVIOUSLY WAS A PHOTOFIX AND WE COULD SEE THAT THERE WERE INNUMERABLE VENTRICULAR SEPTAL DEFECTS THROUGHOUT THE ENTIRE MIDDLE OF THE PATCH WITH EXTREMELY THINNED OUT PATCH MATERIAL OVER THE REMAINING INTACT PART OF THE PATCH. THERE WERE AT LEAST 5 MODERATE TO LARGE VENTRICULAR SEPTAL DEFECTS WITHIN THE PATCH MATERIAL THAT WERE IDENTIFIED. THE SUTURE LINE WAS COMPLETELY INTACT WITH NO RUPTURE OF THE SUTURE LINE OR SEPARATION OF THE EDGES OF THE PATCH FROM THE VENTRICULAR RIM OF THE VENTRICULAR SEPTAL DEFECT. THEREFORE, THIS WAS CLEARLY A PATCH DEGENERATION. WE COMPLETELY RESECTED ALL OF THE PATCH MATERIAL AND THEN REPLACED IT WITH A DACRON HEMASHIELD PATCH AND A RUNNING 3-0 PROLENE SUTURE." IN DR.(B)(6) RESPONSE TO THIS GRIEVANCE, HE INDICATED THAT SURGERY TEAM USED TO USE THIS PATCH MATERIAL CALLED PHOTOFIX. HE STATED THAT IT HAS SINCE BEEN NOTED THAT THIS MATERIAL DEGENERATES WHEN USED AS A PATCH MATERIAL IN THE HEART. THE TEAM WAS UNAWARE OF THE DEGENERATIVE PROCESS OF THIS PRODUCT WHEN IT WAS USED IN THEIR PATIENTS. HE STATED THAT THE COMPANY STATED THEY WERE UNAWARE OF THIS PROBLEM WHEN THEY PUT THE PRODUCT ON THE MARKET. HE HAS SAID THAT THE PRODUCT WAS FDA APPROVED. HE STATED THAT, TO HIS KNOWLEDGE, THE FACILITY NEVER REPORTED THIS ISSUE TO THE FDA. DR. (B)(6) STATED HE DOES NOT KNOW THE EXACT NUMBER OF PATIENTS TREATED AT THE FACILITY WITH THIS MATERIAL AND THAT OBTAINING THAT NUMBER WOULD REQUIRE A REVIEW OF THE OR DATABASE AND/OR SURGICAL DATABASE. NOTE: THE FAMILY OF THIS PATIENT IS AWARE OF THE ISSUE WITH THE PHOTOFIX PATCH AND IS FOCUSED ON FACILITY REPORTING THIS ISSUE TO THE FDA AND SHOWING THEM EVIDENCE OF THE MEDSUN REPORT. ASSESSMENT: WHILE THIS PARTICULAR PATCH DEGRADATION INCIDENT MAY NOT MEET THE SPECIFIC FDA CRITERIA FOR MANDATED REPORTING THE FDA DOES HIGHLY ENCOURAGE REPORTING OF ISSUES SUCH AS THESE. REPORTING THIS MATERIAL DEFECT IS A REASONABLE ACTION AND WOULD HELP TO SATISFY THIS PARENTS REQUEST FOR EVIDENCE THE FACILITY HAS REPORTED IT. ALSO, FINDING OUT IF THE FDA HAS PLACED ANY RECALLS OR ALERTS ON THIS PHOTOFIX PRODUCT WOULD HELP THE FACILITY TO DETERMINE IF WE NEED TO IDENTIFY THE OTHER PATIENTS WHO RECEIVED THIS PATCH TO NOTIFY THEIR CARDIOLOGISTS AND/OR FAMILIES. RECOMMENDATION: REPORT THIS MATERIAL DEFECT TO THE FDA. IDENTIFY IF THERE HAVE BEEN ANY RECALLS OR ALERTS ABOUT THIS PRODUCT THAT WOULD GUIDE THE FACILITY¿S COMMUNICATIONS WITH OTHER PATIENTS WHO HAVE POTENTIALLY BEEN IMPACTED. PLEASE NOTIFY PATIENT SAFETY AND OPE IF THERE ARE RECALLS AND/OR ALERTS RELATED TO THIS PRODUCT.

    Description of Event or Problem · 0

    BACKGROUND: A GRIEVANCE WAS ENTERED RELATED TO THIS ISSUE LAST MONTH. A CARDIAC SURG PATIENT HAD A PROCEDURE ABOUT 5 YEARS AGO PERFORMED BY DR. XX. DURING THIS PROCEDURE A PHOTOFIX PATCH WAS USED. THE PATIENT SUBSEQUENTLY DEVELOPED A BAFFLE LEAK AND IT WAS DISCOVERED THAT THE PATCH HAD DEGRADED. HERE IS INFO FROM THE RECORD FROM ABOUT 5 YEARS AGO ABOUT THE MATERIAL USED: INVENTORY ITEM: GRFT VASCLR STRTCH 40CM 8MM #S0804 I#51460 MODEL/CAT NUMBER: S0804. SERIAL NUMBER: [SN REDACTED] MANUFACTURER: W.L. GORE. LOT NUMBER: N/A SIZE: 8 MM. LAST MONTH, DR. XX OPERATED ON THE PATIENT TO REPLACE THE DEGRADED PATCH. PER OPERATION NOTE, "AGAIN, THIS PREVIOUSLY WAS A PHOTOFIX AND WE COULD SEE THAT THERE WERE INNUMERABLE VENTRICULAR SEPTAL DEFECTS THROUGHOUT THE ENTIRE MIDDLE OF THE PATCH WITH EXTREMELY THINNED OUT PATCH MATERIAL OVER THE REMAINING INTACT PART OF THE PATCH. THERE WERE AT LEAST 5 MODERATE TO LARGE VENTRICULAR SEPTAL DEFECTS WITHIN THE PATCH MATERIAL THAT WERE IDENTIFIED. THE SUTURE LINE WAS COMPLETELY INTACT WITH NO RUPTURE OF THE SUTURE LINE OR SEPARATION OF THE EDGES OF THE PATCH FROM THE VENTRICULAR RIM OF THE VENTRICULAR SEPTAL DEFECT. THEREFORE, THIS WAS CLEARLY A PATCH DEGENERATION. WE COMPLETELY RESECTED ALL OF THE PATCH MATERIAL AND THEN REPLACED IT WITH A DACRON HEMASHIELD PATCH AND A RUNNING 3-0 PROLENE SUTURE." IN DR. XX'S RESPONSE TO THIS GRIEVANCE, HE INDICATED THAT SURGERY TEAM USED TO USE THIS PATCH MATERIAL CALLED PHOTOFIX. HE STATED THAT IT HAS SINCE BEEN NOTED THAT THIS MATERIAL DEGENERATES WHEN USED AS A PATCH MATERIAL IN THE HEART. THE TEAM WAS UNAWARE OF THE DEGENERATIVE PROCESS OF THIS PRODUCT WHEN IT WAS USED IN THEIR PATIENTS. HE STATED THAT THE COMPANY STATED THEY WERE UNAWARE OF THIS PROBLEM WHEN THEY PUT THE PRODUCT ON THE MARKET. HE HAS SAID THAT THE PRODUCT WAS FDA APPROVED. HE STATED THAT, TO HIS KNOWLEDGE, THE FACILITY NEVER REPORTED THIS ISSUE TO THE FDA. DR. XX STATED HE DOES NOT KNOW THE EXACT NUMBER OF PATIENTS TREATED AT THE FACILITY WITH THIS MATERIAL AND THAT OBTAINING THAT NUMBER WOULD REQUIRE A REVIEW OF THE OR DATABASE AND/OR SURGICAL DATABASE. NOTE: THE FAMILY OF THIS PATIENT IS AWARE OF THE ISSUE WITH THE PHOTOFIX PATCH AND IS FOCUSED ON FACILITY REPORTING THIS ISSUE TO THE FDA AND SHOWING THEM EVIDENCE OF THE MEDSUN REPORT. ASSESSMENT: WHILE THIS PARTICULAR PATCH DEGRADATION INCIDENT MAY NOT MEET THE SPECIFIC FDA CRITERIA FOR MANDATED REPORTING THE FDA DOES HIGHLY ENCOURAGE REPORTING OF ISSUES SUCH AS THESE. REPORTING THIS MATERIAL DEFECT IS A REASONABLE ACTION AND WOULD HELP TO SATISFY THIS PARENTS REQUEST FOR EVIDENCE THE FACILITY HAS REPORTED IT. ALSO, FINDING OUT IF THE FDA HAS PLACED ANY RECALLS OR ALERTS ON THIS PHOTOFIX PRODUCT WILL HELP THE FACILITY TO DETERMINE IF WE NEED TO IDENTIFY THE OTHER PATIENTS WHO RECEIVED THIS PATCH TO NOTIFY THEIR CARDIOLOGISTS AND/OR FAMILIES. RECOMMENDATION: REPORT THIS MATERIAL DEFECT TO THE FDA. IDENTIFY IF THERE HAVE BEEN ANY RECALLS OR ALERTS ABOUT THIS PRODUCT THAT WOULD GUIDE THE FACILITY¿S COMMUNICATIONS WITH OTHER PATIENTS WHO HAVE POTENTIALLY BEEN IMPACTED. PLEASE NOTIFY PATIENT SAFETY AND OPE IF THERE ARE RECALLS AND/OR ALERTS RELATED TO THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078858 PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED PSQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male