BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTOFIX PATCH - 6CM X 8CM

    MDR report key: 21001066 · Received December 23, 2024

    Report

    Report Number
    1063481-2024-00029
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 20, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ARTIVION, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K172085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.

    Additional Manufacturer Narrative · 0

    ACCORDING TO INITIAL REPORTS SURGEON REPORTED EVENTS OF THROMBOSIS. ADDITIONAL INFORMATION FROM THE SURGEON. "FREQUENT EARLY GRAFT THROMBOSIS IN THE LAST FEW MONTHS. I HAVE TRIED HAVING PTS ON 81 AND 325 MG ASPIRIN BUT DIDN'T HELP. I REALIZE OVER TIME, THIS CAN HAPPEN, BUT THESE HAVE BEEN WITHIN 3 MONTHS FROM SURGERY" THE PRODUCT WAS IMPLANTED AND WILL NOT BE RETURNED. PATIENT IMPACT WAS SURGICAL INTERVENTION. THIS INVESTIGATION IS RELEGATED TO PFP6X8 LOT NUMBER 11052224 FOR SUSPECTED OCCLUSION OF THE MAIN PORTAL VEIN RECONSTRUCTION, OCCLUDED OR MINIMAL FLOW THROUGH THE SPLENIC VEIN, PROBABLE OCCLUSION OF THE SUPERIOR MESENTERIC VEIN AT THE CONFLUENCE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. ¿PATIENT #2: SURGERY [IMPLANT] DATE: (B)(6)2024. PRODUCT INFORMATION: TISSUE PERICARDIUM 6X8CM PHOTOFIX BOVINE LOG4515042 CRYOLIFE INC LOT NO.: 11052224 MODEL: PFP 6X8 EXP [EXPIRATION] DATE: 5/18/2026. PROCEDURE: STAGING LAPAROSCOPY, LAPAROSCOPIC FALCIFORM PERITONEAL NODULE EXCISION, LAPAROSCOPIC SEGMENT III SUB-SEGMENTECTOMY X 2, LAPAROSCOPIC SEGMENT IVB SUB-SEGMENTECTOMY AND OPEN PANCREATICODUODENECTOMY, EN BLOCK PORTION OF SMV/PV WITH BOVINE PERICARDIUM PATCH RECONSTRUCTION. COMPLICATIONS/INTERVENTIONS: DECREASED OPACIFICATION AND DIMINUTIVE APPEARANCE OF THE BILATERAL PORTAL VEINS WITH SUSPECTED OCCLUSION OF THE MAIN PORTAL VEIN RECONSTRUCTION, OCCLUDED OR MINIMAL FLOW THROUGH THE SPLENIC VEIN, PROBABLE OCCLUSION OF THE SUPERIOR MESENTERIC VEIN AT THE CONFLUENCE NOTED (B)(6) 2024. BEGAN HEPARIN DRIP AND THEN TRANSITIONED TO THERAPEUTIC LOVNEOX. REQUIRED HEPATIC DRAIN PLACEMENT FOR LIVER ABSCESS. MEDICAL HISTORY PRIOR TO SURGERY: PANCREATIC CANCER, ARTHRITIS, ASTHMA, DEPRESSION, GERD, GOUT, HYPERTENSION, HYPERLIPIDEMIA PATIENT STATUS: ALIVE.¿ ONE OTHER EVENT WAS REPORTED AND IS BEING INVESTIGATED IN COMPLAINT (B)(4). THE MANUFACTURING RECORDS FOR THE PFP6X8 LOT NUMBER 11052224 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. PER THE INITIAL INQUIRY BY THE SURGEON, PHOTOFIX PATCH DOES NOT REQUIRE ANY RINSING PRIOR TO IMPLANTATION OF THE DEVICE. ADDITIONALLY, ARTIVION DOES NOT MAKE ANY RECOMMENDATIONS RELATED TO POST-OPERATIVE ANTICOAGULATION/ANTIPLATELET MANAGEMENT. THE ADDITIONAL INFORMATION PROVIDED FOR THIS FILE HAS BEEN REVIEWED. GIVEN THE COMPLEX MEDICAL HISTORY OF THE PATIENT AND THE LACK OF SPECIFIC DIAGNOSTIC IMAGING OF THE LOCATION OF THE REPORTED NARROWING AND THROMBUS FORMATION, A DIRECT CORRELATION OF THESE EVENTS AND THE USAGE OF THE PHOTOFIX PATCH CANNOT BE SUPPORTED AT THIS TIME. THE PATCH REMAINS IMPLANTED PER ALL INFORMATION PROVIDED ABOVE; SO, NO PRODUCT WAS RETURNED FOR INTERNAL EVALUATION. DEVICE LABELING WAS ALSO REVIEWED AND FOUND TO BE SUFFICIENT WITH THE USE OF THE PHOTOFIX PATCH. NO FURTHER ACTION REQUIRED. A COMPLAINT AND RECALL QUERY WAS PERFORMED FOR PFP6X8 LOT NUMBER 11052224 TO IDENTIFY PREVIOUSLY REPORTED COMPLAINTS OR RECALLS ASSOCIATED WITH THIS LOT NUMBER. NO COMPLAINTS OR RECALLS WERE IDENTIFIED FOR THIS LOT NUMBER. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. THE MANUFACTURING RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.

    Description of Event or Problem · 0

    ACCORDING TO INITIAL REPORTS "SURGEON HAD A FEW EARLY THROMBOSIS LATELY. INQUIRED ABOUT SPECIFIC ANTICOAGULATION. SURGEON HAS BEEN PRESCRIBING EITHER 81 OR 325 ASPIRIN. " THE PRODUCT WAS IMPLANTED AND WILL NOT BE RETURNED. THIS INVESTIGATION IS RELEGATE TO PFP6X8 LOT NUMBER 11052224 FOR SUSPECTED [THROMBOSIS] OCCLUSION OF THE MAIN PORTAL VEIN RECONSTRUCTION, OCCLUDED OR MINIMAL FLOW THROUGH THE SPLENIC VEIN, PROBABLE OCCLUSION OF THE SUPERIOR MESENTERIC VEIN AT THE CONFLUENCE. ADDITIONAL INFORMATION RECEIVED. SURGERY [IMPLANT] DATE: (B)(6) 2024. PRODUCT INFORMATION: TISSUE PERICARDIUM 6X8CM PHOTOFIX BOVINE LOG4515042. CRYOLIFE INC LOT NO.: 11052224 MODEL: PFP 6X8 EXP DATE: 5/18/2026. PROCEDURE: STAGING LAPAROSCOPY, LAPAROSCOPIC FALCIFORM PERITONEAL NODULE EXCISION, LAPAROSCOPIC SEGMENT III SUB-SEGMENTECTOMY X 2, LAPAROSCOPIC SEGMENT IVB SUB-SEGMENTECTOMY AND OPEN PANCREATICODUODENECTOMY, EN BLOCK PORTION OF SMV/PV WITH BOVINE PERICARDIUM PATCH RECONSTRUCTION. COMPLICATIONS/INTERVENTIONS: DECREASED OPACIFICATION AND DIMINUTIVE APPEARANCE OF THE BILATERAL PORTAL VEINS WITH SUSPECTED OCCLUSION OF THE MAIN PORTAL VEIN RECONSTRUCTION, OCCLUDED OR MINIMAL FLOW THROUGH THE SPLENIC VEIN, PROBABLE OCCLUSION OF THE SUPERIOR MESENTERIC VEIN AT THE CONFLUENCE NOTED (B)(6) 2024. BEGAN HEPARIN DRIP AND THEN TRANSITIONED TO THERAPEUTIC LOVNEOX. REQUIRED HEPATIC DRAIN PLACEMENT FOR LIVER ABSCESS. MEDICAL HISTORY PRIOR TO SURGERY: PANCREATIC CANCER, ARTHRITIS, ASTHMA, DEPRESSION, GERD, GOUT, HYPERTENSION, HYPERLIPIDEMIA. PATIENT STATUS: ALIVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79643 PHOTOFIX PATCH - 6CM X 8CM PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ ARTIVION, INC. PFP 6X8 11052224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L