BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERI-GUARD PERICARDIUM WITH APEX PROCESSING

    MDR report key: 3610671 · Received February 6, 2014

    Report

    Report Number
    2032282-2014-00030
    Event Type
    Death
    Date Received
    February 6, 2014
    Date of Event
    March 28, 2012
    Report Date
    January 27, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K983162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. NO SAMPLE OR LOT NUMBER WAS PROVIDED THEREFORE THE SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. NO TREND WAS IDENTIFIED. PER SYNOVIS, NO FURTHER INVESTIGATION IS NECESSARY AS IT IS IMPOSSIBLE TO DETERMINE IF PERI-GUARD PATCH CONTRIBUTED TO THE COMPLICATION EXPERIENCED WITH THE PATIENT. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST UNDER CARDIOPULMONARY BYPASS A HIGHLY MALIGNANT HEART/VASCULAR TUMOR HAS BEEN RESECTED IN A (B)(6) YEAR OLD BOY. THE EXCISED MASS WAS 14 X 8, AND 5 X 6 CM (FIG. 2B) AND INCLUDED THREE-QUARTERS OF THE RIGHT ATRIUM, THE ATRIAL SEPTUM WITH A SMALL PART OF THE LEFT ATRIUM, THE SUPRADIAPHRAGMATIC PORTION OF THE INFERIOR VENA CAVA (IVC), AND THE ADJACENT PERICARDIUM. RECONSTRUCTION FOLLOWED, USING AUTOLOGOUS PERICARDIUM TO REBUILD THE RIGHT HEMIDIAPHRAGM, THE LEFT ATRIUM AND THE ATRIAL SEPTUM; PERI-GUARD COLLAGEN PATCH HAS BEEN USED TO REPAIR THE IVC. THE REST OF THE PERI-GUARD PATCH HAS BEEN USED TO RECONSTRUCT THE RIGHT ATRIUM. THE TUMOR HAS BEEN CONFIRMED AS A HIGHLY MALIGNANT, INVASIVE MONOPHASIC SYNOVIAL SARCOMA OF THE MEDIASTINUM. PATIENT HAD A LONG POSTOPERATIVE PERIOD THAT WAS COMPLICATED BY DEEP VEIN THROMBOSIS AND THE PRESENCE OF THROMBUS IN THE IVC, ILIAC, AND HEPATIC VEINS, CONFIRMED BY ULTRASOUND, EVEN THOUGH THE PATIENT WAS STARTED ON LOW MOLECULAR WEIGHT HEPARIN ON THE THIRD POSTOPERATIVE DAY. A CT-SCAN REVEALED PULMONARY EMBOLISM ON BOTH LUNGS, THROMBUS FORMATION ON THE IVC, HEPATIC VEINS, LEFT RENAL ARTERY, BILATERAL ILIAC VEINS AND LARGE ASCITES, AND PLEURAL EFFUSION. AFTER APPROPRIATE TREATMENT, THE REST OF HIS HOSPITAL STAY WAS UNEVENTFUL AND HE WAS DISCHARGED ON THE 33RD POSTOPERATIVE DAY WITH AN URGENT REFERRAL TO AN ONCOLOGIST. THE PATIENT AND HIS PARENTS REFUSED FURTHER CONSULTATION WITH THE ONCOLOGIST AND - ALTHOUGH THERE WAS NO RECURRENCE AT 12 MONTHS FOLLOWING THE PROCEDURE - AT 24 MONTHS THE TREATING SURGEON HAS BEEN INFORMED OF HIS DEATH, DUE TO A TUMOR APPEARING THIS TIME ON THE LEFT CARDIAC CHAMBERS, WITH SUBSEQUENT MULTI-ORGAN FAILURE. THE DEATH 24 MONTHS AFTER PRIMARY TUMOR RESECTION IS THE UNEQUIVOCAL CONSEQUENCE OF THE CANCER RECURRENCE WITH MULTI-ORGAN FAILURE AND AS A RESULT OF A MALIGNANT MEDIASTINAL TUMOR, NOT FURTHER TREATED ONCOLOGICALLY. THE SEVERE AND EXTENSIVE VENOUS THROMBOSIS IN THE IVC AND AFFERENT VEINS HAS A MULTIFACTORIAL CAUSALITY (THE INVASIVE GROWTH OF THE MALIGNANT TUMOR; THE MASSIVE MANIPULATION OF THE INNER LAYER OF THE IMPACTED VESSELS, ESPECIALLY THE IVC; AN INCREASED RISK OF THROMBOSIS AFTER SUCH EXTENSIVE CARDIO-VASCULAR PROCEDURES UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST UNDER CARDIOPULMONARY BYPASS, POTENTIALLY INSUFFICIENT HEPARINIZATION). ALTHOUGH THE COMPLICATION RATE WITH THE USE OF GLUTARALDEHYDE-PRESERVED EXTRACELLULAR MATRICES FOR INTRA-, AND EXTRA-VASCULAR CLOSURES IS RELATIVELY LOW (1-7%), COMPLICATIONS SUCH AS THROMBUS FORMATION HAVE BEEN DOCUMENTED. COLLAGEN ACTIVATES THE PLATELET SYSTEM, AND BY THAT MAY, IN CONJUNCTION WITH THE ABOVE ENUMERATED FACTORS (TRIGGER ALSO LOCAL THROMBOGENICITY). THEREFORE, WE CANNOT EXCLUDE THAT THE USE OF PERI-GUARD, AS WELL AS THE SUTURE MATERIAL/TECHNIQUE HAVE ALSO CONTRIBUTED TO THE SEVERE THROMBOEMBOLIC PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A LITERATURE ARTICLE (LOGGOS, SPIROS ET AL. "LARGE MONOPHASIC SYNOVIAL SARCOMA OF THE MEDIASTINUM IN A (B)(6) YEAR OLD BOY." INTERACTIVE CARIOVASCULAR AND THORACIC SURGERY 15 (2012) 909-911. 25 JULY 2012) THAT A PATIENT EXPERIENCED VENOUS THROMBOEMBOLISM AND PASSED AWAY 2 YEARS AFTER PERI-GUARD WAS USED. ABSTRACT: WE PRESENT THE INTERESTING CASE OF A (B)(6) YEAR OLD BOY WITH A MONOPHASIC SYNOVIAL SARCOMA (MSS) OF THE MEDIASTINUM, WHICH WAS INFILTRATING THE RIGHT HEART CHAMBERS AND THE INFERIOR VENA CAVA (IVC). A RADICAL EXCISION WAS PERFORMED, WITH EXTENSIVE RECONSTRUCTION OF THE HEART, UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST. RADICAL SURGICAL EXCISION IS CONSIDERED TO BE THE TREATMENT OF CHOICE FOR THESE LESIONS, AS CHEMOTHERAPY AND RADIOTHERAPY HAVE LITTLE EFFECT. UNFORTUNATELY, THE PATIENT AND HIS PARENTS REFUSED ANY FURTHER CONSULTATION WITH AN ONCOLOGIST AND, ALTHOUGH THERE WAS NO RECURRENCE AT 12 MONTHS FOLLOWING THE PROCEDURE, AT 24 MONTHS WE WERE INFORMED OF HIS DEATH DUE TO THE TUMOUR APPEARING ON THE LEFT CARDIAC CHAMBERS WITH SUBSEQUENT MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78341 PERI-GUARD PERICARDIUM WITH APEX PROCESSING MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death