BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGIFLO HAEMOSTATIC MATRIX (UNKNOWN PRODUCT CODE)

    MDR report key: 9178889 · Received October 11, 2019

    Report

    Report Number
    3008478369-2019-00007
    Event Type
    Death
    Date Received
    October 11, 2019
    Report Date
    October 11, 2019
    Manufacturer
    FERROSAN MEDICAL DEVICES
    Product Code
    LMF
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO: FDA MDR MANDATORY REPORTING. FROM: (B)(4) / FERROSAN MEDICAL DEVICES A/S. DATE: (B)(6) 2019. OUR REF: (B)(4). INITIAL AND FINAL MEDICAL DEVICE REPORTING AN ADVERSE EVENT. PLEASE RECEIVE THIS LETTER AS THE INITIAL AND FINAL REPORTING OF AN ADVERSE EVENT THAT HAS HAPPENED IN (B)(6). EVENT DESCRIPTION: THIS ADVERSE EVENT ARISES FROM THE FOLLOWING PUBLICATION: BACHOFEN, B. ET AL., SEVERE COMPLICATIONS AFTER INTRAVASCULAR APPLICATION OF BONE CEMENT AND HEMOSTATIC AGENT DURING POSTERIOR SPINAL SURGERY, 2019 HELLENIC SOCIETY OF VASCULAR AND ENDOVASCULAR SURGERY PUBLISHED BY ROTONDA PUBLICATIONS: 143-145. THE AUTHORS ARE FROM (B)(6). THE ARTICLE DESCRIBES THREE CASES: PATIENT 1 ((B)(4)) WHERE SURGIFLO¿ HAEMOSTATIC MATRIX (KIT WITH THROMBIN) AND TRAUMASTEM WERE USED TO CONTROL THE BLEEDING. PATIENT 2 ((B)(4)) WHERE SURGIFLO¿ HAEMOSTATIC MATRIX (KIT WITH THROMBIN), TACHOSIL® AND BONE CEMENT WERE USED. PATIENT 3 WHERE BONE CEMENT WAS USED. THIS REPORT CONCERNS PATIENT 2: A (B)(6) FEMALE PATIENT WITH CHRONIC OCCLUSION OF BOTH SUPERFICIAL FEMORAL ARTERIES REQUIRED EXTENDED RE-DECOMPRESSION AT THE LEVEL OF L3-S1 WITH SPONDYLODESIS TH11-S2 AND SACRAL VERTEBROPLASTY IN PRONE POSITION DUE TO DEBILITATING LUMBAR PAIN CAUSED BY PSEUDOARTHROSIS AND SACRAL FRACTURE. MASSIVE BLEEDING OCCURRED AFTER REMOVAL OF AN OLD SCREW AND STOPPED AFTER APPLICATION OF SURGIFLO¿ (ASSUMING IT IS SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN, PRODUCT CODE MS0012) AND TACHOSIL®. ADDITIONAL BONE CEMENT WAS APPLIED IN THE DRILL HOLE FOR REINFORCEMENT OF THE NEW SCREW. AFTER EXTUBATION THE PATIENT COMPLAINED OF CONTINUOUS UNMANAGEABLE PAIN IN BOTH LEGS. COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED COMPLETE THROMBOSIS OF THE INFRARENAL AORTA AND ILIAC ARTERIES WITH INTRA-ARTERIAL PRESENCE OF AIRY THROMBUS AND BONE CEMENT. THE LEFT COMMON ILIAC ARTERY WAS PERFORATED WITH THE TIP OF A NEW SCREW. SIMULTANEOUS REVASCULARIZATION WITH BIFURCATED AORTO-BIFEMORAL GRAFT, REMOVAL OF CEMENT AND THROMBUS FROM THE GROIN AND INFRAGENUAL FEMORO-POPLITEAL BYPASSES FOLLOWED. AFTER COMPLETION OF THE PROXIMAL ANASTOMOSIS, SHUNTS WERE CONNECTED TO THE LEGS OF THE BIFURCATED GRAFT AND INSERTED IN THE RIGHT DEEP FEMORAL ARTERY AND LEFT BELOW-KNEE POPLITEAL ARTERY. MASSIVE FOAMY AIRY THROMBUS AND CEMENT WAS EXTRACTED FROM ALL OCCLUDED VESSELS. MASSIVE MUSCLE NECROSIS IN BOTH LEGS INDUCED ACUTE KIDNEY INJURY RESULTING WITH EXTREMELY INCREASED POTASSIUM LEVEL AND MALIGNANT ARRHYTHMIAS. IMMEDIATELY INITIATED HEMOFILTRATION COULD NOT CORRECT SUFFICIENTLY THE POTASSIUM BLOOD LEVEL. THE PATIENT DIED DUE TO MULTI ORGAN FAILURE ON DAY THREE POST-OPERATIVELY. EVALUATION: BASED UPON THE DESCRIPTION OF THE CASE IT SEEMS LIKELY THAT THE SURGEONS HAVE INJECTED SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN INTRAVASCULARLY. THE SURGERY WAS A RE-SURGERY FOR DECOMPRESSION DUE TO DEBILITATING LUMBAR PAIN CAUSED BY PSEUDOARTHROSIS AND SACRAL FRACTURE. AFTER REMOVAL OF AN OLD SCREW SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN, TACHOSIL® AND BONE CEMENT WERE APPLIED IN THE DRILL HOLE FOR REINFORCEMENT OF THE NEW SCREW. AFTER EXTUBATION THE PATIENT COMPLAINED OF CONTINUOUS UNMANAGEABLE PAIN IN BOTH LEGS. COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED COMPLETE THROMBOSIS OF THE INFRARENAL AORTA AND ILIAC ARTERIES WITH INTRA-ARTERIAL PRESENCE OF AIRY THROMBUS AND BONE CEMENT. THE LEFT COMMON ILIAC ARTERY WAS PERFORATED WITH THE TIP OF A NEW SCREW. SIMULTANEOUS REVASCULARIZATION WITH BIFURCATED AORTO-BIFEMORAL GRAFT, REMOVAL OF CEMENT AND THROMBUS FROM THE GROIN AND INFRAGENUAL FEMORO-POPLITEAL BYPASSES FOLLOWED. THE AUTHORS NOTE THAT "MISPLACED SCREWS WITH POTENTIAL VESSEL INVOLVEMENT REMAIN CLINICALLY SILENT. RE-DO SURGERY WITH REMOVAL OR SCREW EXCHANGE HAS HIGHER RISK FOR BLEEDING COMPLICATIONS. ROUTINE CTA PRIOR TO RE-DO SPINE SURGERY WITH POSTERIOR APPROACH MIGHT HELP REVEALING MISPLACED SCREWS AND AVOID POTENTIAL VASCULAR COMPLICATIONS". THE SURGEONS HAVE USED SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN PRODUCT CODE MS0012 IN AN ABNORMAL MANNER (IMPROPER USE) AND NOT ACCORDING TO THE APPROVED INSTRUCTIONS FOR USE LABELING: CONTRAINDICATIONS: DO NOT INJECT OR COMPRESS SURGIFLO¿ INTO BLOOD VESSELS. DO NOT USE SURGIFLO¿ IN INTRAVASCULAR COMPARTMENTS BECAUSE OF THE RISK OF THROMBOEMBOLISM, DISSEMINATED INTRAVASCULAR COAGULATION, AND INCREASED RISK OF ANAPHYLACTIC REACTIONS. WARNINGS: DO NOT INJECT OR COMPRESS SURGIFLO¿ INTO BLOOD VESSELS. FOR EPILESIONAL USE ONLY. SURGIFLO¿ SHOULD NOT BE USED IN INSTANCES OF PUMPING ARTERIAL HAEMORRHAGE. IT SHOULD NOT BE USED WHERE BLOOD OR OTHER FLUIDS HAVE POOLED OR IN CASES WHERE THE POINT OF HAEMORRHAGE IS SUBMERGED. SURGIFLO¿ WILL NOT ACT AS A TAMPON OR PLUG IN A BLEEDING SITE. CONCLUSION: THE EVENT AS DESCRIBED IN THIS ADVERSE EVENT SEEMS TO HAVE A PROBABLE RELATIONSHIP WITH THE USE OF SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN AND BONE CEMENT AND THEREFORE THAT THE EVENT CANNOT REASONABLY BE EXPLAINED BY ANOTHER CAUSE. THE HARM TO THE PATIENT IS CAUSED BY USE ERROR WHERE SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN IS USED AGAINST THE CONTRAINDICATIONS AND WARNINGS AS OUTLINED IN THE INSTRUCTIONS FOR USE. THE CASE IS HEREBY CONSIDERED CLOSED.

    Description of Event or Problem · 1

    OUR REF. NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977073 SURGIFLO HAEMOSTATIC MATRIX (UNKNOWN PRODUCT CODE) SURGIFLO¿ HAEMOSTATIC MATRIX (UNKNOWN PRODUCT CODE) LMF FERROSAN MEDICAL DEVICES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death