BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFLO¿ HAEMOSTATIC MATRIX (UNKNOWN PRODUCT CODE)

    MDR report key: 9174561 · Received October 10, 2019

    Report

    Report Number
    3008478369-2019-00006
    Event Type
    Injury
    Date Received
    October 10, 2019
    Report Date
    October 10, 2019
    Manufacturer
    FERROSAN MEDICAL DEVICES A/S
    Product Code
    LMF
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THE SWITZERLAND. 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 BERN HOSPITAL IN SWITZERLAND. THE ARTICLE DESCRIBES THREE CASES: PATIENT 1 (QN (B)(4)) WHERE SURGIFLO¿ HAEMOSTATIC MATRIX (KIT WITH THROMBIN) AND TRAUMASTEM WERE USED TO CONTROL THE BLEEDING. PATIENT 2 (QN (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 1: A 56-YEAR OLD FEMALE PATIENT UNDERGOES A RE-DO DECOMPRESSION DUE TO RE-STENOSIS OF THE NEURAL FORAMEN L3-L4 WITH LEFT-SIDED RADICULAR LEG PAIN. AFTER DECOMPRESSION VIA POSTERIOR APPROACH IN PRONE POSITION, MASSIVE BLEEDING STARTED FROM A RIGHT-SIDED PEDICLE SCREW HOLE AFTER REMOVAL OF AN OLD SCREW. SURGIFLO¿ (ASSUMING THAT IT IS SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN, PRODUCT CODE MS0012) AND TRAUMASTEM® WERE USED TO CONTROL THE BLEEDING. AFTER COMPLETION OF THE PROCEDURE THE PATIENT HAD RIGHT-SIDED ACUTE LOWER LIMB ISCHEMIA. COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY (CIA) WITH INTRA-ARTERIAL AIR. THE EMPTY SCREW HOLE HAD REACHED THE RIGHT CIA. IMMEDIATE BALLOON-EMBOLECTOMY OF THE ILIAC AND FEMORAL VESSELS FROM THE GROIN RESTORED CIRCULATION TO THE LEG. FOAMY LOOKING TICK (THICK) THROMBUS WAS REMOVED. INTRAOPERATIVE ANGIOGRAPHY SHOWED NO BLEEDING FROM THE ILIAC VESSEL AND EXTENSIVE EMBOLIZATION OF MULTIPLE SMALL ARTERIES IN THE LEG. THE PATIENT WAS DISCHARGED WITH SINGLE ANTIPLATELET THERAPY. AFTER ONE YEAR ALL VESSELS IN THE RIGHT LEG WERE PATENT AND THE PEDAL PULSES PALPABLE BUT THE PATIENT REPORTED SEVERE CLAUDICATION IN THE LEG. 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 RE-STENOSIS. COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY (CIA) WITH INTRA-ARTERIAL AIR. THE EMPTY SCREW HOLE REACHED THE RIGHT CIA. THE SURGEONS HAD NOT SEEN THAT THERE WAS AN INJURY INTO THE CIA AND HAD INJECTED SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN INTO THE ARTERY. AFTER COMPLETION OF THE PROCEDURE THE PATIENT HAD RIGHT-SIDED ACUTE LOWER LIMB ISCHEMIA. IMMEDIATE BALLOON-EMBOLECTOMY OF THE ILIAC AND FEMORAL VESSELS FROM THE GROIN RESTORED CIRCULATION TO THE LEG. "FOAMY LOOKING TICK (THICK) THROMBUS WAS REMOVED". 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 THEREFORE THAT THE EVENT CANNOT REASONABLY BE EXPLAINED BY ANOTHER CAUSE. THE HARM TO THE PATIENT IS CAUSED BY USE ERROR WHERE PRODUCT IS USED AGAINST THE CONTRAINDICATIONS AND WARNINGS AS OUTLINED IN THE INSTRUCTIONS FOR USE. THE CASE IS HEREBY CONSIDERED CLOSED. KIND REGARDS, (B)(4).

    Description of Event or Problem · 1

    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 BERN HOSPITAL IN SWITZERLAND. THE ARTICLE DESCRIBES THREE CASES: PATIENT 1 (QN (B)(4)) WHERE SURGIFLO¿ HAEMOSTATIC MATRIX (KIT WITH THROMBIN) AND TRAUMASTEM WERE USED TO CONTROL THE BLEEDING. PATIENT 2 (QN (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 1: A 56-YEAR OLD FEMALE PATIENT UNDERGOES A RE-DO DECOMPRESSION DUE TO RE-STENOSIS OF THE NEURAL FORAMEN L3-L4 WITH LEFT-SIDED RADICULAR LEG PAIN. AFTER DECOMPRESSION VIA POSTERIOR APPROACH IN PRONE POSITION, MASSIVE BLEEDING STARTED FROM A RIGHT-SIDED PEDICLE SCREW HOLE AFTER REMOVAL OF AN OLD SCREW. SURGIFLO¿ (ASSUMING THAT IT IS SURGIFLO¿ HAEMOSTATIC MATRIX KIT WITH THROMBIN, PRODUCT CODE MS0012) AND TRAUMASTEM® WERE USED TO CONTROL THE BLEEDING. AFTER COMPLETION OF THE PROCEDURE THE PATIENT HAD RIGHT-SIDED ACUTE LOWER LIMB ISCHEMIA. COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY (CIA) WITH INTRA-ARTERIAL AIR. THE EMPTY SCREW HOLE HAD REACHED THE RIGHT CIA. IMMEDIATE BALLOON-EMBOLECTOMY OF THE ILIAC AND FEMORAL VESSELS FROM THE GROIN RESTORED CIRCULATION TO THE LEG. FOAMY LOOKING TICK (THICK) THROMBUS WAS REMOVED. INTRAOPERATIVE ANGIOGRAPHY SHOWED NO BLEEDING FROM THE ILIAC VESSEL AND EXTENSIVE EMBOLIZATION OF MULTIPLE SMALL ARTERIES IN THE LEG. THE PATIENT WAS DISCHARGED WITH SINGLE ANTIPLATELET THERAPY. AFTER ONE YEAR ALL VESSELS IN THE RIGHT LEG WERE PATENT AND THE PEDAL PULSES PALPABLE BUT THE PATIENT REPORTED SEVERE CLAUDICATION IN THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967909 SURGIFLO¿ HAEMOSTATIC MATRIX (UNKNOWN PRODUCT CODE) SURGIFL HAEMOSTATIC MATRIX (UNKNOWN PRODUCT CODE) LMF FERROSAN MEDICAL DEVICES A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other