BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET XPEEDIOR RHEOLYLIC THROMBECTOMY SET

    MDR report key: 2467763 · Received February 15, 2012

    Report

    Report Number
    2183460-2012-00001
    Event Type
    Other
    Date Received
    February 15, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 15, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A PT REQUIRING BLOOD TRANSFUSION DUE TO BLEEDING AND ALSO HEMODYNAMIC WORSENING DURING AND POST ANGIOJET THERAPY. THE PT IS A (B)(6) MALE WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, ABDOMINAL AORTIC ANEURYSM, POST ENDOVASCULAR ANEURYSM REPAIR (EVAR), RIGHT POPLITEAL ANEURYSM (TREATED (B)(6) 2011), BILATERAL ILIAC ANEURYSM, AND RENAL INFARCTION. IN ADDITION, THE PT HAD PREVIOUSLY HAD PLACEMENT OF STENTS IN THE RIGHT POPLITEAL AND SUPERFICIAL FEMORAL ARTERY (SFA) ARTERIES ON (B)(6) 2012. THE PT WAS ADMITTED ON (B)(6) 2012, FOR SEVERE PAIN IN THE RIGHT CALF AND FOOT. ON (B)(6) 2012, THE PT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE OCCLUSION OF THE RIGHT SFA AND POPLITEAL ARTERIES. THE INTERVENTIONAL PROCEDURE INCLUDED PLACEMENT OF AN EMBOLIC PROTECTION DEVICE FOLLOWED BY ANGIOJET POWER PULSE SPRAY WITH AN ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET USING 20 MG OF ACTIVASE WITH A WAIT TIME OF 22 MINUTES. ANGIOJET THROMBECTOMY WAS THEN PERFORMED WITH THE XPEEDIOR DEVICE WITH A TOTAL RUN TIME OF 5.5 MINUTES. ASPIRATION THROMBECTOMY WAS ALSO PERFORMED WITH A MEDTRONIC EXPORT ASPIRATION CATHETER FROM THE POPLITEAL TO THE FOOT MULTIPLE TIMES. THIS WAS FOLLOWED BY MULTIPLE BALLOON ANGIOPLASTIES AND STENT PLACEMENTS. THE PHYSICIAN REPORTED NO RESIDUAL THROMBOSIS. THE PROCEDURE LASTED APPROXIMATELY 3 HOURS AND 45 MINUTES. ON (B)(6) 2012, THE PT UNDERWENT A SECOND INTERVENTION THIS TIME FOR THE LOWER LEFT EXTREMITY. THIS INTERVENTION INCLUDED PATHWAY MEDICAL TECHNOLOGIES (BAYER) JETSTREAM ATHERECTOMY X3, ANGIOJET POWER PULSE SPRAY WITH AN ANGIOJET ULTRA XPEEDIOR AND DVX THROMBECTOMY SETS USING 20 MG ACTIVASE X2, ANGIOJET THROMBECTOMY X15 AND MULTIPLE BALLOON ANGIOPLASTIES. DOCUMENTED ANGIOJET RUN TIME USE WAS AT LEAST 29 MINUTES WITH 2 RUNS WHERE RUN TIME WAS NOT RECORDED. DURING THE SIXTH HOUR OF THE PROCEDURE, THE PT WORSENED HEMODYNAMICALLY. THE PHYSICIAN STATED "HE (PT) HAD AN EXPANDING HEMATOMA IN THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE WHICH WAS SIGNIFICANT. HE HAD SYSTOLIC BLOOD PRESSURE IN THE 80-90 RANGE, SOME TACHYCARDIA, AND DECREASED PULSE PRESSURE. AFTER PROLONGED ATTEMPTS, THERE WAS NO SIGNIFICANT FLOW, BUT CONTINUED COLLATERALS TO THE PROFUNDA SYSTEM AND LEFT LEG. THE OVERALL RISK BENEFIT RATIO WAS FELT TO FAVOR FINDING THE BLEEDING SOURCE AND TERMINATING THE PROCEDURE." THE PROCEDURE LASTED APPROXIMATELY 9 HOURS. POST PROCEDURE, THE PT WAS TREATED WITH AGGRESSIVE INTRAVENOUS (IV) FLUID HYDRATION AND NEOSYNEPHRINE AND BICARB FOR TACHYCARDIA. THE PRE-PROCEDURAL HEMOGLOBIN (HGB) ON (B)(6) 2012, WAS 11.0 G/DL. THE POST PROCEDURE HGB ON (B)(6) 2012, WAS 8.4 G/DL. THE PT WAS TRANSFUSED 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS). THE PHYSICIAN RECORDED IN THE PT'S REPORT THAT THE PT DEVELOPED "SIGNIFICANT HEMODYNAMIC COMPROMISE FELT SECONDARY TO BLOOD LOSS AND BYPRODUCTS OF RHEOLYTIC THROMBECTOMY WITH INTRAVASCULAR HEMOLYSIS." THE HEMOGLOBIN HAD STABILIZED HEMODYNAMICALLY WITH A HGB OF 10.4 G/DL UPON DISCHARGE ON (B)(6) 2012. THE NOTED TOTAL ANGIOJET RUN TIME FOR THE PROCEDURE ON (B)(6) 2012, OF AT LEAST 29 MINUTES WITH TWO RUNS TIMES NOT RECORDED WAS EXCESSIVE BASED ON THE IFU RECOMMENDATIONS OF NOT EXCEEDING 5 MINUTES IN A FLOWING BLOOD FIELD AND 10 MINUTES TOTAL FOR THE ANGIOJET XPEEDIOR DEVICE AND 4 MINUTES IN A FLOWING BLOOD FIELD AND 8 MINUTES TOTAL FOR THE ANGIOJET DVX DEVICE. IN ADDITION, THE DOCUMENTATION DOES NOT SHOW IF THE PT WAS HYDRATED PRIOR TO OR DURING THE PROCEDURE. THE ANGIOJET IFU WARNS: "LARGE THROMBUS BURDENS IN PERIPHERAL VEINS AND OTHER VESSELS MAY RESULT IN SIGNIFICANT HEMOGLOBINEMIA WHICH SHOULD BE MONITORED FOR POSSIBLE RENAL, PANCREATIC OR OTHER ADVERSE EVENTS." "OPERATION OF THE ANGIOJET SYSTEM CAUSES TRANSIENT HEMOLYSIS WHICH MAY MANIFEST AS HEMOGLOBINURIA. IT IS RECOMMENDED THAT THE CATHETER OPERATION NOT EXCEED (XPEEDIOR: 5 MINUTES IN A FLOWING BLOOD FIELD AND 10 MINUTES TOTAL; DVX: 4 MINUTES IN A FLOWING BLOOD FIELD AND 8 MINUTES TOTALS). EVALUATE THE PT'S RISK TOLERANCE FOR HEMOGLOBINEMIA PRIOR TO THE PROCEDURE. CONSIDER HYDRATION PRIOR TO, DURING, AND AFTER THE PROCEDURE AS APPROPRIATE TO THE PTS OVERALL MEDICAL CONDITION." THE PT'S EXTENSIVE MEDICAL HISTORY INCLUDING RECENT TREATMENT FOR A RIGHT POPLITEAL ANEURYSM ON (B)(6) 2011 AND STENT PLACEMENT IN THE RIGHT POPLITEAL AND SFA ON (B)(6) 2012, AS WELL AS A SLIGHTLY LOW HEMOGLOBIN PRIOR TO THE PROCEDURE ON (B)(6) 2012 MAY HAVE COMPROMISED THE PT OVERALL HEALTH AND SUBSEQUENTLY HAVING HEMODYNAMIC WORSENING AND REQUIREMENT FOR BLOOD TRANSFUSION. EXCESSIVE ANGIOJET RUN TIMES CAN POTENTIALLY LEAD TO TRANSIENT HEMOLYSIS AS DESCRIBED IN THE PRODUCT IFU. HOWEVER, BASED ON THE INFORMATION AVAILABLE, THE CAUSE OR CONTRIBUTING FACTOR TO THE PT'S ADVERSE EVENTS RELATED TO ANGIOJET TREATMENT CANNOT BE CONCLUSIVELY RULED OUT AND THUS THIS EVENT IS CONSIDERED REPORTABLE. A NUMBER OF EVENTS MAY HAVE CONTRIBUTED TO THE PT REQUIRING A BLOOD TRANSFUSION AND COMPROMISED HEMODYNAMICS. THESE EVENTS INCLUDE: THE PT'S EXTENSIVE MEDICAL HISTORY INCLUDING RECENT TREATMENT FOR A RIGHT POPLITEAL ANEURYSM ON (B)(6) 2011 AND STENT PLACEMENT IN THE RIGHT POPLITEAL AND SFA ON (B)(6) 2012; A SLIGHTLY LOW HEMOGLOBIN PRIOR TO THE PROCEDURE ON (B)(6) 2012; AND THE AMOUNT OF THE CONTRAST THE PT MAY HAVE RECEIVED DURING THESE PROCEDURES. THE PT RECEIVED 267 MLS OF CONTRAST ON THE (B)(6) 2012 PROCEDURE. IT IS NOT KNOWN HOW MUCH CONTRAST THE PT RECEIVED ON THE RECENT PROCEDURES OF (B)(6) 2011 AND (B)(6) 2012, AS WELL AS THE 9 HOUR PROCEDURE ON (B)(6) 2012. EXCESSIVE ANGIOJET RUN TIMES CAN POTENTIALLY LEAD TO TRANSIENT HEMOLYSIS WITHOUT THE PROPER PRECAUTIONS AS DESCRIBED IN THE PRODUCT IFU. HOWEVER, BASED ON THE INFORMATION AVAILABLE, THE CAUSE OR CONTRIBUTING FACTOR TO THE PT'S ADVERSE EVENTS RELATED TO ANGIOJET TREATMENT CANNOT BE CONCLUSIVELY RULED OUT AND THUS THIS EVENT IS CONSIDERED REPORTABLE. A MEDRAD REPRESENTATIVE IS SCHEDULED TO MEET WITH THE PHYSICIAN ON (B)(6) 2012, TO REMIND THE PHYSICIAN OF THE RECOMMENDED RUN TIMES AND WARNINGS THAT ARE CONTAINED IN THE IFU.

    Description of Event or Problem · 1

    ADVERSE EVENT: BLEEDING REQUIRING TRANSFUSION AND HEMODYNAMIC WORSENING. A (B)(6) MALE WAS ADMITTED ON (B)(6) 2012, FOR SEVERE PAIN IN THE RIGHT CALF AND FOOT. MEDICAL HISTORY INCLUDED CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, ABDOMINAL AORTIC ANEURYSM, POST ENDOVASCULAR ANEURYSM REPAIR (EVAR), RIGHT POPLITEAL ANEURYSM (TREATED (B)(6) 2011), BILATERAL ILIAC ANEURYSM, AND RENAL INFARCTION. PT HAD PREVIOUSLY HAD PLACEMENT OF STENTS IN THE RIGHT POPLITEAL AND SFA ARTERIES ON (B)(6) 2012. ON (B)(6) 2012, PT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE OCCLUSION OF THE RIGHT SFA AND POPLITEAL ARTERIES. INTERVENTION INCLUDED PLACEMENT OF AN EMBOLIC PROTECTION DEVICE FOLLOWED BY AJ XPEEDIOR PPS USE WITH 20 MG OF ACTIVASE (WAIT TIME=22 MINUTES). THROMBECTOMY WAS PERFORMED FOR A TOTAL RUN TIME OF 5.5 MINUTES. ASPIRATION THROMBECTOMY WAS PERFORMED WITH THE EXPORT CATHETER FROM THE POPLITEAL TO THE FOOT MULTIPLE TIMES. THIS WAS FOLLOWED BY MULTIPLE BALLOON ANGIOPLASTIES AND STENT PLACEMENTS. PHYSICIAN REPORTED NO RESIDUAL THROMBOSIS. PROCEDURE LASTED APPROXIMATELY 3 HOURS AND 45 MINUTES. ON (B)(6) 2012, THE PT UNDERWENT A SECOND INTERVENTION FOR THE LOWER LEFT EXTREMITY. THIS INTERVENTION INCLUDED JETSTREAM ATHERECTOMY X3, AJ PPS WITH 20 MG OF ACTIVASE X2 (XPEEDIOR AND DVX CATHETERS), AJ THROMBECTOMY X15 AND MULTIPLE BALLOON ANGIOPLASTIES. DOCUMENTED ANGIOJET USE WAS AT LEAST 29 MINUTES WITH 2 RUNS WHERE RUN TIME WAS NOT RECORDED. DURING THE SIXTH HOUR OF THE PROCEDURE, THE PT WORSENED HEMODYNAMICALLY, "HE HAD A EXPANDING HEMATOMA IN THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE WHICH WAS SIGNIFICANT. HE HAD SYSTOLIC BLOOD PRESSURES IN THE 80-90 RANGE SOME TACHYCARDIA AND DECREASED PULSE PRESSURE. AFTER PROLONGED ATTEMPTS, THERE WAS NO SIGNIFICANT FLOW, BUT CONTINUED COLLATERALS TO THE PROFUNDA SYSTEM AND LEFT LEG. THE OVERALL RISK/BENEFIT RATIO WAS FELT TO FAVOR FINDING THE BLEEDING SOURCE AND TERMINATED THIS PROCEDURE." THE PROCEDURE LASTED APPROXIMATELY 9 HOURS. POST PROCEDURE, THE PT WAS TREATED WITH AGGRESSIVE IV FLUID HYDRATION AND NEO-SYNEPHRINE (TACHYCARDIA). PRE-PROCEDURE HGB ON (B)(6) 2012 WAS 11.0 G/DL. POST PROCEDURE HGB ON (B)(6) 2012 WAS 8.4 G/DL. PT WAS TRANSFUSED 2 UNITS OF PRBCS. PHYSICIAN RECORDED IN THE PT'S REPORT THAT THE PT DEVELOPED "SIGNIFICANT HEMODYNAMIC COMPROMISE FELT SECONDARY TO BLOOD LOSS AND "BYPRODUCTS" OF RHEOLYTIC THROMBECTOMY WITH INTRAVASCULAR HEMOLYSIS." HEMOGLOBIN HAD STABILIZED HEMODYNAMICALLY WITH A HGB=10.4 G/DL UPON DISCHARGE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET XPEEDIOR RHEOLYLIC THROMBECTOMY SET EMBOLECTOMY CATHETER DXE BAYER INTERVENTIONAL, INC. 105040-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention