BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 4965207 · Received August 4, 2015

    Report

    Report Number
    9616099-2015-00341
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    March 1, 2013
    Report Date
    July 17, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANTEGRADE ACCESS SITE IN THE LEFT COMMON FEMORAL ARTERY (CFA) WAS SEALED WITH A BIO-ABSORBABLE 7F EXOSEAL VCD. AN EXPERIENCED RADIOLOGIST (>150 DEPLOYMENTS OF THE VCD) PERFORMED THE PLUG IMPLANTATION ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. DURING THE IMPLANTATION, NO PROBLEMS WITH THE SHEATH OR THE DEVICE ITSELF WERE RECOGNIZED. POST-INTERVENTIONAL DUPLEX SONOGRAPHY UNVEILED A COMPLETE OCCLUSION OF THE LEFT SFA WITH ACUTE ISCHEMIA DUE TO RELATIVELY HYPER-ECHOIC, THROMBUS-LIKE MATERIAL THE NEXT DAY. THE PATIENT REPORTED THAT HIS LEG HAD BECOME COLD IMMEDIATELY AFTER THE VCD IMPLANTATION. FORTUNATELY, THIS REOCCLUSION WAS IN THE SAME SEGMENT AS BEFORE. THEREFORE, THE PRE-EXISTING COLLATERAL VESSELS WERE ABLE TO COMPENSATE THE ISCHEMIA. AT THIS TIME, THE ATTENDING PHYSICIANS PRESUMED THAT REOCCLUSION WAS DUE TO A COMMON CAUSE LIKE EMBOLISM OR LIKEWISE. HENCE, A SECOND PERCUTANEOUS INTERVENTION SEEMED TO BE A PROMISING TREATMENT OPTION. THE FOLLOW-UP INTERVENTION TOOK PLACE 24 HOURS AFTER THE INITIAL TREATMENT AND WAS PERFORMED WITH AN 8F 11 CM STANDARD BRITE TIP SHEATH FOLLOWED BY ADMINISTRATION OF 5000 I.U. OF HEPARIN AFTER ANTEGRADE PUNCTURE OF THE LEFT CFA. THE INITIAL ANGIOGRAM CONFIRMED THE COMPLETE OCCLUSION OF THE SFA AND THE PROXIMAL PORTION OF THE POPLITEAL ARTERY (PA). THE OCCLUSION WAS TREATED STEP-WISE BY ASPIRATION THROMBECTOMY WITH AN 8F NON-CORDIS ASPIRATION CATHETER. THUS, THE PROXIMAL PARTS OF THE SFA WERE REOPENED BUT THERE WAS A NEW HARD RESISTANCE WITHIN THE DISTAL PORTION OF THE SFA STENT, WHICH COULD NOT BE PASSED WITH THE ASPIRATION CATHETER. THIS RESISTANCE WAS PROBABLY CAUSED BY THE BIOABSORBABLE PLUG OF THE VCD WHICH HAD WORKED ITSELF INTO THE STENT. FINALLY, THE HARD RESISTANCE WAS CROSSED WITH A 0.018 INCH NON-CORDIS GUIDE WIRE, AND A NON-CORDIS PROTECTION DEVICE WAS PLACED DISTALLY TO THE PLUG IN ORDER TO AVOID DISTAL EMBOLIZATION OF PLUG MATERIAL OR THROMBUS DURING FURTHER TREATMENT. THE SITE WHERE THE PLUG CAUSED THE OCCLUSION WAS DILATED WITH A 5×40 MM STANDARD BALLOON. THIS RESULTED IN THE RESTORATION OF THE BLOOD FLOW. HOWEVER, THERE WAS STILL WALL ADHERENT MATERIAL PRESENT DISTALLY TO THE SITE OF THE FORMER OCCLUSION. IN ORDER TO FIX THE PLUG AND AVOID CONSECUTIVE DISTAL EMBOLIZATION DURING THE DEGRADATION PROCESS OF THE PLUG, THE MATERIAL WAS FIXED IN THE DISTAL SFA USING A 5×60 MM NON-CORDIS SELF-EXPANDING STENT. AFTERWARDS, THE EMBOLIC PROTECTIVE DEVICE WAS RETRIEVED SUCCESSFULLY. IT WAS HALF FILLED WITH FRESH THROMBOTIC MATERIAL. PLUG MATERIAL WAS NOT PRESENT. THE FINAL ANGIOGRAM SHOWED COMPLETE RESTORATION OF BLOOD FLOW WITHOUT ANY SIGNS OF RESIDUAL STENOSIS, DISSECTION, OR DISTAL EMBOLIZATION. THE PATIENT WAS IMMEDIATELY FREE OF SYMPTOMS. THE 6-MONTH FOLLOW-UP EXAMINATION CONDUCTED BY THE PATIENTS¿ FAMILY PHYSICIAN REVEALED NO RECURRENCE OF LEG ISCHEMIA OR CLAUDICATION. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: MAXIEN ET AL (2013). ENDOVASCULAR TREATMENT OF ACUTE LIMB ISCHEMIA CAUSED BY AN INTRAVASCULARLY DEPLOYED BIOABSORBABLE PLUG OF A VASCULAR CLOSURE DEVICE. VASA,144-148. THE ARTICLE IS ATTACHED. THE CATALOG CODE PROVIDED (UNKEXOSEALOUS), REPRESENTS AN UNKNOWN EXOSEAL DEVICE SOLD OUTSIDE OF THE US. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. CONCOMITANT PRODUCTS AND DEVICES: ONE 7F SHEATH INTRODUCER (TERUMO RADIFOCUS INTRODUCER II, TERUMO EUROPE N.V., LEUVEN, BELGIUM); ONE 8F 11CM SHEATH (BRITE TIP ENDOVASCULAR SHEATH); ONE 8F ASPIRATION CATHETER (BIG LUMEN ASPIRATION CATHETER, OPTIMED MEDIZINISCHE INSTRUMENTE GMBH, ETTLINGEN, GERMANY) FOR ASPIRATION THROMBECTOMY; ONE 0.018 INCH GUIDEWIRE (V18 CONTROL WIRE®) TO CROSSED THE HARD RESISTANCE; AND BOSTON SCIENTIFIC, NATICK, PROTECTION DEVICE (SPIDER FX®, EV3 ENDOVASCULAR INC., PLYMOUTH, MN, USA) TO AVOID DISTAL EMBOLI. COMPLAINT CONCLUSION: AS REPORTED BY MAXIEN ET AL ENDOVASCULAR TREATMENT OF ACUTE LIMB ISCHEMIA CAUSED BY AN INTRAVASCULARLY DEPLOYED BIOABSORBABLE PLUG OF A VASCULAR CLOSURE DEVICE; VASA (2013) 144-148; THE PLUG HAD DEPLOYED INTRAVASCULARLY. THE NEXT DAY, INTERVENTION WAS PERFORMED TO REMOVE THE OCCLUSION. THE PATIENT WAS IMMEDIATELY FREE OF SYMPTOMS AFTER TREATMENT. A (B)(6) PATIENT WITH PERIPHERAL ARTERIAL DISEASE (PAD) AFFECTING HIS LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND HIS PROFOUND FEMORAL ARTERY (PFA) UNDERWENT BALLOON ANGIOPLASTY WITH STENTING OF THE SFA AFTER THE INSERTION OF A 7F NON-CORDIS STANDARD SHEATH. POST-PROCEDURAL ANGIOGRAPHY SHOWED A COMPLETE RESTORATION OF BLOOD FLOW IN THE SFA. THE ANTEGRADE ACCESS SITE IN THE LEFT COMMON FEMORAL ARTERY (CFA) WAS SEALED WITH A BIO-ABSORBABLE 7F EXOSEAL VCD. AN EXPERIENCED RADIOLOGIST (>150 DEPLOYMENTS OF THE VCD) PERFORMED THE PLUG IMPLANTATION ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. DURING THE IMPLANTATION, NO PROBLEMS WITH THE SHEATH OR THE DEVICE ITSELF WERE RECOGNIZED. POST-INTERVENTIONAL DUPLEX SONOGRAPHY UNVEILED A COMPLETE OCCLUSION OF THE LEFT SFA WITH ACUTE ISCHEMIA DUE TO RELATIVELY HYPER-ECHOIC, THROMBUS-LIKE MATERIAL THE NEXT DAY. THE PATIENT REPORTED THAT HIS LEG HAD BECOME COLD IMMEDIATELY AFTER THE VCD IMPLANTATION. FORTUNATELY, THIS REOCCLUSION WAS IN THE SAME SEGMENT AS BEFORE. THEREFORE, THE PRE-EXISTING COLLATERAL VESSELS WERE ABLE TO COMPENSATE THE ISCHEMIA. AT THIS TIME, THE ATTENDING PHYSICIANS PRESUMED THAT REOCCLUSION WAS DUE TO A COMMON CAUSE LIKE EMBOLISM OR LIKEWISE. HENCE, A SECOND PERCUTANEOUS INTERVENTION SEEMED TO BE A PROMISING TREATMENT OPTION. THE FOLLOW-UP INTERVENTION TOOK PLACE 24 HOURS AFTER THE INITIAL TREATMENT AND WAS PERFORMED WITH AN 8F 11 CM STANDARD BRITE TIP SHEATH FOLLOWED BY ADMINISTRATION OF 5000 I.U. OF HEPARIN AFTER ANTEGRADE PUNCTURE OF THE LEFT CFA. THE INITIAL ANGIOGRAM CONFIRMED THE COMPLETE OCCLUSION OF THE SFA AND THE PROXIMAL PORTION OF THE POPLITEAL ARTERY (PA). THE OCCLUSION WAS TREATED STEP-WISE BY ASPIRATION THROMBECTOMY WITH AN 8F NON-CORDIS ASPIRATION CATHETER. THUS, THE PROXIMAL PARTS OF THE SFA WERE REOPENED BUT THERE WAS A NEW HARD RESISTANCE WITHIN THE DISTAL PORTION OF THE SFA STENT, WHICH COULD NOT BE PASSED WITH THE ASPIRATION CATHETER. THIS RESISTANCE WAS PROBABLY CAUSED BY THE BIOABSORBABLE PLUG OF THE VCD WHICH HAD WORKED ITSELF INTO THE STENT. FINALLY, THE HARD RESISTANCE WAS CROSSED WITH A 0.018 INCH NON-CORDIS GUIDE WIRE, AND A NON-CORDIS PROTECTION DEVICE WAS PLACED DISTALLY TO THE PLUG IN ORDER TO AVOID DISTAL EMBOLIZATION OF PLUG MATERIAL OR THROMBUS DURING FURTHER TREATMENT. THE SITE WHERE THE PLUG CAUSED THE OCCLUSION WAS DILATED WITH A 5×40 MM STANDARD BALLOON. THIS RESULTED IN THE RESTORATION OF THE BLOOD FLOW. HOWEVER, THERE WAS STILL WALL ADHERENT MATERIAL PRESENT DISTALLY TO THE SITE OF THE FORMER OCCLUSION. IN ORDER TO FIX THE PLUG AND AVOID CONSECUTIVE DISTAL EMBOLIZATION DURING THE DEGRADATION PROCESS OF THE PLUG, THE MATERIAL WAS FIXED IN THE DISTAL SFA USING A 5×60 MM NON-CORDIS SELF-EXPANDING STENT. AFTERWARDS, THE EMBOLIC PROTECTIVE DEVICE WAS RETRIEVED SUCCESSFULLY. IT WAS HALF FILLED WITH FRESH THROMBOTIC MATERIAL. PLUG MATERIAL WAS NOT PRESENT. THE FINAL ANGIOGRAM SHOWED COMPLETE RESTORATION OF BLOOD FLOW WITHOUT ANY SIGNS OF RESIDUAL STENOSIS, DISSECTION, OR DISTAL EMBOLIZATION. THE PATIENT WAS IMMEDIATELY FREE OF SYMPTOMS. THE 6-MONTH FOLLOW-UP EXAMINATION CONDUCTED BY THE PATIENTS¿ FAMILY PHYSICIAN REVEALED NO RECURRENCE OF LEG ISCHEMIA OR CLAUDICATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE (IFU), USERS ARE CAUTIONED THAT SERIOUS ADVERSE EVENTS MIGHT RESULT WITH THE USE OF THE EXOSEAL VCD IN VESSELS NOT SUITABLE FOR THE USE OF THE DEVICE. DO NOT USE THE EXOSEAL VCD TO CLOSE ARTERIOTOMIES CREATED IN AREAS OF CALCIFIED PLAQUE OR STENTED SEGMENTS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW AND WITHOUT THE RETURN OF THE DEVICE, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY MAXIEN ET AL ENDOVASCULAR TREATMENT OF ACUTE LIMB ISCHEMIA CAUSED BY AN INTRAVASCULARLY DEPLOYED BIOABSORBABLE PLUG OF A VASCULAR CLOSURE DEVICE; VASA (2013) 144-148; THE PLUG HAD DEPLOYED INTRAVASCULARLY. THE NEXT DAY, INTERVENTION WAS PERFORMED TO REMOVE THE OCCLUSION. THE PATIENT WAS IMMEDIATELY FREE OF SYMPTOMS AFTER TREATMENT. A (B)(6) PATIENT WITH PERIPHERAL ARTERIAL DISEASE (PAD) AFFECTING HIS LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND HIS PROFOUND FEMORAL ARTERY (PFA) UNDERWENT BALLOON ANGIOPLASTY WITH STENTING OF THE SFA AFTER THE INSERTION OF A 7F NON-CORDIS STANDARD SHEATH. POST-PROCEDURAL ANGIOGRAPHY SHOWED A COMPLETE RESTORATION OF BLOOD FLOW IN THE SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507417 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R