BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER

    MDR report key: 18909486 · Received March 14, 2024

    Report

    Report Number
    2015691-2024-02024
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    June 1, 2018
    Report Date
    March 14, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED TO EDWARDS FOR EVALUATION AS THE EVENT WAS REPORTED THROUGH AN ARTICLE. BIBLIOGRAPHY: NAOUM, IBRAHIM, ET AL. 'STRATEGY FOR TOTALLY PERCUTANEOUS MANAGEMENT OF VASCULAR INJURY IN COMBINED TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT AND ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURES.' THE AMERICAN JOURNAL OF CARDIOLOGY 207 (2023): 130-136. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS, AS NEEDED. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. A PSEUDOANEURYSM IS A LEAKAGE OF ARTERIAL BLOOD FROM AN ARTERY INTO THE SURROUNDING TISSUE WITH A PERSISTENT COMMUNICATION BETWEEN THE ORIGINATING ARTERY AND THE RESULTANT ADJACENT CAVITY. THIS MAY OCCUR AFTER ARTERIAL PUNCTURE FOR A DIAGNOSTIC CARDIAC CATHETERIZATION OR AN ARTERIOGRAM BUT IS MORE COMMON AFTER AN ARTERIAL INTERVENTION. CATHETER-DIRECTED INTERVENTIONS MORE COMMONLY REQUIRE LARGER ARTERIAL SHEATHS TO BE USED, AND THE ANTICOAGULATION OR ANTIPLATELET AGENTS THAT ARE ADMINISTERED CAN INTERFERE WITH NORMAL SEALING OF THE PUNCTURE SITE. SOME PSEUDOANEURYSMS RESOLVE THEMSELVES, THOUGH OTHERS REQUIRE TREATMENT TO PREVENT HEMORRHAGE, AN UNCONTROLLED LEAK OR OTHER COMPLICATIONS. SURGERY IS SOMETIMES REQUIRED. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL/ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN 3 VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE PHYSICIAN TRAINING MANUAL ALSO LISTS THE MINIMUM RECOMMENDED VESSEL SIZE FOR EACH SIZE DEVICE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION THAT A DEVICE MALFUNCTION OCCURRED DURING THE PROCEDURE. THE CAUSE OF THE PSEUDOANEURYSM IS UNKNOWN; HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT (MANIPULATION OF THE DEVICES). OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS REPORTED THROUGH ARTICLE.

    Description of Event or Problem · 0

    AS REPORTED THROUGH A EUROPEAN JOURNAL ARTICLE, 'STRATEGY FOR TOTALLY PERCUTANEOUS MANAGEMENT OF VASCULAR INJURY IN COMBINED TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT AND ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURES'. AN ANALYZATION OF INSTITUTIONAL INTERVENTIONAL CARDIOLOGY DATABASE BETWEEN (B)(6) 2018 TO (B)(6) 2023 PERFORMED (B)(4) TOTALLY PERCUTANEOUS CONCURRENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) PROCEDURES. IN ALL CASES TAVR WAS PERFORMED FIRST TO INCREASE HEMODYNAMIC STABILITY AND WAS FOLLOWED BY EVAR. TAVR DEVICES INCLUDED EDWARDS SAPIEN 3 VALVE. THE AIM OF THIS STUDY WAS TO REPORT A COHORT OF PATIENTS WHO UNDERWENT COMBINED TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) PROCEDURES. AN 81-YEAR-OLD MALE UNDERWENT A TF-TAVI WITH A 26MM SAPIEN 3 VALVE. AFTER PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A PSEUDOANEURYSM OF THE COMMON FEMORAL ARTERY WHICH WAS SUCCESSFULLY TREATED BY ULTRASOUND-DIRECTED THROMBIN INJECTION. POSTPROCEDURAL ECHOCARDIOGRAPHY REVEALED ADEQUATE HEMODYNAMICS OF THE PROSTHETIC VALVE (A MEAN VALVULAR PRESSURE GRADIENT OF 27 MMHG WAS MEASURED WHICH WAS ATTRIBUTED TO INCREASED BLOOD FLOW ACROSS THE LEFT VENTRICULAR OUTFLOW TRACT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589607 EDWARDS EXPANDABLE INTRODUCER INTRODUCER CATHETER DYB EDWARDS LIFESCIENCES 9610ES14 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention