BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER

    MDR report key: 3243824 · Received July 23, 2013

    Report

    Report Number
    2015691-2013-20659
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASCENDRA BAV CATHETER WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION. PATIENTS UNDERGOING THE TAVR PROCEDURE CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. PATIENT RISK FACTORS FOR HYPOTENSION INCLUDE LOW EF, CAD, CHF, ARTERIOSCLEROSIS, HYPOVOLEMIA, AND ANEMIA. ADDITIONALLY, THESE PATIENTS ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE HYPOTENSION IS VERY COMMON AND IS TREATED WITH STANDARD THERAPIES, INCLUDING VASOACTIVE DRUGS. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IN SOME CASES, THESE STANDARD MANEUVERS ARE NOT ADEQUATE, AND INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY IS REQUIRED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. AS A PRECAUTION, THE THV TRAINING MANUALS INSTRUCT THE OPERATOR TO 1) MINIMIZE THE NUMBER AND DURATION OF RAPID BURST PACING EPISODES, AND 2) ALLOW SUFFICIENT HEMODYNAMIC RECOVERY BEFORE INITIATING ANOTHER EPISODE OF RAPID PACING. IN THIS CASE, THE CAUSE OF THE REPORTED HYPOTENSION APPEARS TO BE THE SEVERE AI CAUSED BY THE BALLOON VALVULOPLASTY. PATIENT FACTORS WHICH MAY HAVE CONTRIBUTED TO THE HYPOTENSION INCLUDE EXTENSIVE CARDIOVASCULAR AND STRUCTURAL HEART DISEASE; PROCEDURAL FACTORS MAY HAVE INCLUDED ANESTHESIA, MEDICATIONS, AND RAPID VENTRICULAR PACING. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE FACILITY: THE PATIENT WAS SYMPTOMATICALLY IMPROVING AND GRADUALLY GAINING STRENGTH AND STAMINA. HIS PROSTHETIC VALVE APPEARS TO BE FUNCTIONING WELL BY EXAMINATION. THIS CASE PRESENTED DIFFICULT CHALLENGES DUE TO THE PATIENT¿S MEDICAL HISTORY, AND AS THE PATIENT WAS STILL ¿QUITE DECONDITIONED¿. IT WAS RECOMMENDED THAT THE PATIENT BE DISCHARGED TO OUTPATIENT CARDIAC REHABILITATION. PER THE 30 DAY POST TAVR ECHO REPORT THE BIOPROSTHETIC VALVE APPEARS WELL SEATED. THE PROSTHETIC LEAFLETS APPEAR THIN AND NORMALLY MOBILE. THE PEAK TRANS AV GRADIENT IS 22MMHG. THERE IS TRACE VALVULAR AORTIC INSUFFICIENCY. THERE IS EVIDENCE OF A TRACE TO MILD POSTERIOR PARAVALVULAR LEAK. THERE ARE IRREGULAR ECHOES ALONG THE AORTIC WALL CONSISTENT WITH ATHEROMA. THERE IS NO EVIDENCE OF PERICARDIAL EFFUSION, OR LV THROMBUS.

    Description of Event or Problem · 1

    AS REPORTED TO THE FIELD CLINICAL SPECIALIST, DURING A TRANSAPICAL PROCEDURE THE PATIENT¿S BLOOD PRESSURE BECAME UNSTABLE AFTER BALLOON AORTIC VALVULOPLASTY (BAV) WITH THE ASCENDRA BAVCATHETER AND SEVERE AORTIC INSUFFICIENCY WAS SEEN ON TRANSESOPHOGEAL ECHOCARDIOGRAPHY (TEE). CASE SUMMARY: DUE TO A LARGE AORTIC ANNULUS, THE CASE WAS PLANNED TO USE 2 SAPIEN VALVES: POSITION AND INFLATE THE FIRST, PERFORM POST-DILATATION TO FLARE THE VALVE AND PLACE A 2ND VALVE TO TREAT THE CENTRAL AORTIC INSUFFICIENCY (AI). THE PATIENT HAD NO ACCESS FOR BACKUP CARDIOPULMONARY SUPPORT (CPS). DUE TO POOR VISUALIZATION OF THE CORONARIES, A DIAGNOSTIC CATHETER WAS USED TO IMAGE TO LAD TO HELP DECIDE PROPER PLACEMENT OF THE PURSE STRING SUTURES IN THE APEX. THE SUTURES WERE PLACED AND THE SHEATH WAS INSERTED IN A NORMAL MANNER. AFTER THE BAV WAS DONE WITH A 20X3 ASCENDRA BAV CATHETER THE PATIENT¿S PRESSURE BECAME UNSTABLE AND SEVERE AI WAS SEEN ON TEE. THE 1ST 26MM VALVE WAS POSITIONED AND IMMEDIATELY IMPLANTED IN A 50:50 POSITION, THE SEVERE AI WAS STILL PRESENT AND THE PATIENT HAD NO BLOOD PRESSURE. IT WAS DECIDED TO IMMEDIATELY PLACE THE 2ND VALVE RATHER THAN CORRECT THE PRESSURE AND CHECK FOR THE AMOUNT OF PARAVALVULAR LEAK (PVL) OR CENTRAL AI. ONCE THE 2ND VALVE WAS INSERTED IN THE SHEATH IT WAS NOTED THAT WIRE POSITION WAS LOST, THE ANNULUS WAS RE-CROSSED WITH THE WIRE AND THE 2ND VALVE WAS PLACED IN SAME LOCATION INSIDE 1ST AND INFLATED. THE PATIENT REMAINED WITH NO PRESSURE UNDERNEATH FOR SEVERAL MINUTES. THE DELIVERY SYSTEM WAS REMOVED AND CPR WAS STARTED. A DOSE OF EPINEPHRINE WAS GIVEN THROUGH APICAL SHEATH AND CIRCULATED WITH CPR; THE PATIENT¿S PRESSURE RETURNED AND BECAME HYPERTENSIVE. THE SHEATH WAS REMOVED FROM THE APEX ONCE THE BLOOD PRESSURE NORMALIZED AND IT WAS CLOSED SUCCESSFULLY. TEE SHOWED A FINAL ASSESSMENT OF MILD PVL AND NO CENTRAL AI. THE PATIENT WAS SENT IN STABLE CONDITION TO THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342156 ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BAVC 59454675

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention