BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 8290371 · Received January 30, 2019

    Report

    Report Number
    2134265-2019-00265
    Event Type
    Death
    Date Received
    January 30, 2019
    Date of Event
    January 1, 2017
    Report Date
    January 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DREXEL T, HELMER G, GARCIA S, RAVEENDRAN G. MANAGEMENT OF LEFT MAIN CORONARY ARTERY OBSTRUCTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT UTILIZING A PERISCOPE APPROACH. CATHETER CARDIOVASC LNTERV. 2018; 92: 1444-1448. HTTPS:/ / DOI.ORG/10.1002/ CCD.27317. DATE OF EVENT: ESTIMATED AS THE FIRST DAY OF THE YEAR OF THE ARTICLE WAS PUBLISHED. COMBINATION PRODUCT: DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    (B)(6) REGISTRY. IT WAS REPORTED VIA LITERATURE THAT THROMBOSIS, CEREBRAL VASCULAR ACCIDENT AND DEATH OCCURRED. THE PATIENT UNDERWENT A TRANSFEMORAL TRANSAORTIC VALVE REPLACEMENT (TAVR) WITH MONITORED ANESTHESIA CARE IN A HYBRID OPERATING ROOM. VASCULAR ACCESS, BALLOON AORTIC VALVULOPLASTY WITH A 20-MM BALLOON AND VALE DELIVERY TO THE ASCENDING AORTA WERE COMPLETED WITHOUT DIFFICULTY. THE INITIAL POSITION OF THE VALVE RESULTED IN RIGHT CORONARY ARTERY OCCLUSION WITH RESULTANT BRADYCARDIA AND HYPOTENSION, SO THE VALVE WAS RECAPTURED WITH RESOLUTION OF BRADYCARDIA AND HYPOTENSION. THE VALVE WAS REPOSITIONED MORE VENTRICULAR AND DEPLOYED WITHOUT IMMEDIATE COMPLICATIONS. SUBSEQUENT TRANSTHORACIC ECHOCARDIOGRAPHY AND FLUOROSCOPIC IMAGING SHOWED NO PARAVALVULAR REGURGITATION AND A PATENT LEFT MAIN. PATIENT DID NOT AROUSE AS EXPECTED, BUT REMAINED HEMODYNAMICALLY STABLE SO WAS TRANSFERRED THE POSTANESTHESIA CARE UNIT (PACU) FOR FURTHER CARE. SHORTLY AFTER ARRIVING TO THE PACU PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE AND ULTIMATELY REQUIRED INITIATION OF ADVANCED CARDIAC LIFE SUPPORT (ACLS) MEASURES INCLUDING MANUAL CARDIOPULMONARY RESUSCITATION (CPR). HER RHYTHM DETERIORATED INTO VENTRICULAR FIBRILLATION REQUIRING MULTIPLE ELECTRICAL CARDIOVERSION TREATMENTS. THE ACLS TREATMENTS WERE UNSUCCESSFUL IN REVERSING HER CONDITION SO A MECHANICAL CPR DEVICE WAS PLACED AND SHE WAS BROUGHT EMERGENTLY TO THE CARDIAC CATHETERIZATION LABORATORY. SHE UNDERWENT EXTRACORPOREAL MEMBRANE OXYGENATION CANNULATION AND COMPLETE LIFE SUPPORT WAS INITIATED. AN ASCENDING AORTOGRAM IDENTIFIED AN ACUTE SUBTOTAL LEFT MAIN (LM) OCCLUSION WITH THE LOTUS VALVE STENT STRUCTURE EXTENDING ABOVE BOTH CORONARY OSTIA. A 3.5MM GUIDE CATHETER POSITIONED ON THE VALVE STENT STRUTS AT THE OF THE LM, BUT MULTIPLE ATTEMPTS TO PASS A WIRE BEYOND THE STENT STRUTS WERE UNSUCCESSFUL SO THIS APPROACH WAS ABANDONED. A GUIDE CATHETER WAS POSITIONED AT THE SUPERIOR RIM OF THE LOTUS VALVE ABOVE THE LEFT CORONARY ARTERY. A NON BOSTON SCIENTIFIC (BSC) GUIDE WIRE WAS ADVANCED BETWEEN THE LOTUS VALVE AND AORTA WALL AND THEN INTO THE LEFT CORONARY ARTERY WITH FINAL POSITIONING IN THE LEFT CIRCUMFLEX ARTERY. WITH GREAT DIFFICULTY, A 2.5 X 20 MM BALLOON WAS POSITIONED IN THE LM AND THE LESION, AND THEN THE PATH BETWEEN THE VALVE AND AORTA WERE TREATED WITH BALLOON ANGIOPLASTY. A STENT COULD NOT BE PASSED ACROSS THE VALVE TO GET INTO THE LM, SO THE PATHWAY BETWEEN THE PROSTHETIC VALVE AND AORTIC WALL AS WELL AS THE LM LESION WERE FURTHER TREATED WITH 3.5 X 12MM, 3.5 X20 MM, AND 4.0 X 20 MM BALLOONS. AFTER MANY ATTEMPTS, A SYNERGY DRUG ELUTING STENT WAS DEPLOYED EXTENDING FROM THE AORTA JUST SUPERIOR TO THE PROSTHETIC VALVE TO THE DISTAL LM TRAVERSING BETWEEN THE VALVE AND AORTIC WALL. THE INITIAL STENT WAS SUCCESSFUL IN TREATING THE LM LESION WITH RESTORATION OF TIMI 3 FLOW. ALTHOUGH THE LM LESION WAS TREATED, THE STENT SEGMENT BETWEEN THE AORTIC WALL AND PROSTHETIC VALVE BECAME CRUSHED FROM THE RECOIL AND RADIAL STRENGTH OF THE LOTUS VALVE. A TOTAL OF FIVE CONCENTRICALLY-POSITIONED STENTS, INCLUDING SYNERGY 4.0 X 24 MM, SYNERGY 40 X 16 MM, SYNERGY 4.0 X 12 MM, NON-BSC 4.0 X 12 MM AND NON-BSC 3.5 X 15 MM, WERE PLACED WITH GREAT DIFFICULTY. THE STENTS WERE IMPLANTED CONCENTRICALLY WITH THE TWO BARE METAL STENTS FINALLY ACHIEVING A STRONG ENOUGH SCAFFOLD TO RESIST THE PROSTHETIC VALVE'S RADIAL EXPANSION. THE INITIAL THREE SYNERGY STENTS WERE THE ONLY STENTS THAT COULD PENETRATE THE CRUSHED STENTED SEGMENT, OTHERWISE STENTS WITH GREATER RADIAL STRENGTH WOULD HAVE BEEN IMPLANTED INITIALLY. THE STENTED SEGMENT WAS POSTDILATED WITH A 4.5 X 12 MM NONCOMPLIANT BALLOON. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF PERFORATION OR DISSECTION WITH RESIDUAL STENOSIS OF 25% AND TIMI 3 FLOW. LASTLY, A COOLING CATHETER WAS INSERTED FOR THERAPEUTIC HYPOTHERMIA TREATMENT. PATIENT WAS TRANSFERRED FROM THE CARDIAC CATHETERIZATION LABORATORY TO RADIOLOGY FOR COMPUTED TOMOGRAPHY (CT) OF THE HEAD TO EVALUATE PATENTS INABILITY TO AROUSE FOLLOWING COMPLETION OF THE TAVR PROCEDURE. THE CT SHOWED ACUTE BILATERAL MIDDLE CEREBRAL ARTERY AND POSTERIOR CEREBRAL ARTERY INFARCTS ASSOCIATED WITH DIFFUSE CEREBRAL EDEMA AND NEAR COMPLETE EFFACEMENT OF THE BASAL CISTERNS. A FAMILY CONFERENCE WAS HELD THE FOLLOWING DAY AND DECISION WAS MADE TO WITHDRAW LIFE SUPPORT GIVEN HER POOR NEUROLOGIC AND CARDIAC PROGNOSES. AN AUTOPSY SHOWED THE MULTIPLE STENTS IN THE PERISCOPE CONFIGURATION AS WELL AS THE LEFT ANTERIOR DESCENDING AND PROXIMAL LEFT CIRCUMFLEX STENOSES. THE LM HAD CALCIFIC NODULES BETWEEN THE STENTS AND ENDOTHELIAL WALL THAT RAISED SUSPICION FOR AN EMBOLIC EVENT, BUT COULD NOT BE CERTAIN THAT THE CALCIUM WAS NOT RELATED TO CHRONIC CALCIFIC CORONARY ARTERY DISEASE. IDENTIFICATION OF ACUTE THROMBUS WAS COMPLICATED BY THE STENT IMPLANTATION AND COULD NOT BE ADEQUATELY ASSESSED. ALTHOUGH SOMEWHAT DIFFICULT TO ASCERTAIN, THE NATIVE VALVE LEAFLETS DID NOT APPEAR TO BE OBSTRUCTING THE CORONARY OSTIUM AND WERE RESTING BELOW WITHIN THE SUPERIOR OPHTHALMIC VEIN (SOV). THE PROSTHETIC VALVE DID NOT APPEAR TO BE DEFORMED BY THE MECHANICAL CHEST COMPRESSIONS OR THE PERISCOPE STENTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84324 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death