BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ BLUE .018 (T_HEPATIC) PERIPHERAL

    MDR report key: 1031094 · Received April 17, 2008

    Report

    Report Number
    9610978-2008-00099
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    March 21, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K040413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REVIEW OF AN ARTICLE WRITTEN BY SCOTT W. ROBERTSON, PHD, TITLED "RIGHT RENAL ARTERY IN VIVO STENT FRACTURE". APPROXIMATELY ONE YEAR AFTER THE INTERVENTION TREATMENT, THE PATIENT EXPERIENCE CHEST DISCOMFORT. THE HYPERTENSION REGIMEN HAD INCREASED WITH UP-TITRATION OF THE LISINOPRIL TO 40MG, THE ADDITION OF FUROSEMIDE 40MG, AMLIDIPINE 10MG, AND CARVEDILOL. LEFT HEART CATHETERIZATION ILLUSTRATED STABLE AND SEVERE NATIVE AND GRAFT CORONARY ARTERY DISEASE, PRESERVED LEFT VENTRICULAR SYSTOLIC FUNCTION, AND SEVERE IN-STENT RESTENOSIS OF THE (RRA) RIGHT RENAL ARTERY ASSOCIATED WITH TYPE I STENT FRACTURE. SUBINTIMAL STRUT FRACTURE OCCURRED JUST DISTAL TO THE RENAL OSTIUM IN THE SECOND RING OF THE STENT AND RESULTED IN 90% RE-STENOSIS OF THE RRA. THE RE-STENOSED ARTERY WAS TREATED WITH PTA BY USING A 6X20MM SAVVY BALLOON INFLATED TO 10 ATMOSPHERES THAT REDUCED THE RESIDUAL STENOSIS TO 30%. ADDITIONAL PTA WITH A 7X20MM AVIATOR PLUS BALLOON WAS CONDUCTED AND INFLATED TO 12 ATMOSPHERES THAT FURTHER REDUCED THE STENOSIS 10%. A PALMAZ BLUE 7X15MM STENT WAS DEPLOYED AT 12 ATMOSPHERES OVERLAPPING THE ORIGINAL STENT. POST-DILATION WITH STENT DELIVERY SYSTEM WAS CONDUCTED AT 14 ATMOSPHERES. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLAINTS OR ADVERSE EVENT. THE PREVIOUSLY UNYIELDING INFERIOR CALCIUM DID YIELD DURING THE SECOND PROCEDURE SUGGESTING THAT ITS PRESENCE WAS THE CAUSE FOR THE ORIGINAL FLANK PAIN, AND THE SUBSEQUENT POST-STENT REMODELING OR REDUCTION OF THE LESION RESULTED IN PAIN ELIMINATION. THE PATIENT WAS EVALUATED AT ONE WEEK AFTER THE SECONDARY STENT PLACEMENT AND PRESENTED NO EVIDENCE OF COMPLICATIONS. AT FOUR MONTHS, THE PATIENT IS NORMOTENSIVE ON CARVEDILOL, FUROSEMIDE, LISINOPRIL, AND AMLODIPINE. ADDITIONALLY THE JOURNAL ARTICLE DISCUSSION INDICATED THAT THIS PATIENT'S NATIVE RRA DEFLECTS CAUDALLY 45 DEGREES FOR SEVERAL MILLIMETERS DISTAL TO THE OSTIUM BEFORE RETURNING TO A MORE LATERAL PATH. AFTER STENT PLACEMENT IN THE OSTIAL RENAL ARTERY WITH ITS PROXIMAL END RESIDUAL ARTERY WITH ITS PROXIMAL END RESIDING JUST IN THE ABDOMINAL AORTA, THE EFFECTIVE PATH OF THAT ARTERY HAD LESS ANGULATION AS THE STENT ACTED AS BALLAST, FORCING THE ARTERY OSTIUM TO A LINEAR PATH FROM THE OSTIUM INTO THE DISTAL RENAL ARTERY. WITHIN A YEAR OF THE INITIAL PROCEDURE, HOWEVER, THE ARTERY HAD RETURNED TO ITS NATIVE ANGLED CONFORMATION. THEY SUMMARIZED THAT THE BIOMECHANICAL FORCES INVOLVED IN THIS PROCESS IMPOSED LOCALLY ELEVATED STRESSES AND/OR STRAINS ON THE PROXIMAL END OF THE STENT NEAR THE OSTIUM. MOREOVER, THEY OPINE THAT THE DISEASED OSTIUM WAS HEAVILY CALCIFIED AND, THEREFORE, FAR LESS COMPLAINT THAN NON-DISEASED ANATOMY, THEREBY IMPARTING GREATER FORCES IN THIS PROXIMAL REGION OF THE STENT DURING ANATOMIC MOTION OF THE VESSEL. INDEED THE ANGIOGRAM OBTAINED ONE YEAR LATER REVEALED AN ACCOMMODATION OF THE VESSEL BACK TO ITS ORIGINAL CAUDAL ANGULATION, CONCOMITANT WITH A STENT STRUT FRACTURE AT THE EFFECTIVE HINGE POINT NEAR THE CALCIFIED OSTIUM. THIS PATIENT WAS ADMITTED FOR THE INDEX PROCEDURE WITH THE MEDICAL HISTORY OF HYPERLIPIDEMIA AND UNCONTROLLED HYPERTENSION, PRESERVE LEFT VENTRICULAR SYSTOLIC FUNCTION, SEVERE NATIVE AND GRAFT CORONARY ARTERY DISEASE, MODERATELY SEVERE PULMONARY EDEMA, CHEST PAIN, AND RENAL INSUFFICIENCY. THE PATIENT WAS RECEIVING 50MG OF ATENOLOL, 40MG OF LISINOPRIL, 25MG OF HYDROCHLOROTHIAZIDE, 10MG OF AMLODIPINE, 20MG OF NIFEDIPINE, 4MG OF DOXAZOSIN, AND 40MG OF FUROSEMIDE. LEFT HEART CATHETERIZATION CONFIRMED STABLE CORONARY ARTERY DISEASE AND LEFT VENTRICULAR SYSTOLIC FUNCTION. RENAL DUPLEX ULTRASONOGRAPHY SUGGESTED MORE THAN 60% STENOSIS OF THE (RRA) RIGHT RENAL ARTERY ASSOCIATED WITH A 1 CM DISCREPANCY IN RENAL ARTERY LENGTH (RIGHT RENAL 11.1 CM; LEFT RENAL 12.1 CM). DIAGNOSTIC RENAL ANGIOGRAPHY SHOWED A SEVERELY CALCIFIED OSTIAL RRA STENOSIS WITH AN ASSOCIATED 20MMHG PRESSURE GRADIENT AFTER ENGAGEMENT WITH A 4FRENCH INFERIOR MAMMARY ARTERY DIAGNOSTIC CATHETER. ANGIOPLASTY AND STENT PLACEMENT WAS PERFORMED WITH SERIAL (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. A MEDTRONIC 3X20MM SPRINTER BALLOON WAS INFLATED TO 10 ATMOSPHERES, FOLLOWED BY A SECOND 4 X 20MM SPRINTER BALLOON INFLATED TO 12 ATMOSPHERES WHICH RUPTURED AFTER 24 SECONDS, AND FINALLY A BOSTON SCIENTIFIC QUANTUM MAVERICK 4.5 X 15MM BALLOON INFLATED TO 10 ATMOSPHERES. DURING EACH ANGIOPLASTY, THE BALLOONS FULLY INFLATED WITHOUT D0G-BONING. THIS MULTI-ANGIOPLASTY APPROACH WAS USED BECAUSE THE SEVERE STENOSIS AND INFERIOR ANGULATION PROHIBITED TRADITIONAL PERIPHERAL BALLOONS FROM TRAVERSING THE LESION. AFTER PTA, THE VESSEL WAS TREATED WITH A 7X18MM PALMAZ BLUE STENT MOUNTED ON A SLALOM BALLOON THAT WAS DEPLOYED AT 5 ATMOSPHERES. THE STENT WAS POST DILATED WITH THE SAME BALLOON AT 8 ATMOSPHERES FOR 30 SECONDS. SECONDARY POST-DILATION WAS PERFORMED IN THE OSTIAL RRA BY USING AN 8X20MM SLALOM BALLOON THAT WAS INFLATED TO 6 ATMOSPHERES, DURING WHICH THE PATIENT COMPLAINT FLANK PAIN. THE INTERVENTION RESULTED IN A 60% LUMEN DIAMETER OPENING OF THE TARGET LESION. THE SUBOPTIMAL 40% RESIDUAL STENOSIS, AND PERHAPS THE FLANK PAIN, WAS DUE TO THE UNYIELDING HIGHLY CALCIFIED, INFERIOR RENAL PLAQUE. THE PATIENT TOLERATED THE PROCEDURE WELL, AND THE HYPERTENSION REGIMEN WAS REDUCED TO CARVEDILOL 25MG TWICE A DAY AND LISINOPRIL 10MG DAILY. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS UNAVAILABLE FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO VESSEL CHARACTERISTICS.

    Description of Event or Problem · 1

    THE J VASCULAR INTERVENTIONAL RADIOLOGY AUTHORS DESCRIBE AN INCIDENT OF A TYPE I SINGLE STRUT FRACTURE IN A RIGHT RENAL ARTERY (RRA) STENT RESULTING IN A ~90% STENOSIS. FRACTURE WAS OBSERVED JUST DISTAL TO THE OSTIUM APPROXIMATELY 1 YEAR AFTER IMPLANTATION IN A MAN WITH A HISTORY OF SYSTEMIC CARDIOVASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BLUE .018 (T_HEPATIC) PERIPHERAL ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 6X20MM SAVVY BALLOON| 7X20MM AVIATOR PLUS BALLOON