BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 3310093 · Received August 27, 2013

    Report

    Report Number
    9616099-2013-00547
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    February 5, 1998
    Report Date
    August 5, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HIGH-GRADE STENOSIS. BALLOON DILATION WAS FOLLOWED BY DEPLOYMENT OF A BALLOON-EXPANDABLE PALMAZ P154 STENT (CORDIS, A JOHNSON AND JOHNSON CO., (B)(4) USA) AT THE SITE OF THE PREOCCLUSIVE OSTIAL RENAL ARTERY LESION. THE STENT WAS EXPANDED TO A DIAMETER OF 6 MM, WHICH ERADICATED THE 104-MMHG PRETREATMENT TRANSSTENOTIC PRESSURE GRADIENT. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. DURING THE NEXT 24 HOURS, THE PATIENT HAD A 6-L DIURESIS AND WAS WEANED FROM MECHANICAL VENTILATION. HER SERUM CREATININE HAD FALLEN TO 2.0 MG/DL BY THE TIME OF DISCHARGE; 6 WEEKS AFTER THE INTERVENTIONAL PROCEDURE, IT WAS FURTHER REDUCED TO 1.5 MG/DL. HER CARDIOPULMONARY STATUS LIKEWISE IMPROVED, AND AFTER A NORMAL DOBUTAMINE STRESS ECHOCARDIOGRAM, SHE UNDERWENT SURGICAL REPAIR OF HER TAA. DURING THIS PROCEDURE, THE STENT WAS EASILY VISUALIZED WITHIN THE OSTIUM OF THE RIGHT RENAL ARTERY. SINCE IT WAS FIRMLY INCORPORATED, WIDELY PATENT, AND POTENTIALLY DIFFICULT TO REMOVE, IT WAS LEFT UNDISTURBED, AND NO ATTEMPT WAS MADE TO PERFORM AN ENDARTERECTOMY OF THE RENAL ARTERY. TWO WEEKS AFTER ANEURYSM REPAIR, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A CREATININE OF 1.2 MG/DL AND NORMAL BLOOD PRESSURE ON TWO ANTIHYPERTENSIVE MEDICATIONS. TEN MONTHS AFTER RENAL ARTERY STENTING, RECURRENT RENAL ARTERY STENOSIS WAS DISCOVERED DURING ROUTINE SURVEILLANCE WITH DUPLEX ULTRASONOGRAPHY. ARTERIOGRAPHY CONFIRMED APPROXIMATELY 50% RESTENOSIS WITHIN THE STENTED SEGMENT WITH A TRANS-STENOTIC GRADIENT OF 10 MMHG. THE STENOSIS WAS DILATED WITH A 7-MM BALLOON WITH GOOD ARTERIOGRAPHIC AND HEMODYNAMIC RESULTS. AT HER MOST RECENT EVALUATION 21 MONTHS FOLLOWING REDILATION (31 MONTHS AFTER STENT PLACEMENT), THE PATIENT HAS REMAINED NORMOTENSIVE ON A SINGLE MEDICATION. THERE HAS BEEN NO FURTHER EVIDENCE OF RENAL ARTERY STENOSIS BY DUPLEX ULTRASONOGRAPHY. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: SULLIVAN ET AL STENTING OF THE RENAL ARTERY TO IMPROVE RENAL FUNCTION PRIOR TO THORACOABDOMINAL ANEURYSM REPAIR; J ENDOVASC SURG. 1998 FEB;5(1):56-9, AS NOTED IN THE PUBLICATION SULLIVAN ET AL STENTING OF THE RENAL ARTERY TO IMPROVE RENAL FUNCTION PRIOR TO THORACOABDOMINAL ANEURYSM REPAIR; J ENDOVASC SURG. 1998 FEB;5(1):56-9, REPORT RESTENOSIS (50% DIAMETER REDUCTION) IN THE RENAL ARTERY WAS FOUND 10 MONTHS AFTER STENTING WITH A PALMAZ STENT AND TREATED WITH REPEAT DILATION. THE (B)(6) FEMALE PATIENT WAS INITIALLY ADMITTED TO THE SURGICAL INTENSIVE CARE UNIT BECAUSE OF UNCONTROLLED HYPERTENSION (240/130 MMHG) DESPITE FOUR ANTIHYPERTENSIVE MEDICATIONS, WORSENING CHF, AND PROGRESSIVE RENAL INSUFFICIENCY (SERUM CREATININE 3.8 MG/DL). A COMPUTERIZED TOMOGRAPHIC SCAN HAD PREVIOUSLY IDENTIFIED A LARGE (6 CM) CRAWFORD TYPE IV TAA EXTENDING FROM THE DIAPHRAGM TO THE AORTIC BIFURCATION, AS WELL AS A SMALL (4 CM) NONFUNCTIONING LEFT KIDNEY. DUPLEX ULTRASONOGRAPHY OF THE RENAL ARTERIES REVEALED HIGH-GRADE (80%) STENOSIS OF THE RIGHT RENAL ARTERY, WHICH WAS CONFIRMED BY SUBSEQUENT DIAGNOSTIC ARTERIOGRAPHY. WITH AGGRESSIVE BLOOD PRESSURE CONTROL USING INTRAVENOUS SODIUM NITROPRUSSIDE, THE PATIENT BECAME OLIGURIC, WITH AN INCREASE IN THE CREATININE TO 5.3 MG/DL. HER CHF WORSENED, AND SHE REQUIRED ENDOTRACHEAL INTUBATION AND MECHANICAL VENTILATION. SEVERAL TREATMENT OPTIONS WERE CONSIDERED: OPTIMIZATION OF HEMODYNAMICS AND URGENT SURGICAL REPAIR OF THE TAA, WITH SIMULTANEOUS ENDARTERECTOMY OF THE RIGHT RENAL ARTERY; RENAL ARTERY ANGIOPLASTY (WITHOUT STENTING) FOR TEMPORARY STABILIZATION OR IMPROVEMENT OF RENAL FUNCTION, FOLLOWED BY TAA REPAIR AND RENAL ARTERY ENDARTERECTOMY; AND RENAL ARTERY ANGIOPLASTY AND STENTING, WITH INDEFINITE POSTPONEMENT OF THE TAA PROCEDURE UNTIL THE GENERAL MEDICAL CONDITION HAD IMPROVED. BECAUSE OF THE RAPID DETERIORATION OF RENAL AND PULMONARY STATUS, THE THIRD OPTION WAS CHOSEN FOR THIS PARTICULAR PATIENT. INFORMED CONSENT WAS OBTAINED FOR THE INVESTIGATIONAL USE OF STENTS IN THE RENAL ARTERY. THROUGH A PERCUTANEOUS RIGHT FEMORAL APPROACH, SELECTIVE RIGHT RENAL ARTERIOGRAPHY CONFIRMED THE HIGH-GRADE STENOSIS. BALLOON DILATION WAS FOLLOWED BY DEPLOYMENT OF A BALLOON-EXPANDABLE PALMAZ P154 STENT (CORDIS, A JOHNSON AND JOHNSON CO.,(B)(4) USA) AT THE SITE OF THE PREOCCLUSIVE OSTIAL RENAL ARTERY LESION. THE STENT WAS EXPANDED TO A DIAMETER OF 6 MM, WHICH ERADICATED THE 104-MMHG PRETREATMENT TRANSSTENOTIC PRESSURE GRADIENT. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. DURING THE NEXT 24 HOURS, THE PATIENT HAD A 6-L DIURESIS AND WAS WEANED FROM MECHANICAL VENTILATION. HER SERUM CREATININE HAD FALLEN TO 2.0 MG/DL BY THE TIME OF DISCHARGE; 6 WEEKS AFTER THE INTERVENTIONAL PROCEDURE, IT WAS FURTHER REDUCED TO 1.5 MG/DL. HER CARDIOPULMONARY STATUS LIKEWISE IMPROVED, AND AFTER A NORMAL DOBUTAMINE STRESS ECHOCARDIOGRAM, SHE UNDERWENT SURGICAL REPAIR OF HER TAA. DURING THIS PROCEDURE, THE STENT WAS EASILY VISUALIZED WITHIN THE OSTIUM OF THE RIGHT RENAL ARTERY. SINCE IT WAS FIRMLY INCORPORATED, WIDELY PATENT, AND POTENTIALLY DIFFICULT TO REMOVE, IT WAS LEFT UNDISTURBED, AND NO ATTEMPT WAS MADE TO PERFORM AN ENDARTERECTOMY OF THE RENAL ARTERY. TWO WEEKS AFTER ANEURYSM REPAIR, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A CREATININE OF 1.2 MG/DL AND NORMAL BLOOD PRESSURE ON TWO ANTIHYPERTENSIVE MEDICATIONS. TEN MONTHS AFTER RENAL ARTERY STENTING, RECURRENT RENAL ARTERY STENOSIS WAS DISCOVERED DURING ROUTINE SURVEILLANCE WITH DUPLEX ULTRASONOGRAPHY. ARTERIOGRAPHY CONFIRMED APPROXIMATELY 50% RESTENOSIS WITHIN THE STENTED SEGMENT WITH A TRANS-STENOTIC GRADIENT OF 10 MMHG. THE STENOSIS WAS DILATED WITH A 7-MM BALLOON WITH GOOD ARTERIOGRAPHIC AND HEMODYNAMIC RESULTS. AT HER MOST RECENT EVALUATION 21 MONTHS FOLLOWING REDILATION (31 MONTHS AFTER STENT PLACEMENT), THE PATIENT HAS REMAINED NORMOTENSIVE ON A SINGLE MEDICATION. THERE HAS BEEN NO FURTHER EVIDENCE OF RENAL ARTERY STENOSIS BY DUPLEX ULTRASONOGRAPHY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF PERIPHERAL ARTERY DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. PLEASE NOTE THAT THE REPORTED DEVICE SHOULD BE A PALMAZ P314, HOWEVER AS THIS IS NOT A VALID CATALOG NUMBER AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    SULLIVAN ET AL STENTING OF THE RENAL ARTERY TO IMPROVE RENAL FUNCTION PRIOR TO THORACOABDOMINAL ANEURYSM REPAIR; J ENDOVASC SURG. 1998 FEB;5(1):56-9, REPORT RESTENOSIS (50% DIAMETER REDUCTION) IN THE RENAL ARTERY WAS FOUND 10 MONTHS AFTER STENTING WITH A PALMAZ STENT AND TREATED WITH REPEAT DILATION. THE PATIENT WAS INITIALLY ADMITTED TO THE SURGICAL INTENSIVE CARE UNIT BECAUSE OF UNCONTROLLED HYPERTENSION (240/130 MMHG) DESPITE FOUR ANTIHYPERTENSIVE MEDICATIONS, WORSENING CHF, AND PROGRESSIVE RENAL INSUFFICIENCY (SERUM CREATININE 3.8 MG/DL). A COMPUTERIZED TOMOGRAPHIC SCAN HAD PREVIOUSLY IDENTIFIED A LARGE (6 CM) CRAWFORD TYPE IV TAA EXTENDING FROM THE DIAPHRAGM TO THE AORTIC BIFURCATION, AS WELL AS A SMALL (4 CM) NONFUNCTIONING LEFT KIDNEY. DUPLEX ULTRASONOGRAPHY OF THE RENAL ARTERIES REVEALED HIGH-GRADE (80%) STENOSIS OF THE RIGHT RENAL ARTERY, WHICH WAS CONFIRMED BY SUBSEQUENT DIAGNOSTIC ARTERIOGRAPHY. WITH AGGRESSIVE BLOOD PRESSURE CONTROL USING INTRAVENOUS SODIUM NITROPRUSSIDE, THE PATIENT BECAME OLIGURIC, WITH AN INCREASE IN THE CREATININE TO 5.3 MG/DL. HER CHF WORSENED, AND SHE REQUIRED ENDOTRACHEAL INTUBATION AND MECHANICAL VENTILATION. SEVERAL TREATMENT OPTIONS WERE CONSIDERED: OPTIMIZATION OF HEMODYNAMICS AND URGENT SURGICAL REPAIR OF THE TAA, WITH SIMULTANEOUS ENDARTERECTOMY OF THE RIGHT RENAL ARTERY; RENAL ARTERY ANGIOPLASTY (WITHOUT STENTING) FOR TEMPORARY STABILIZATION OR IMPROVEMENT OF RENAL FUNCTION, FOLLOWED BY TAA REPAIR AND RENAL ARTERY ENDARTERECTOMY; AND RENAL ARTERY ANGIOPLASTY AND STENTING, WITH INDEFINITE POSTPONEMENT OF THE TAA PROCEDURE UNTIL THE GENERAL MEDICAL CONDITION HAD IMPROVED. BECAUSE OF THE RAPID DETERIORATION OF RENAL AND PULMONARY STATUS, THE THIRD OPTION WAS CHOSEN FOR THIS PARTICULAR PATIENT. INFORMED CONSENT WAS OBTAINED FOR THE INVESTIGATIONAL USE OF STENTS IN THE RENAL ARTERY. THROUGH A PERCUTANEOUS RIGHT FEMORAL APPROACH, SELECTIVE RIGHT RENAL ARTERIOGRAPHY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420455 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R