BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT LARGE ILIACR 30MM

    MDR report key: 3115249 · Received May 16, 2013

    Report

    Report Number
    1016427-2013-00063
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    August 1, 2004
    Report Date
    April 19, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K911581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACROSS THE COARCTATION SITE. THE STENT WAS CRIMPED ON A BALLOON DILATION CATHETER AND ADVANCED WITHIN THE SHEATH TO THE COARCTATION SITE. THE MAJORITY OF THE STENTS WERE PALMAZ (P188, P308, P4010; (B)(4)). ONE INTRATHERAPEUTICS DOUBLE-STRUT (IT-DS 26; (B)(4)) STENT WAS USED. THE BALLOON SIZE WAS CHOSEN TO EQUAL TO OR NOT EXCEED THE DIAMETER OF THE NARROWEST PROXIMAL AORTIC MEASUREMENT BY MORE THAN 3 MM. THE MAJORITY OF BALLOON CATHETERS USED WERE Z-MED ((B)(4)). ADDITIONALLY, BIB ((B)(4)), POWERFLEX ((B)(4)), XXL AND PEMT ((B)(4)) BALLOONS WERE UTILIZED. ONCE THE MOUNTED SHEATH WAS DELIVERED TO THE COARCTATION SITE, THE SHEATH WAS DRAWN BACK TO EXPOSE THE STENT AND A HAND INJECTION OF CONTRAST THROUGH THE SHEATH WAS PERFORMED TO VERIFY THE STENT POSITION. THE STENT POSITION WAS ADJUSTED AS NECESSARY, WITH REPEATED ANGIOGRAMS, UNTIL THE DESIRED POSITION WAS ACHIEVED. THE BALLOON WAS INFLATED TO EXPAND THE STENT FULLY OR UNTIL THE RECOMMENDED PRESSURE WAS ACHIEVED. IF NEEDED, FURTHER INFLATION OF THE PROXIMAL AND/OR DISTAL ENDS OF THE STENT WAS PERFORMED; USUALLY THIS WAS PERFORMED WITH A LARGER DIAMETER BALLOON. ALL PATIENTS NOT ALREADY ON ANTICOAGULATION THERAPY WERE STARTED ON LOW-DOSE ASPIRIN (3-5 MG/KG). THE DURATION OF ASPIRIN THERAPY WAS FOR AT LEAST 6 MONTHS. THE PEAK-TO-PEAK SYSTOLIC GRADIENT ACROSS THE COARCTATION MEASURED DURING THE CATHETERIZATION DECREASED IN ALL PATIENTS. THE DECREASE IN THE MEAN PEAK-TO-PEAK SYSTOLIC GRADIENT, FROM 31 TO 1.7 MM HG, WAS STATISTICALLY SIGNIFICANT. THE NARROWEST DIAMETER AT THE COARCTATION SITE INCREASED IN ALL PATIENTS. THE MEAN DIAMETER INCREASE, FROM 8.1 TO 13.5 MM, WAS STATISTICALLY SIGNIFICANT. PLEASE NOTE THAT THIS EVENT WAS FOUND IN A LITERATURE REVIEW. THE CITATION IS AS FOLLOWS: JOHNSTON ET AL ENDOVASCULAR STENTS FOR TREATMENT OF COARCTATION OF THE AORTA: ACUTE RESULTS AND FOLLOW-UP EXPERIENCE; CATHETER CARDIOVASC INTERVENTIONS. 2004; 62(4):499-505. THE LOT NUMBER IS NOT CURRENTLY AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF 3 DEVICES ASSOCIATED WITH EVENTS NOTED IN THE ARTICLE THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS THIS IS ONE OF 3 DEVICES ASSOCIATED WITH EVENTS NOTED IN THE ARTICLE THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2013-00298, 1016427-2013-00063 AND 1016427-2013-00064.

    Additional Manufacturer Narrative · 1

    THE ARTICLE, JOHNSTON ET AL ENDOVASCULAR STENTS FOR TREATMENT OF COARCTATION OF THE AORTA: ACUTE RESULTS AND FOLLOW-UP EXPERIENCE; CATHETER CARDIOVASC INTERVENTIONS. 2004; 62(4):499-505 REPORTED COMPLICATIONS INCLUDING ONE STENT MIGRATION, ONE AORTIC DISSECTION AND ONE STENT FRACTURE OF PALMAZ STENTS USED IN THE STUDY. ONE CASE WAS COMPLICATED BY SUBOPTIMAL STENT PLACEMENT RESULTING IN ELECTIVE SURGICAL STENT REMOVAL. THIS PATIENT WITH NATIVE COARCTATION HAD A DISCRETE STENOSIS BUT WITH LARGE PRE- AND POST-AORTIC DIAMETERS. THE STENT POSITION COULD NOT BE MAINTAINED DURING INFLATION TO PREVENT DISTAL MIGRATION OF THE BALLOON AND STENT. THE PREVIOUSLY DIAGNOSED COARCTATION WAS REPAIRED SURGICALLY. THE ARTICLE NOTED, ¿IN RETROSPECT, IT IS POSSIBLE THAT THE USE OF A LONGER BALLOON AND STENT WOULD HAVE REDUCED THE PROBABILITY OF STENT MIGRATION.¿ ANOTHER PATIENT DEVELOPED DISSECTION OF THE AORTA WITH A LARGE PERIAORTIC HEMATOMA 2 DAYS FOLLOWING THE PROCEDURE. SURGICAL REPAIR WAS PERFORMED IN THIS CASE AS WELL. AS REPORTED, ¿THE AORTIC DISSECTION IN THE SERIES WAS LIKELY RELATED TO THE DISTAL END OF THE STENT DISRUPTING THE INTEGRITY OF THE AORTIC WALL. THE COMBINATION OF STENT LOCATION AND OVER DILATION RESULTED IN THE DISTAL END OF THE STENT ENGAGING IN THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY. THE DISSECTION STARTED IN THIS LOCATION AND TRACKED INTO THE AORTIC ARCH AND CAROTID ARTERIES.¿ A THIRD PATIENT HAD A RESIDUAL POSTOPERATIVE TRANSVERSE ARCH OBSTRUCTION. THE STENT DIAMETER DECREASED DURING THE INTERVAL BETWEEN PROCEDURES. THIS WAS DUE TO A FRACTURE OF THE STENT THAT BECAME EVIDENT AT THE LAST CATHETERIZATION. FOR THE PATIENTS INCLUDED IN THIS STUDY, HEPARIN WAS GIVEN PRIOR TO THE LEFT HEART CATHETERIZATION AND THE ACTIVATED CLOTTING TIME WAS MONITORED WITH A GOAL OF GREATER THAN 200 SEC. THE INTERVENTION WAS PERFORMED VIA RETROGRADE APPROACH. HEMODYNAMIC DATA WAS OBTAINED AND ANGIOGRAPHIC MEASUREMENTS WERE PERFORMED. THE DIAMETER OF THE AORTA WAS MEASURED PROXIMAL AND DISTAL TO THE COARCTATION SITE IN ADDITION TO THE NARROWEST DIAMETER. A GUIDEWIRE WAS PLACED ACROSS THE SITE OF THE COARCTATION. ORIGINALLY, THE DISTAL TIP OF THE WIRE WAS POSITIONED IN EITHER THE ASCENDING AORTA OR THE LEFT VENTRICLE. IN LATER PROCEDURES, THE WIRE WAS POSITIONED IN THE LEFT CAROTID OR LEFT SUBCLAVIAN ARTERIES TO MAINTAIN A STRAIGHTER BALLOON STENT PROFILE, THEREBY REDUCING THE POTENTIAL FOR PUNCTURE OF THE BALLOON BY THE EDGE OF THE STENT. THIS GUIDEWIRE WAS USED TO POSITION AN 8 TO 12 FR SHEATH ACROSS THE COARCTATION SITE. THE STENT WAS CRIMPED ON A BALLOON DILATION CATHETER AND ADVANCED WITHIN THE SHEATH TO THE COARCTATION SITE. THE BALLOON SIZE WAS CHOSEN TO EQUAL TO OR NOT EXCEED THE DIAMETER OF THE NARROWEST PROXIMAL AORTIC MEASUREMENT BY MORE THAN 3 MM. ONCE THE MOUNTED SHEATH WAS DELIVERED TO THE COARCTATION SITE, THE SHEATH WAS DRAWN BACK TO EXPOSE THE STENT AND A HAND INJECTION OF CONTRAST THROUGH THE SHEATH WAS PERFORMED TO VERIFY THE STENT POSITION. THE STENT POSITION WAS ADJUSTED AS NECESSARY, WITH REPEATED ANGIOGRAMS, UNTIL THE DESIRED POSITION WAS ACHIEVED. THE BALLOON WAS INFLATED TO EXPAND THE STENT FULLY OR UNTIL THE RECOMMENDED PRESSURE WAS ACHIEVED. IF NEEDED, FURTHER INFLATION OF THE PROXIMAL AND/OR DISTAL ENDS OF THE STENT WAS PERFORMED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT LOT NUMBERS. THE REPORTS OF ¿INACCURATE PLACEMENT¿, ¿AORTIC DISSECTION¿ AND ¿STENT MIGRATION¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED. THE EXACT CAUSES OF THE EVENTS REPORTED COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE, THE REPORTED INACCURATE PLACEMENT OF A PALMAZ STENT MAY HAVE BEEN DUE TO THE STRUCTURE OF THE AORTA SURROUNDING THE COOARCTATION AND THE SIZE OF STENT CHOSEN TO COMPLETE TREATMENT. THE SECOND CASE, OVER DILATION MAY HAVE CONTRIBUTED TO THE REPORTED AORTIC DISSECTION AS NOTED IN THE ARTICLE. WITH THE LIMITED INFORMATION AVAILABLE IN REGARD TO THE STENT FRACTURE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 3 DEVICES ASSOCIATED WITH EVENTS NOTED IN THE ARTICLE THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS THIS IS ONE OF 3 DEVICES ASSOCIATED WITH EVENTS NOTED IN THE ARTICLE THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2013-00298, 1016427-2013-00063 AND 1016427-2013-00064.

    Description of Event or Problem · 1

    JOHNSTON ET AL ENDOVASCULAR STENTS FOR TREATMENT OF COARCTATION OF THE AORTA: ACUTE RESULTS AND FOLLOW-UP EXPERIENCE; CATHETER CARDIOVASC INTERVENTIONS. 2004; 62(4):499-505 REPORT COMPLICATIONS INCLUDED ONE STENT MIGRATION, ONE AORTIC DISSECTION AND ONE STENT FRACTURE OF PALMAZ STENTS USED IN THE STUDY. ONE CASE WAS COMPLICATED BY SUBOPTIMAL STENT PLACEMENT RESULTING IN ELECTIVE SURGICAL STENT REMOVAL AND SURGICAL COARCTATION REPAIR. THIS PATIENT WITH NATIVE COARCTATION HAD A DISCRETE STENOSIS BUT WITH LARGE PRE- AND POSTAORTIC DIAMETERS. THE BALLOON AND STENT POSITION COULD NOT BE MAINTAINED DURING INFLATION TO PREVENT DISTAL MIGRATION OF THE BALLOON AND STENT. ANOTHER PATIENT DEVELOPED DISSECTION OF THE AORTA WITH A LARGE PERIAORTIC HEMATOMA 2 DAYS FOLLOWING THE PROCEDURE. SURGICAL REPAIR WAS PERFORMED IN THIS CASE AS WELL. ANOTHER PATIENT HAD A RESIDUAL POSTOPERATIVE TRANSVERSE ARCH OBSTRUCTION. THE STENT DIAMETER DECREASED DURING THE INTERVAL BETWEEN PROCEDURES. THIS WAS DUE TO FRACTURE OF THE STENT THAT BECAME EVIDENT AT THE LAST CATHETERIZATION. HEPARIN M(50-100 UNITS/KG WAS GIVEN PRIOR TO LEFT HEART CATHETERIZATION AND THE ACTIVATED CLOTTING TIME WAS MONITORED WITH A GOAL OF GREATER THAN 200 SEC. HEMODYNAMIC DATA WERE OBTAINED AND ANGIOGRAPHIC MEASUREMENTS WERE PERFORMED. THE DIAMETER OF THE AORTA WAS MEASURED PROXIMAL AND DISTAL TO THE COARCTATION SITE IN ADDITION TO THE NARROWEST DIAMETER. ALL INTERVENTIONS WERE PERFORMED FROM THE RETROGRADE APPROACH. AN AMPLATZ SUPER STIFF WIRE ((B)(4)) WAS PLACED ACROSS THE SITE OF THE COARCTATION. ORIGINALLY, THE DISTAL TIP OF THE WIRE WAS POSITIONED IN EITHER THE ASCENDING AORTA OR THE LEFT VENTRICLE. RECENTLY, THE WIRE HAS BEEN POSITIONED IN THE LEFT CAROTID OR LEFT SUBCLAVIAN ARTERIES TO MAINTAIN A STRAIGHTER BALLOON STENT PROFILE, THEREBY REDUCING THE POTENTIAL FOR PUNCTURE OF THE BALLOON BY THE EDGE OF THE STENT. THIS GUIDEWIRE WAS USED TO POSITION AN 8 TO 12 FR SHEATH ACROSS...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216451 PALMAZ STENT LARGE ILIACR 30MM ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R