BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ BLUE ON AVIATOR PLUS

    MDR report key: 20332938 · Received September 30, 2024

    Report

    Report Number
    3007635982-2024-00237
    Event Type
    Death
    Date Received
    September 30, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 7, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    FGE
    UDI-DI
    10705032062206
    PMA / PMN Number
    K060877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, G3, G6, H1, H2, H3, H6, AND H11. COMPLAINT CONCLUSION: AS REPORTED, AFTER PERFORMING AN ATRIOSEPTOSTOMY ON A PATIENT DIAGNOSED WITH LEFT HEART HYPOPLASIA SYNDROME, AN INTERATRIAL STENT WAS IMPLANTED WITH A 6MM X 18MM PALMAZ BLUE ON AVIATOR PLUS STENT DELIVERY SYSTEM (SDS). THE STENT MIGRATED AND REQUIRED A CARDIOVASCULAR PROCEDURE. THE PATIENT WAS LATER RE-ADMITTED TO THE INTENSIVE CARE UNIT (ICU) IN A STATE OF MAXIMUM SEVERITY, MULTI-SUPPORTED WITH A VASOACTIVE SCORE. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS UNABLE TO BE PERFORMED DUE TO VALVULAR INJURY. ADVANCED CARDIOPULMONARY RESUSCITATION (CPR) LATER PERFORMED WITHOUT CLINICAL RESPONSE, AND THE PATIENT DIED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THE REPORTED ¿STENT MIGRATION¿ IS NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED NOR WERE PROCEDURAL IMAGES PROVIDED. THE DEVICE WAS USED DURING AN ATRIOSEPTOSTOMY PROCEDURE WHICH IS NOT LISTED AS AN INDICATION IN THE INSTRUCTIONS FOR USE. THE CORDIS PALMAZ BLUE .014" PERIPHERAL STENT SYSTEM IS INDICATED IN ENABLING TREATMENT OF PATIENTS WITH STENOTIC LESIONS IN THE RENAL ARTERIES, WHICH IS LISTED IN THE IFU AS SUCH. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADDITIONAL RISKS/ISSUES NOT DESCRIBED IN THE LABELING SUCH AS THE ADVERSE EVENT OF ¿CARDIAC VALVE INJURY¿ THAT OCCURRED. PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND PROCEDURAL FACTORS. ADDITIONALLY, SAFETY AND EFFECTIVENESS HAVE NOT BEEN DEMONSTRATED IN PEDIATRIC PATIENTS OR FOR INTERATRIAL STENT PLACEMENT. BASED ON THE AVAILABLE INFORMATION, IT IS UNCLEAR WHETHER THE PATIENT¿S DEATH WAS DUE TO THEIR OVERALL CONDITION, THE OFF-LABEL USE OF THE REPORTED DEVICE, OR ANOTHER PROCEDURAL COMPLICATION THAT PREVENTED THE PROVISION OF LIFE-SAVING SUPPORTIVE CARE (ECMO). ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED TO MITIGATE RISK, ¿THE USE OF THIS PRODUCT FOR PROCEDURES OTHER THAN THOSE INDICATED IN THESE INSTRUCTIONS IS NOT RECOMMENDED. IN THE EVENT OF COMPLICATIONS, SURGICAL REMOVAL OF THE STENT MAY BE REQUIRED. STANDARD SURGICAL PROCEDURE IS APPROPRIATE. POTENTIAL COMPLICATIONS ASSOCIATED WITH PERIPHERAL ARTERY STENT IMPLANTATION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: ANEURYSM, ALLERGIC REACTION TO STENT MATERIAL COBALT CHROMIUM OR ONE OF ITS COMPONENTS, OR TO CONTRAST MEDIUM, ARTERIOVENOUS FISTULA, CEREBROVASCULAR ACCIDENT/STROKE, DEATH, EMBOLIZATION (AIR, TISSUE, STENT, ATHEROSCLEROTIC OR THROMBOTIC MATERIAL, CHOLESTEROL), EMERGENCY SURGERY TO CORRECT VASCULAR COMPLICATIONS (REVASCULARIZATION/BYPASS), FAILURE TO DELIVER THE STENT TO THE INTENDED SITE, HEMORRHAGE/HEMATOMA, HYPERTENSION, HYPOTENSION, INFECTION/INFLAMMATION, MYOCARDIAL ISCHEMIA/INFARCTION AND ARRHYTHMIA, PERIPHERAL NEUROPATHY, PERSISTENT ABDOMINAL PAIN, RENAL INSUFFICIENCY, RENAL FAILURE/DIALYSIS, RENAL INFARCTION, RENAL TRANSPLANTATION/NEPHRECTOMY, RESTENOSIS OF THE STENTED ARTERY, RUPTURE OF RETROPERITONEUM OR NEIGHBORING ORGAN, TISSUE NECROSIS/ULCERATION, STENT MIGRATION/EMBOLIZATION, STENT THROMBOSIS/OCCLUSION, VASCULAR COMPLICATIONS (E.G. AT PUNCTURE AND/OR LESION SITE, DISSECTION, INTIMAL TEAR, PSEUDOANEURYSM, RUPTURE AND PERFORATION, SPASM, OCCLUSION).¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST THAT THE ISSUE REPORTED COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 0

    THE DATE OF THE PATIENT DEATH WAS NOT PROVIDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, AFTER PERFORMING AN ATRIOSEPTOSTOMY ON A PATIENT DIAGNOSED WITH LEFT HEART HYPOPLASIA SYNDROME, AN INTERATRIAL STENT WAS IMPLANTED WITH A 6MM X 18MM PALMAZ BLUE ON AVIATOR PLUS STENT DELIVERY SYSTEM (SDS). THE STENT MIGRATED AND REQUIRED A CARDIOVASCULAR PROCEDURE. THE PATIENT WAS LATER RE-ADMITTED TO THE INTENSIVE CARE UNIT (ICU) IN A STATE OF MAXIMUM SEVERITY, MULTI-SUPPORTED WITH A VASOACTIVE SCORE. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS UNABLE TO BE PERFORMED DUE TO VALVULAR INJURY. ADVANCED CARDIOPULMONARY RESUSCITATION (CPR) LATER PERFORMED WITHOUT CLINICAL RESPONSE, AND THE PATIENT DIED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585154 PALMAZ BLUE ON AVIATOR PLUS STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE CORDIS US. CORP 82300911 10705032062206

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA Female Hospitalization| D| R| C NA.