BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PTA

    MDR report key: 8345032 · Received February 15, 2019

    Report

    Report Number
    9616099-2019-02718
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 1, 2003
    Report Date
    February 15, 2019
    Manufacturer
    CORDIS CASHEL
    Product Code
    LIT
    PMA / PMN Number
    K981407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: A 0.014 INCH, 300 CM MICROGUIDEWIRE (CHOICE PT, BOSTON SCIENTIFIC CO), (SAVVY, CORDIS EUROPA, (B)(4)), SELF-EXPANDABLE STENTS: IN SEVEN PATIENTS, SMART BILIARY STENTS (CORDIS CORPORATION) WERE USED AND IN ONE PATIENT, EASYWALL STENT (BOSTON SCIENTIFIC) WAS USED. DISTAL PROTECTION BALLOON (NAVIBALLOON, KANEKA MEDIX CO) AND POST DILATATION WITH A POWERFLEX (CORDIS EUROPA) OR OPTA (CORDIS EUROPA). (B)(4). (B)(6). THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: FUKUDA ET AL., (2003). STAGED CAROTID STENTING AND CAROTID ENDARTERECTOMY FOR BILATERAL INTERNAL CAROTID ARTERY STENOSIS PRELIMINARY EXPERIENCE. INTERVENTIONAL NEURORADIOLOGY 9 (SUPPL1): 143-148. THE DEVICE IS EITHER A POWERFLEX OR AN OPTA BALLOON CATHETER BUT THE CATALOG AND LOT NUMBERS ARE UNKNOWN. AS REPORTED IN THE LITERATURE BY FUKUDA ET AL., (2003). STAGED CAROTID STENTING AND CAROTID ENDARTERECTOMY FOR BILATERAL INTERNAL CAROTID ARTERY STENOSIS PRELIMINARY EXPERIENCE. INTERVENTIONAL NEURORADIOLOGY 9 (SUPPL1): 143-148; ONE PATIENT HAD POSTPROCEDURAL PERSISTENT HYPOTENSION. CONTINUOUS INFUSION OF DOPAMINE AND DOBUTAMINE WAS REQUIRED FOR A FEW DAYS. THE PROCEDURE WAS A CAROTID ARTERY STENTING. AFTER DIAGNOSTIC ANGIOGRAPHY, 9 FR GUIDING CATHETER BRITETIP WAS INSERTED TO COMMON CAROTID ARTERY JUST PROXIMAL TO THE LESION. PREDILATION WAS PERFORMED USING A SAVVY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. POSTDILATION WAS PERFORMED BY USING A PTA BALLOON SUCH AS POWERFLEX OR OPTA. THE PATIENT INITIALLY PRESENTED WITH A MINOR STROKE AND WAS SYMPTOMATIC ON THE RIGHT SIDE. PERCENTAGE OF STENOSIS WAS RT. 99/LT. 75. ANGIO RISK WAS LT. SIPHON STENOSIS. OTHER RADIOLOGICAL FINDINGS WERE RT. CBF MILD REDUCTION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CAROTID STENT IMPLANTATION. A REVIEW OF LITERATURE INDICATES 40/% OF PATIENTS UNDERGOING CAS SUSTAINED A REACTION SECONDARY TO CAROTID BODY STIMULATION DURING BALLOON INFLATION, MOST COMMONLY SHORT-TERM HYPOTENSION WITHOUT CLINICAL SYMPTOMS, NOT ASSOCIATED TO PERIPROCEDURAL CEREBRAL COMPLICATIONS. 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 TWO REPORTS ASSOCIATED WITH THE REPORTED EVENT BUT THE SECOND REPORT NUMBER IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE BY FUKUDA ET AL., (2003). STAGED CAROTID STENTING AND CAROTID ENDARTERECTOMY FOR BILATERAL INTERNAL CAROTID ARTERY STENOSIS PRELIMINARY EXPERIENCE. INTERVENTIONAL NEURORADIOLOGY 9 (SUPPL1): 143-148; ONE PATIENT HAD POSTPROCEDURAL PERSISTENT HYPOTENSION. CONTINUOUS INFUSION OF DOPAMINE AND DOBUTAMINE WAS REQUIRED FOR A FEW DAYS. THE PROCEDURE WAS A CAROTID ARTERY STENTING. AFTER DIAGNOSTIC ANGIOGRAPHY, 9 FR GUIDING CATHETER BRITETIP WAS INSERTED TO COMMON CAROTID ARTERY JUST PROXIMAL TO THE LESION. PREDILATION WAS PERFORMED USING A SAVVY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. POSTDILATION WAS PERFORMED BY USING A PTA BALLOON SUCH AS POWERFLEX OR OPTA. THE PATIENT INITIALLY PRESENTED WITH A MINOR STROKE AND WAS SYMPTOMATIC ON THE RIGHT SIDE. PERCENTAGE OF STENOSIS WAS RT. 99/LT. 75. ANGIO RISK WAS LT. SIPHON STENOSIS. OTHER RADIOLOGICAL FINDINGS WERE RT. CBF MILD REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138279 UNKNOWN PTA CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS CASHEL N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R