BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1861994 · Received October 8, 2010

    Report

    Report Number
    9616099-2010-00778
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THE COMPLAINT RECEIVED FOR THE (B)(4) STUDY INDICATES FOLLOWING POST-DILATATION, THE PATIENT HAD APHASIA, DIAGNOSED AS A TIA ON THE LEFT SIDE WITH SYMPTOMS ON THE RIGHT. THE COMPLICATION BECAME CLINICALLY AND ANGIOGRAPHICALLY APPARENT AFTER FILTER REMOVAL. THE ONSET WAS SUDDEN AND WAS TREATED WITH VOLUME EXPANSION WITH FULL RECOVERY WITHIN 24 HOURS. THE PATIENT HAD RIGHT SIDED NUMBNESS AND WEAKNESS AND DIFFICULTY WITH WORD FINDING SYMPTOMS PRIOR TO THE PROCEDURE. PTA WAS PERFORMED ON AN 80% LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 12MM IN LENGTH IN A 4.4MM VESSEL DIAMETER WITH MILD VESSEL TORTUOUSITY. THE ARCH I LESION WAS ECCENTRIC AND MODERATELY CALCIFIED. A 5MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED AND THE LESION WAS PRE-DILATED. THEN A 7X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE RESIDUAL DIAMETER STENOSIS MEASURED 15%. THE PATIENT HAD NO KNOWN ALLERGIES TO NITINOL, NICKEL OR TITANIUM. THERE WAS A TIGHT SEAL BETWEEN THE SDS AND THE TOUGHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/ GUIDING CATHETER DURING ASPIRATION AND THE USER ASPIRATED PRIOR TO CONTRAST INJECTIONS. AIR BUBBLES WERE NOT NOTED AT ANY TIME DURING THE PROCEDURE. THROMBUS WAS NOT NOTED PRE OR POST-DEPLOYMENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15125281 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. APHASIA, AS A SYMPTOM OF TIA, IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY COLLECT IN THE EMBOLIC PROTECTION DEVICE POTENTIALLY DISRUPTING PERFUSION. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED FOR THE (B)(4) STUDY INDICATES FOLLOWING POST-DILATATION, THE PATIENT HAD APHASIA, DIAGNOSED AS A TIA ON THE LEFT SIDE WITH SYMPTOMS ON THE RIGHT. THE COMPLICATION BECAME CLINICALLY AND ANGIOGRAPHICALLY APPARENT AFTER THE FILTER REMOVAL. HEAD ANGIOGRAM WAS NORMAL BEFORE STENT PROCEDURE. IT WAS TREATED WITH VOLUME EXPANSION. THE PATIENT ALSO HAD RIGHT SIDED NUMBNESS AND WEAKNESS AND DIFFICULTY WITH WORD FIND SYMPTOMS PRIOR TO THE PROCEDURE. THE ONSET WAS SUDDEN WITH FULL RECOVERY WITHIN 24 HOURS. PTA WAS PERFORMED ON AN 80% LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 12MM IN LENGTH IN A 4.4MM VESSEL DIAMETER WITH MILD VESSEL TORTUOUSITY. THE ARCH I LESION WAS ECCENTRIC AND MODERATELY CALCIFIED. A 5MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED AND THE LESION WAS PRE-DILATED. THEN A 7X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE RESIDUAL DIAMETER STENOSIS MEASURED 15%. THE PATIENT HAD NO KNOWN ALLERGIES TO NITINOL, NICKEL OR TITANIUM. THERE WAS A TIGHT SEAL BETWEEN THE SDS AND THE TOUGHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/ GUIDING CATHETER DURING ASPIRATION AND THE USER ASPIRATED PRIOR TO CONTRAST INJECTIONS. AIR BUBBLES WERE NOT NOTED AT ANY TIME DURING THE PROCEDURE. THROMBUS WAS NOTED PRE OR POST-DEPLOYMENT. THE COMPLICATION BECAME CLINICALLY AND ANGIOGRAPHICALLY APPARENT AFTER THE FILTER REMOVAL. HEAD ANGIOGRAM WAS NORMAL BEFORE STENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15125281

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 5MM ANGIOGUARD EMBOLIC PROTECTION DEVICE