BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2183649 · Received July 29, 2011

    Report

    Report Number
    9616099-2011-00561
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: ANGIOGUARD RX CATALOG NUMBER 601814RMC, LOT NUMBER 70211510. CONCOMITANT MEDICATIONS: PRE AND POST-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN. HEPARIN WAS USED DURING THE PROCEDURE. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT ONE DAY FOLLOWING THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITH AN NIH STROKE SCALE SCORE OF 7 AND WAS REFERRED TO REHAB FOR PHYSICAL, OCCUPATIONAL AND SPEECH THERAPY. PTA WAS PERFORMED ON A 99% OCCLUDED LESION AT THE BIFURCATION OF THE RIGHT INTERNAL CAROTID ARTERY. THE ARCH LESION WAS ULCERATED AND MODERATELY CALCIFIED. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED FOLLOWED BY DEPLOYMENT OF A PRECISE PRO RX STENT AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 20%. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT ANY TECHNICAL PROBLEMS. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES TO NITINOL, NICKEL OR TITANIUM. A 6 FR SIZE SHEATH INTRODUCER WAS USED IN THE PROCEDURE AND THERE WAS A TIGHT SEAL BETWEEN THE SDS AND THE TUOHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/GUIDING CATHETER DURING ASPIRATION. THE USER ASPIRATED PRIOR TO CONTRAST INJECTIONS. AIR BUBBLES WERE NOT NOTED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO THROMBUS NOTED PRE OR POST-DEPLOYMENT. THE PATIENTS MEDICAL HISTORY INCLUDES SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE AND HYPERTENSION. 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 15310904 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. EIGHTY PERCENT OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. 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. PLEASE NOTE THAT THIS IS AN INITIAL AND FINAL REPORT. NO FURTHER INFORMATION IS AVAILABLE AND THEREFORE NO FURTHER REPORTS WILL BE FORTHCOMING AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT ONE DAY FOLLOWING THE INDEX PROCEDURE, THE PATIENT HAD HEMIPARESIS AND RIGHT HEMIATAXIA, DIAGNOSED AS AN ISCHEMIC STROKE. IT WAS A NEW ONSET CVA, NOW WITH BOTH LOWER EXTREMITY WEAKNESS; DIFFICULTY WITH AMBULATION; EXPRESSIVE APHASIA; DIFFICULTY WITH COMMUNICATION, SWALLOWING, PROBLEM SOLVING, AND MEMORY. THE ONSET WAS GRADUAL. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITH AN NIH STROKE SCALE SCORE OF 7. THE PATIENT WAS REFERRED TO REHAB FOR PHYSICAL, OCCUPATIONAL AND SPEECH THERAPY. AT BASELINE, THE NIH STROKE SCALE SCORE WAS 1. NEUROLOGIC EXAMINATION IMMEDIATELY PRIOR TO PROCEDURE REVEALED DECREASED VIBRATION SENSATION OF BOTH FEET, ABSENT JAW JERK, DTRS 2+ THROUGHOUT WITH 1+ BOTH ANKLE JERKS AND DOWNGOING TOES BILATERALLY. THE GAIT WAS NARROW BASED WITH THE PATIENT BEING UNABLE TO WALK TANDEM GAIT. PTA WAS PERFORMED ON A 99% OCCLUDED LESION AT THE BIFURCATION OF THE RIGHT INTERNAL CAROTID ARTERY OF 12MM IN LENGTH IN A 5.0MM VESSEL DIAMETER. THE ARCH LESION WAS ULCERATED AND MODERATELY CALCIFIED. A 6MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED FOLLOWED BY DEPLOYMENT OF A 7X30MM PRECISE PRO RX STENT AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 20%. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT ANY TECHNICAL PROBLEMS. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES TO NITINOL, NICKEL OR TITANIUM AND DID HAVE NEUROLOGICAL SYMPTOMS PRIOR TO THE PROCEDURE. A 6 FR SIZE SHEATH INTRODUCER WAS USED IN THE PROCEDURE AND THERE WAS A TIGHT SEAL BETWEEN THE SDS AND THE TUOHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/ GUIDING CATHETER DURING ASPIRATION. THE USER ASPIRATED PRIOR TO CONTRAST INJECTIONS. AIR BUBBLES WERE NOT NOTED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO THROMBUS NOTED PRE OR POST-DEPLOYMENT.

    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 15310904

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R| S