BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2030141 · Received March 28, 2011

    Report

    Report Number
    9616099-2011-00205
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(4) REGISTRY THE PATIENT EXPERIENCED AN ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA). AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 99% OCCLUSION IN THE LEFT MID INTERNAL CAROTID ARTERY. THE LESION WAS 42MM IN LENGTH AND THE VESSEL DIAMETER WAS 4.72MM. THE LESION WAS CONCENTRIC, ULCERATED, AND MODERATELY CALCIFIED. THE VESSEL WAS MILDLY TORTUOUS WITH AN ARCH TYPE II. BASELINE NIH STROKE SCALE SCORE WAS 1 AND RANKIN SCORE WAS 2. A 5MM ANGIOGUARD RX WAS UNABLE TO CROSS THE TARGET LESION DUE TO THE TIGHT LESION AND ALTHOUGH THE STUDY PARAMETERS REQUIRE IT, NO OTHER EMBOLIC PROTECTION DEVICE WAS USED. THE LESION WAS PRE-DILATED AND A 7.0 X 30MM PRECISE PRO RX AND A 6.0 X 40MM PRECISE PRO RX WERE IMPLANTED AT THE TARGET LESION. THE STENT WAS POST-DILATED AT 10ATM. THE TOTAL STENTED SEGMENT WAS 70MM. IT WAS REPORTED THAT THERE WAS A NEUROLOGICAL DEFICIT, BUT THE PHYSICIAN WAS UNABLE TO PINPOINT WHEN THE SYMPTOMS BEGAN. THE PATIENT WAS UNABLE TO ANSWER QUESTIONS APPROPRIATELY OR SQUEEZE A TOY WITH HIS RIGHT HAND, AND HAD COGNITIVE ISSUES (JUDGMENT AND INSIGHT LIMITED) AT THE END OF THE PROCEDURE. A CT SCAN DID NOT SHOW HEMORRHAGE, BUT THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC CVA AND RECEIVED PHYSICAL THERAPY AND OCCUPATIONAL THERAPY WITH MINOR RESIDUAL SYMPTOMS. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE WITH NIH STROKE SCALE SCORE OF 9 AND RANKIN SCORE OF 5. AT THE 30 DAYS VISIT, NIH SCORE WAS 3 AND RANKIN WAS 4. THE PATIENT'S MEDICAL HISTORY INCLUDES TRANSIENT ISCHEMIC ATTACK, HYPERTENSION AND POST RADIATION TREATMENT. THE DEVICES WERE IMPLANTED AND, THEREFORE, NOT AVAILABLE FOR ANALYSIS. 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. THE FUNCTION OF AN EMBOLIC PROTECTION DEVICE IS TO CAPTURE DEBRIS DURING THE CAROTID PROCEDURE AND PREVENT IT FROM EMBOLIZING DOWNSTREAM INTO THE PATIENTS VASCULATURE. IF ENOUGH DEBRIS IS DISLODGED FROM THE ARTERIAL WALL DURING THE PROCEDURE, IT MAY INTERFERE WITH NORMAL BLOOD FLOW RESULTING IN HYPOPERFUSION. THIS IS AN INHERENT RISK OF THE PROCEDURE IF AN EMBOLIC PROTECTION DEVICE IS NOT UTILIZED. 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, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00204 AND 9616099-2011-00205.

    Additional Manufacturer Narrative · 1

    A CT SCAN DID NOT SHOW HEMORRHAGE, BUT THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC CVA AND RECEIVED PHYSICAL THERAPY AND OCCUPATIONAL THERAPY WITH MINOR RESIDUAL SYMPTOMS. CK WAS ELEVATED POST-PROCEDURE TO 413 (ULN 200), BUT THERE WERE NO CARDIAC EVENTS REPORTED. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE WITH NIH STROKE SCALE SCORE OF 9 AND RANKIN SCORE OF 5. AT THE 30 DAYS VISIT NIH SCORE WAS 3 AND RANKIN WAS 4. CONCOMITANT MEDICAL DEVICE INCLUDED 6.0 X 40MM PRECISE PRO RX, MEDTRONIC SPRINTER LEGEND BALLOON, MAVERICK BALLOON. CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, HEPARIN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00204 AND 9616099-2011-00205.

    Additional Manufacturer Narrative · 1

    THE ALERT DATE FOR THE STROKE SHOULD BE CORRECTED FROM (B)(6) 2011 AS PREVIOUSLY REPORTED TO (B)(6) 2011. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00204 AND 9616099-2011-00205.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, AN ANGIOGUARD RX COULD NOT CROSS THE TARGET LESION AND THE PATIENT EXPERIENCED AN ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA). AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 99% OCCLUSION IN THE LEFT MID INTERNAL CAROTID ARTERY. THE LESION WAS 42MM IN LENGTH AND THE VESSEL DIAMETER WAS 4.72MM. THE LESION WAS CONCENTRIC, ULCERATED, AND MODERATELY CALCIFIED. THE VESSEL WAS MILDLY TORTUOUS WITH AN ARCH TYPE II. BASELINE NIH STROKE SCALE SCORE WAS 1 AND RANKIN SCORE WAS 2. A 5MM ANGIOGUARD RX WAS UNABLE TO CROSS THE TARGET LESION DUE TO THE TIGHT LESION AND NO OTHER EMBOLIC PROTECTION DEVICE WAS USED. THE LESION WAS PRE-DILATED WITH A MEDTRONIC SPRINTER LEGEND BALLOON AND A 7.0 X 30MM PRECISE PRO RX AND A 6.0 X 40MM PRECISE PRO RX WERE IMPLANTED AT THE TARGET LESION. THE STENT WAS POST-DILATED WITH A MAVERICK BALLOON AT 10ATM. THE TOTAL STENTED SEGMENT WAS 70MM. IT WAS REPORTED THAT THERE WAS A NEUROLOGICAL DEFICIT, BUT THE PHYSICIAN WAS UNABLE TO PINPOINT WHEN THE SYMPTOMS BEGAN. THE PATIENT WAS UNABLE TO ANSWER QUESTIONS APPROPRIATELY OR SQUEEZE A TOY WITH HIS RIGHT HAND, AND HAD COGNITIVE ISSUES (JUDGMENT AND INSIGHT LIMITED) AT THE END OF THE 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 15034215

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention| S