BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3932501 · Received July 14, 2014

    Report

    Report Number
    9616099-2014-00465
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    March 1, 2010
    Report Date
    June 19, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE OF (B)(6) 2010 AS THE EXACT DATE OF PUBLICATION IS NOT AVAILABLE. THE PRODUCTS ARE NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 4 SEPARATE EVENTS INVOLVING IPSILATERAL STROKE AT ONE YEAR FROM A LITERATURE REVIEW SOURCE AND FOR WHICH SPECIFIC PATIENT INFORMATION WAS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. FOR THIS LITERATURE ARTICLE FILE, PLEASE REFERENCE MFR. REPORTS: # 9616099-2014-00461; 1016427-2014-00077; 9616099-2014-00462; 9616099-2014-00463; 9616099-2014-00464; 9616099-2014-00465; 9616099-2014-00466.

    Additional Manufacturer Narrative · 1

    AN ARTICLE FOUND DURING A LITERATURE REVIEW: ENDOVASCULAR THERAPY OF CAROTID ARTERY STENOSIS: A PROSPECTIVE CASE STUDY. EVENTS NOTED WERE THIRTY DAY COMPLICATIONS (INFARCT (N=9, ALL DURING THE PROCEDURE), HEMORRHAGE (N=4, AFTER 12 H, 20 H, 2 DAYS AND 3 DAYS) AND DEATH DUE TO EITHER COMPLICATION (N=2) WERE SEEN IN 13 CASES (6.8%). ONE HUNDRED AND TWENTY-NINE OF THE 190 PATIENTS WERE REINVESTIGATED WITHIN 430 DAYS. SEVEN (5.4%) RECIDIVE STENOSES WERE SEEN (FOUR >50% (3.1%) AND THREE <50% (2.3%)). ALL WERE ASYMPTOMATIC. ONLY TWO OF THE RECIDIVE STENOSES DEVELOPED AFTER > OR EQUAL TO 60 DAYS. STROKE RECIDIVES WERE SEEN IN SIX OF THE 166 PATIENTS WHO WERE FOLLOWED FOR 1 YEAR BETWEEN DAYS 31 AND 365 (FOUR IPSILATERAL (2.4%), ONE CONTRALATERAL INFARCTION AND ONE HEMORRHAGE) (3.6% 1 YEAR RISK). IN ADDITION, THERE WERE 11 TIA EVENTS AT AN UNKNOWN TIME. THE PRODUCTS WERE NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORDS (DHR) COULD NOT BE REVIEWED, AS THE PRODUCT CATALOG AND LOT NUMBER ARE NOT AVAILABLE. THE EVENTS CAPTURED IN THE ARTICLE OF: STROKE, CVA, HEMORRHAGIC STROKE, CAROTID ARTERY OCCLUSION, AND ARTERIAL RESTENOSIS ARE ALL KNOWN COMPLICATIONS OF INTERVENTIONAL PROCEDURES/STENT IMPLANTATION/CAROTID ARTERY STENTING PROCEDURES AND ARE NOTED IN THE INSTRUCTIONS FOR USE. THE EVENTS 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. 80% 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. ARTERIAL RESTENOSIS/CAROTID ARTERY OCCLUSION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CAROTID ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CAROTID ARTERY DISEASE. 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. FOR THIS LITERATURE ARTICLE FILE, PLEASE REFERENCE MFR. REPORTS: # 9616099-2014-00461; 1016427-2014-00077; 9616099-2014-00462; 9616099-2014-00463; 9616099-2014-00464; 9616099-2014-00465; 9616099-2014-00466.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY CLAUS ET AL ENDOVASCULAR THERAPY OF CAROTID ARTERY STENOSIS: A PROSPECTIVE CASE STUDY, J NEUROINTERV SURGERY 2 (2010) 59-64; THIRTY DAY COMPLICATIONS (INFARCT (N=9, ALL DURING THE PROCEDURE), HEMORRHAGE (N=4, AFTER 12 H, 20 H, 2 DAYS AND 3 DAYS) AND DEATH DUE TO EITHER COMPLICATION (N=2) WERE SEEN IN 13 CASES (6.8%). ONE HUNDRED AND TWENTY-NINE OF THE 190 PATIENTS WERE REINVESTIGATED WITHIN 430 DAYS. SEVEN (5.4%) RECIDIVE STENOSES WERE SEEN (FOUR >50% (3.1%) AND THREE <50% (2.3%)). ALL WERE ASYMPTOMATIC. ONLY TWO OF THE RECIDIVE STENOSES DEVELOPED AFTER > OR EQUAL TO 60 DAYS. STROKE RECIDIVES WERE SEEN IN SIX OF THE 166 PATIENTS WHO WERE FOLLOWED FOR 1 YEAR BETWEEN DAYS 31 AND 365 (FOUR IPSILATERAL (2.4%), ONE CONTRALATERAL INFARCTION AND ONE HEMORRHAGE) (3.6% 1 YEAR RISK). IN ADDITION, THERE WERE 11 TIA EVENTS AT AN UNKNOWN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411132 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening