BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 4205872 · Received October 28, 2014

    Report

    Report Number
    9616099-2014-00692
    Event Type
    Injury
    Date Received
    October 28, 2014
    Date of Event
    May 1, 2013
    Report Date
    October 2, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LITERATURE CITATION BARBIERO ET AL (2012, SEPTEMBER, 26). CAROTID ARTERY STENTING IN DIFFICULTY AORTIC ARCH ANATOMY WITH OR WITHOUT A NEW DEDICATED GUIDING CATHETER: PRELIMINARY EXPERIENCE. EUR RADIOLOGY, 23, 1420-1428. THERE IS NO DEMOGRAPHIC OR DEVICE SPECIFICS BASED ON THE PUBLICATION. THE PUBLICATION HAS BEEN ATTACHED TO THE MEDWATCH REPORTS. ALL PATIENTS WERE MEDICATED WITH ASPIRIN 100MG AND CLOPIDOGREL 75MG FOR 3 DAYS BEFORE THE PROCEDURE AND WITH SYSTEMIC HEPARINIZATION (5,000 IU OF HEPARING) DURING THE PROCEDURE. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FOUR PRODUCTS INVOLVED WITH THESE EVENTS WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2014-00691, 9616099-2014-00692, 9616099-2014-00693 AND 9616099-2014-00694.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN A PUBLICATION, CAROTID ARTERY STENTING IN DIFFICULT AORTIC ARCH ANATOMY WITH OR WITHOUT A NEW DEDICATED GUIDING CATHETER: PRELIMINARY EXPERIENCE TECHNICAL FAILURE OCCURRED IN 3 OUT OF THE (B)(4) CASES OF DIFFICULT ANATOMY BECAUSE OF UNSTABLE CANNULATION OF THE CCA TARGET WITH THE STANDARD GUIDING CATHETERS (UNKNOWN CORDIS). FOUR (4) PATIENTS DEVELOPED NEUROLOGICAL COMPLICATIONS 24 HOURS POST-PROCEDURE (2 TIA AND 2 MINOR STROKES). TWO LOCAL COMPLICATIONS IN THE PUNCTURE SITE OCCURRED IN GROUP S AND REQUIRED SURGICAL INTERVENTION: ONE PSEUDOANEURYSM AND ONE DISSECTION OF THE CFA; NO LOCAL COMPLICATIONS WERE REPORTED IN GROUP D. THE COMMON FEMORAL ARTERY WAS PERCUTANEOUSLY OR SURGICALLY PUNCTURED AND A 7F OR 8F CORDIS SHEATH WAS INSERTED. THE PRODUCTS ARE NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEWS COULD NOT BE PERFORMED. VESSEL DISSECTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PERFORMING DIAGNOSTIC AND INTERVENTIONAL ANGIOGRAPHIC PROCEDURES. VESSEL PERFORATION IS LISTED IN THE IFU AS A POTENTIAL COMPLICATION. WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO ESTABLISH A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE CORDIS SHEATH. THERE IS NO INDICATION THAT THE DEVICE DID NOT PERFORM AS INTENDED OR THAT IT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDE PATIENT, PROCEDURAL, AND VESSEL CHARACTERISTICS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PSEUDOANEURYSM IS A KNOWN POTENTIAL ADVERSE EVENT. THE IFU LISTS PROLONGED ACCESS SITE-RELATED BLEEDING AS A POTENTIAL RISK ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. ACCESS SITE RETROPERITONEAL BLEEDS/HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS TO THIS EVENT. THERE IS NO INDICATION THAT THE DEVICE DID NOT PERFORM AS INTENDED OR THAT IT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU AS SUCH. 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 OR FLOW DOWNSTREAM POTENTIALLY DISRUPTING PERFUSION BOTH DURING AND AFTER CAROTID STENT IMPLANTATION. BY DEFINITION (MAYOCLINIC.ORG), THE SYMPTOMS OF A TIA MAY LAST UP TO 24 HOURS, BUT THEY OFTEN LAST ONLY A FEW MINUTES. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. MOST SYMPTOMS OF A TIA DISAPPEAR WITHIN AN HOUR. 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. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT 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 % 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. THERE IS NO INDICATION THAT THE DEVICE DID NOT PERFORM AS INTENDED OR THAT IT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN A PUBLICATION, CAROTID ARTERY STENTING IN DIFFICULT AORTIC ARCH ANATOMY WITH OR WITHOUT A NEW DEDICATED GUIDING CATHETER: PRELIMINARY EXPERIENCE TECHNICAL FAILURE OCCURRED IN 3 OUT OF THE 37 CASES OF DIFFICULT ANATOMY BECAUSE OF UNSTABLE CANNULATION OF THE CCA TARGET WITH THE STANDARD GUIDING CATHETERS (UNKNOWN CORDIS). FOUR (4) PATIENTS DEVELOPED NEUROLOGICAL COMPLICATIONS 24 HOURS POST-PROCEDURE (2 TIA AND 2 MINOR STROKES). TWO LOCAL COMPLICATIONS IN THE PUNCTURE SITE OCCURRED IN GROUP S AND REQUIRED SURGICAL INTERVENTION: ONE PSEUDOANEURYSM AND ONE DISSECTION OF THE CFA; NO LOCAL COMPLICATIONS WERE REPORTED IN GROUP D. THE COMMON FEMORAL ARTERY WAS PERCUTANEOUSLY OR SURGICALLY PUNCTURED AND A 7F OR 8F CORDIS SHEATH WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688423 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening