BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1834086 · Received September 14, 2010

    Report

    Report Number
    9616099-2010-00689
    Event Type
    Death
    Date Received
    September 14, 2010
    Date of Event
    January 12, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K041796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. PLEASE NOTE THAT THE PRODUCT CATALOG NUMBER IS NOT KNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE E-MAIL RECEIVED FROM THE (B)(4) REGISTRY INDICATED THAT APPROXIMATELY NINE MONTHS POST INDEX PROCEDURE, THE PATIENT DIED ON AN UNKNOWN CAUSE. IT WAS INDICATED AS UNRELATED TO THE CORDIS DEVICE AND UNRELATED TO THE PROCEDURE. HOWEVER, THE CAUSE OF DEATH IS NOT KNOWN. WITH INVESTIGATION, IT WAS REPORTED THAT WITH ATTEMPT TO OBTAIN ADDITIONAL INFORMATION IT APPEARS THAT THE PATIENT WAS NOT AT THE HOSPITAL AT THE TIME OF DEATH AND THERE IS NO FURTHER INFORMATION AND IS NOT AVAILABLE VIA THE DEATH CERTIFICATE. AT INDEX PROCEDURE THE (B)(6) MALE HAD A HISTORY OF HYPERLIPIDEMIA, CLINICAL COPD, HISTORY OF SMOKING, HYPERTENSION, KNOWN TWO OR MORE PROXIMAL OR MAJOR DISEASED CORONARY ARTERIES WITH >70% STENOSIS WITHOUT REVASCULARIZATION. THE BASELINE (B)(6) SCORE WAS 3. (B)(6) SCORE WAS NOT DOCUMENTED THE 90% PROXIMAL LEFT CAROTID LESION WAS 18MM IN LENGTH ULCERATED WITH MODERATE CALCIFICATION. A 5MM ANGIOGUARD WAS DEPLOYED. THE LESION WAS PRE-DILATED WITH NO DOCUMENTED RESISTANCE. A 9X40 PRECISE WAS IMPLANTED AT THE TARGET SITE. THE ANGIOGUARD WITH WITHDRAWN WITH NO DEBRIS. IT WAS INDICATED THAT THERE WERE NO TECHNICAL DIFFICULTIES AND NO ASSOCIATED ADVERSE EVENTS. FINAL TARGET LESION STENOSIS WAS 10%. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT AND WAS DISCHARGED THE FOLLOWING DAY WITH (B)(6) SCORE OF 3 AND (B)(6) SCALE OF 3. ANTI-PLATELET THERAPY INCLUDED PRE AND POST PROCEDURE CLOPIDOGREL AND ASPIRIN. FOLLOW-UP CONTACT TEN DAYS LATER REPORTED NO ADVERSE EVENT. THE STENT REMAINS IMPLANTED AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD CANNOT BE REVIEWED. THIS PATIENT'S MEDICAL HISTORY AND COMORBIDITIES PUT HIM AT RISK FOR MAJOR ADVERSE EVENT. BASED ON THE LACK OF INFORMATION PERTAINING TO THE PATIENT'S DEATH NINE MONTHS POST CAROTID STENTING, A RELATIONSHIP TO THE IMPLANTED PRECISE STENT CANNOT BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 9 MONTHS AFTER HAVING A STENT PLACED IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY, THE PATIENT EXPIRED. THE ADJUDICATION MINUTES FOR THIS EVENT HAVE DETERMINED THAT THE ETIOLOGY FOR THE PATIENT'S DEATH WAS UNRELATED TO BOTH THE PRECISE STENT AND THE INDEX PROCEDURE AND WAS NOT CARDIAC OR NEUROLOGICAL IN NATURE. THE CAUSE OF DEATH WAS IDENTIFIED AS "OTHER". ACCORDING TO THE MINUTES THE PATIENT HAD MULTIPLE HOSPITAL ADMISSIONS IN THE MONTHS PRIOR TO HIS DEMISE FOR A VARIETY OF NON-NEUROLOGICAL MEDICAL EVENTS. BASED ON THIS INFORMATION THIS EVENT WAS DETERMINED TO BE A NON-COMPLAINT AND THEREFORE NO LONGER CONSIDERED MDR REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE DEVICE LOCKED OUT AND SOME STAPLES FELL OUT OF THE CARTRIDGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    THE E-MAIL RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY NINE MONTHS POST INDEX PROCEDURE, THE PATIENT DIED OF UNKNOWN CAUSE. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death ANGIOGUARD EMBOLIC PROTECTION.