BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRITY RX

    MDR report key: 3152996 · Received June 8, 2013

    Report

    Report Number
    9612164-2013-00613
    Event Type
    Death
    Date Received
    June 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE-DISSECTION; PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE- THE PATIENT MAY HAVE BEEN PRE-DISPOSED TO THROMBOLYTIC EVENTS. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: INHERENT RISK OF PROCEDURE-DISSECTION; DEVICE FAILURE RELATED TO PATIENT CONDITION- THE PATIENT MAY HAVE BEEN PRE-DISPOSED TO THROMBOLYTIC EVENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF A STENTING PROCEDURE (DEATH, THROMBOSIS, MYOCARDIAL INFARCTION); CONCLUSION: RISK OF A STENTING PROCEDURE (DEATH, THROMBOSIS, MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    IMAGE REVIEW : THE INDEX PROCEDURE ON THE (B)(6) SHOWS TREATMENT OF AN OCCLUDED DISTAL RCA CONSISTENT WITH AN AMI PRESENTATION. THROMBUS IS EVIDENT IN THE VESSEL. THREE LESIONS WERE OBSERVED IN THE VESSEL. WITH BALLOONING OF THE 1ST AND 2ND LESIONS. THE 3RD LESION WAS NOT TREATED AS IT WAS NOT FLOW LIMITING. A STENT WAS DEPLOYED ACROSS THE 2ND LESION. THE VESSEL IS BALLOONED AND THE MID LESION WAS STENTED. FINAL ANGIO SHOWS GOOD LUMEN FOR FIRST LESION, IRREGULAR WALL AT SECOND LESION CONSISTENT WITH EITHER A LACK OF FULL STENT APPOSITION OR LOCALIZED DISSECTION, AND A THIRD LESION PRIOR TO POSTERIOR LV BRANCH THAT IS 50% AND ECCENTRIC SUGGESTIVE OF ULCERATED LESION. LV SHOWS INFERIOR WALL HYPO AND AKINESIA. FOLLOW-UP ANGIO (B)(6) SHOWS THROMBUS IN MID-RCA PROXIMAL TO STENT SITE WITH OCCLUSION OF VESSEL AT PROXIMAL STENT/VESSEL JUNCTION. CLOT OCCUPIES A LONG SEGMENT OF THE RCA. NO ANGIOS SHOWN OF ATTEMPTS TO CLOT EXTRACT OR OCCLUSION RELIEF. IT IS UNCLEAR WHAT COURSE OF EVENTS HAPPENED SUBSEQUENTLY ALTHOUGH THE OFFERED NOTES SAY THAT NUMEROUS ATTEMPTS TO CROSS WERE TRIED BUT FAILED. THIS WOULD SUGGEST A MECHANICAL INFLOW OBSTRUCTION TO THE STENT SUCH AS A DISSECTION AT THE PROXIMAL MOUTH OF THE STENT, AS USUALLY IT IS EASY TO ACCESS A THOMBOSED STENT. THE ANGIO WOULD BE CONSISTENT WITH THIS. REVIEW OF THE FIRST PROCEDURAL FILM DOES NOT SHOW THIS AS PRESENT AT THE END OF THE FIRST TREATMENT.

    Description of Event or Problem · 1

    AN INTEGRITY BARE METAL STENT WAS PLACED IN PATIENT¿S MID-RIGHT CORONARY ARTERY WHICH WAS REPORTED TO BE A TYPE C LESION, TORTUOUS WITH A SHEPHERDS CROOK. THE STENT WAS PLACED FOLLOWING THROMBECTOMY AND PRE DILATATION. THERE WAS NO EVIDENCE OF VESSEL DAMAGE AND/OR THROMBUS AT THE SITE OF DEPLOYMENT IMMEDIATELY AFTER DEPLOYMENT. APPROXIMATELY 6 DAYS LATER, THE PATIENT RETURNED WITH CHEST PAIN AND THE STENT WAS FOUND TO HAVE THROMBOSED. THE PATIENT BECAME TOO UNSTABLE AND DIED PRIOR TO ANY INTERVENTION. STENT THROMBOSED AND IS BELIEVED TO HAVE CAUSED FATAL HEART ATTACK. INTERVENTIONALIST STATES, ¿NOT SURE IF THERE WAS A RELATIONSHIP OR NOT ¿ TO THE INTEGRITY STENT. IMAGE REVIEW: THE INITIAL PROCEDURE IMAGES CONFIRM THE PRESENCE OF A THROMBUS. SIX DAYS LATER, WHEN THE PATIENT RETURNED THE VESSEL WAS RE-OCCLUDED MOST LIKELY DUE TO THROMBOSIS. IT IS NOT KNOWN IF THE PATIENT WAS RESISTANT TO THE ANTIPLATELET MEDICATION THAT WAS PRESCRIBED. THERE WAS NO EVIDENCE OF STENT DEFORMATION OR MALFUNCTION THAT COULD CONTRIBUTE TO THROMBUS FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254353 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death TICAGRELOR