BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1664846 · Received April 22, 2010

    Report

    Report Number
    9616099-2010-00293
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 24, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.CONCOMITANT DEVICES INCLUDE A 6MM ANGIOGUARD RX.A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES OR ANOMALIES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. 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 1016427-2010-00044 AND 9616099-2010-00293.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00044 AND 9616099-2010-00293. THE EVALUATION CODES HAVE BEEN INCLUDED. AS REPORTED BY (B) (4) REGISTRY, THE PATIENT WITH A HISTORY OF HYPERLIPIDEMIA, SMOKING HISTORY, DIABETES MELLITUS, CORONARY ARTERY DISEASE, HYPERTENSION, BREAST CANCER, SEVERE PERIPHERAL VASCULAR DISEASE, PNEUMONIA, TRANSIENT ISCHEMIC ATTACK, AND ALLERGIES TO CODEINE, OXYCODONE, ACETAMINOPHEN, DIAZEPAM, HYDROCODONE, GRASS, PENICILLIN AND CONTRAST DYE EXPERIENCED A HEMORRHAGIC STROKE AND EXPIRED POST INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (ICA). CAROTID DUPLEX REVEALED OCCLUDED RIGHT INTERNAL CAROTID ARTERY AND 50-69% LEFT INTERNAL CAROTID ARTERY STENOSIS. THE LESION WAS DESCRIBED AS ECCENTRIC, CONCENTRIC, 25MM IN LENGTH, 70% STENOSED, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 5MM IN DIAMETER AND MODERATELY TORTUOUS. A 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION WHICH WAS PRE-DILATED FOLLOWED BY SUCCESSFUL IMPLANTATION OF AN 8X40M PRECISE PRO RX STENT. THE ANGIOGUARD RX WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 0%. INTRA-PROCEDURE THE PATIENT¿S MENTAL STATUS CHANGED AND HER BLOOD PRESSURE INCREASED REQUIRING MEDICATIONS. BY THE TIME THE PATIENT LEFT THE CATHETER LAB, SHE WAS COMPLETELY UNRESPONSIVE. THE PATIENT UNDERWENT EMERGENCY INTUBATION AND A CT SCAN REVEALED EXTENSIVE SUBARACHNOID HEMORRHAGE WITH POSSIBLE HERNIATION. THE PATIENT BECAME HYPOTENSIVE. CONSULTATIONS WITH CARDIOLOGY, NEUROLOGY, AND INTERNAL MEDICINE DETERMINED THE EVENT WAS LETHAL. THE FAMILY FELT THE PATIENT WOULD NOT WANT TO BE KEPT ALIVE AND THE PATIENT WAS TERMINALLY EXTUBATED AND WENT INTO ASYSTOLE. THE FAMILY DID NOT WANT AN AUTOPSY. MEDICAL RECORDS REVEALED THE PATIENT HAD PREVIOUSLY EXPERIENCED EPISODES OF WEAKNESS AND SLURRED SPEECH OVER THE PAST FEW YEARS. THE INVESTIGATOR CONFIRMED THE HEMORRHAGIC STROKE WAS NOT RELATED TO THE CORDIS PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT FOR BOTH DEVICES PRESENTED NO ISSUES OR ANOMALIES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NUMEROUS REPORTS HAVE SUBSEQUENTLY DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, AFTER CAROTID ANGIOPLASTY AND AFTER INTRACRANIAL ANGIOPLASTY. ESTIMATES OF THE INCIDENCE OF HYPERPERFUSION SYNDROME AFTER CAROTID REVASCULARIZATION RANGE UP TO 3%. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. EVIDENCE FROM OBSERVATIONAL STUDIES, IN LACK OF RANDOMIZED TRIALS, SUGGESTS THAT A NUMBER OF FACTORS-ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE, SUCH AS RECENT STROKE, SURGERY FOR VERY TIGHT INTERNAL CAROTID ARTERY STENOSIS, CONCOMITANT CONTRALATERAL TIGHT LESION, IMPAIRED CEREBROVASCULAR RESERVE (CEREBRAL HYPOPERFUSION), AND MARKED POSTOPERATIVE INCREASE OF IN IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE- AND POST-OPERATIVE HYPERTENSION. THE PATIENT WAS HEPARINIZED FOR THE PROCEDURE AND ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE FIRED PROPERLY USING A BLUE RELOAD HOWEVER THE PATIENT WAS BROUGHT BACK TO SURGERY FIVE HOURS LATER. THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN AND IT WAS DETERMINED THAT THERE WAS A LEAKING STAPLE LINE ON THE APPENDICEAL STUMP. SURGICAL GLUE SPRAY WAS USED TO REPAIR THE LEAK. IT WAS ALSO NOTED THAT THE DEVICE DURING THE ORIGINAL PROCEDURE HAD BEEN FIRED USING A WHITE RELOAD ON A VESSEL AND THE STAPLE LINE WAS INTACT AND NOT LEAKING. THE PATIENT HAS BEEN DISCHARGED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE, THE SURGEON DOES NOT WISH TO DISCUSS THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY (B) (4) REGISTRY, THE PATIENT EXPERIENCED A STROKE AND EXPIRED DURING THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS ECCENTRIC, CONCENTRIC, 25MM IN LENGTH, 70% STENOSED, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 5MM IN DIAMETER AND MODERATELY TORTUOUS. A 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED AND AN 8X40M PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD RX WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 0%. DURING THE INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO HEMORRHAGIC STROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 15026245

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death