BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1671434 · Received May 3, 2010

    Report

    Report Number
    9616099-2010-00323
    Event Type
    Death
    Date Received
    May 3, 2010
    Date of Event
    September 13, 2009
    Report Date
    April 8, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B) (4) STUDY INDICATED THAT APPROXIMATELY FOUR MONTHS POST LEFT CAROTID ARTERY STENTING WITH A PRECISE PRO RX, THE PATIENT DIED IN A NURSING HOME. THE CAUSE OF DEATH IS UNKNOWN. THE BASELINE REPORT INDICATED THAT THE PATIENT (MALE, (B) (6)) HAD AN (B) (6) SCORE OF 2. THE MEDICAL HISTORY CONSISTED OF HYPERLIPIDEMIA, DIABETES MELLITUS, MYOCARDIAL INFARCTION (MI), CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. ADDITIONAL HIGH-RISK CRITERIA WAS INDICATED AS BILATERAL ARTERY STENOSIS. THE INDEX REPORT INDICATED THAT THE PATIENT WAS ASYMPTOMATIC, AND THE LESION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (L6) WITH A REFERENCE DIAMETER OF 5CM. THE STENOSIS WAS 99%, WITH A LENGTH OF 25CM, MILDLY CALCIFIED, NO DISSECTION WAS DOCUMENTED, AND WITHOUT TORTUOSITY. THE ARCH TYPE WAS III. IT WAS INDICATED THAT THE REVASCULARIZATION WAS PLANNED AND THERE WAS NO OCCLUSION OF THE CONTRALATERAL CAROTID. AN ANGIOGUARD WAS PLACED, AND THE LESION WAS PREDILATED. THEN, A PRECISEPRO RX STENT (PC0830RXC) WAS DEPLOYED AT THE TARGET SITE. THE SITE WAS NOT RESISTANT TO (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. POST-PROCEDURE THE STENOSIS WAS 20%. THERE NO STENT MALFUNCTIONS OR ASSOCIATED MAJOR ADVERSE EVENTS. THE ANGIOGUARD WAS SUCCESSFULLY DEPLOYED AND REMOVED WITH DEBRIS, AND THERE WERE NOT TECHNICAL PROBLEMS OR MAJOR ADVERSE EVENTS. THE PATIENT DID NOT REQUIRE EMERGENT CAROTID SURGERY. ECG WAS NOT CONDUCTED AFTER THE PROCEDURE. THE DISCHARGED REPORT INDICATED THE (B) (6)/STROKE SCALE WAS 2. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE PRE/POST AND DISCHARGED MEDICATIONS CONSISTED OF CLOPIDOGREL AND ASPIRIN. THE THIRTY DAY FOLLOW UP REPORT INDICATED THAT THE (B) (6)/STROKE SCALE WAS 2, WITH CONTINUATION OF DISCHARGED MEDICATIONS. NO MAJOR ADVERSE EVENTS WERE NOTED. APPROXIMATELY A MONTH AND HALF AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT ANOTHER PROCEDURE; TREATMENT OF THE OSTIUM OF THE RIGHT INTERNAL CAROTID (R6). AN ULTRASOUND FOUND THAT THE LESION WAS 90% STENOTIC, NO ADJACENT THROMBUS, MILD TORTUOSITY AND CALCIFICATION. THE LESION LENGTH WAS 20 AND THE STENTED SEGMENT WAS 40CM. THE REFERENCE VESSEL DIAMETER WAS 5CM. THE LESION WAS PREDILATED. THEN NON-CORDIS DEVICE (ABBOTT VASCULAR) STENT WAS IMPLANTED WITH USE OF A NONCORDIS ABBOTT EMBOLIC PROTECTION DEVICE. AFTER THE STENT IMPLANT, THERE WAS 10% RESIDUAL STENOSIS. THE PRECISE STENT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13440995 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MANUFACTURING RECORDS FOR LOT 13440995 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO NITINOL DEVICES & COMPONENTS (NDC), FOR PART NUMBER: 13440995 AND STENT LOT NUMBERS 117545, 117696; AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THE PATIENT¿S SIGNIFICANT MEDICAL HISTORY INCLUDING PRE-EXISTING CORONARY ARTERY DISEASE AND MI, DIABETES, AND TREATMENT OF CONTRALATERAL CAROTID STENOSIS ARE FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE BASELINE REPORT INDICATED THAT THE PATIENT (B) (6) WAS HAD A NIH SCORE OF 2. THE MEDICAL HISTORY CONSISTED OF HYPERLIPIDEMIA, DIABETES MELLITUS, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. THE INDEX REPORT INDICATED THAT THE PATIENT WAS ASYMPTOMATIC, AND THE LESION WAS THE (L6) OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY WITH A REFERENCE DIAMETER OF 5CM. THE STENOSIS WAS 99%, WITH A LENGTH OF 25CM, MILDLY CALCIFIED, NO DISSECTION WAS DOCUMENTED, AND WITHOUT TORTUOSITY. THE ARCH TYPE WAS III. REVASCULARIZATION WAS PLANNED AND THERE WAS NO OCCLUSION OF THE CONTRALATERAL CAROTID. AN ANGIOGUARD WAS PLACED, AND THE LESION WAS PREDILATED. THEN, A PRECISEPRO RX STENT (PC0830RXC) WAS DEPLOYED AT THE TARGET SITE. THE SITE WAS NOT RESISTANT TO (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. POST-PROCEDURE, THE STENOSIS WAS 20%. THERE NO STENT MALFUNCTIONS OF ASSOCIATED MAJOR ADVERSE EVENTS. THE ANGIOGUARD WAS SUCCESSFULLY DEPLOYED AND REMOVED WITH DEBRIS, AND THERE WERE NOT TECHNICAL PROBLEMS OR MAJOR ADVERSE EVENTS. THE PATIENT DID NOT REQUIRE EMERGENT CAROTID SURGERY. ECG WAS NOT CONDUCTED AFTER THE PROCEDURE. THE MAXIMUM TOTAL CK WAS 188, AND MAXIMUM UPPER LIMIT CK WAS 232. THE MAXIMUM CK-MB WAS 4.87 AND MAXIMUM UPPER LIMIT WAS 4 (NG/ML) THE DISCHARGED REPORT INDICATED THE (B) (6)/STROKE SCALE WAS 2. THE PRE/POST AND DISCHARGED MEDICATIONS CONSISTED OF CLOPIDOGREL AND ASPIRIN. THE 30 DAYS REPORT INDICATED THAT THE (B) (6)/STROKE SCALE WAS 2, AND THE PATIENT CONTINUES OF DISCHARGED MEDICATION. NO MAJOR ADVERSE EVENTS WERE NOTED. APPROXIMATELY A MONTH AND HALF AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT ANOTHER PROCEDURE OF THE (R6) OSTIUM OF THE RIGHT INTERNAL CAROTID. AN ULTRASOUND FOUND THAT THE LESION WAS 90% STENOTIC, NO ADJACENT THROMBUS, MILD TORTUOSITY AND CALCIFICATION. THE LESION LENGTH WAS 20 AND THE STENTED SEGMENT WAS 40CM. THE REFERENCE VESSEL DIAMETER WAS 5CM. THE LESION WAS PREDILATED. THEN NON-CORDIS DEVICE (ABBOTT VASCULAR) WAS IMPLANTED. AFTER THE STENT IMPLANT, THERE WAS 10% RESIDUAL STENOSIS. ADDITIONAL INFORMATION WIL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR (B)(6) STUDY INDICATED THAT UPON RETRIEVAL OF A 7MM MEDIUM SUPPORT ANGIOGUARD RX EMBOLIC PROTECTION DEVICE, THE FILTER BASKET MATERIAL WAS TORN ON ONE PART OF THE BASKET. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME. THE DEVICE WAS DEPLOYED AND WAS BEING RETRIEVED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF THE INTERVENTION. PTA WAS PERFORMED ON A 70% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID OF 30MM IN LENGTH IN A 5.0MM VESSEL DIAMETER. THE ARCH I TYPE LESION HAD MILD VESSEL TORTUOUSITY. THE ANGIOGUARD WAS DEPLOYED AFTER WHICH AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE RESIDUAL DIAMETER STENOSIS WAS 0%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE.

    Description of Event or Problem · 1

    THE (B) (4) STUDY INDICATED THAT APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT DIED IN THE NURSING HOME. THE CAUSE OF DEATH WAS UNKNOWN.

    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 13440995

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death