BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2082206 · Received May 9, 2011

    Report

    Report Number
    9616099-2011-00313
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN COMMENTED THAT THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, AND WAS ALSO COMPLICATED BY ANGINA. THIS EVENT APPEARED IMMEDIATELY AFTER THE ANGIOPLASTY, AND THE CAUSE OF THE EVENT WAS CONSIDERED A CONTRAST MATERIAL AND/OR ISCHEMIA. HOWEVER, I JUDGED IT WAS IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE BECAUSE THIS EVENT OCCURRED AFTER THE PROCEDURE WITH THE STUDY DEVICE. CONCOMITANT MEDICATIONS: BAYASPIRIN, TICPLIONE, PLETAL, LASIX, ARTIST, ONEALFA, MICARDIS, VOGLIBOSE, SALMUMOSIN, LOXONIN, MUCOSTA, LIPITOR, NEUCHLONIC, HUSCODE, KAKKONTO AND PURSENNID. THIS DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR TESTING OR EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 2 WEEKS AFTER PTA AND STENT PLACEMENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY DOPPLER AND BLOOD FLOW VELOCITY WAS UNMEASURABLE. THE FOLLOWING DAY, AN ADDITIONAL STENT WAS PLACED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND THE FOLLOWING DAY THE PATIENT WAS DISCHARGED. INITIALLY THE PATIENT HAD BEEN ALLOCATED TO THE POBA GROUP, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED FOR PRE-DILATATION NON-CORDIS DEVICES. HOWEVER IT BECAME A BAILOUT PROCEDURE REQUIRING STENT PLACEMENT. AFTER THE PROCEDURE, SPO2 DECREASED TO 88% WAS NOTED AND SHE RECEIVED OXYGEN THERAPY VIA NASAL CANNULA (3L/MIN). SPO2 IMPROVED TO 98%. ON THE FOLLOWING DAY, LEFT VENTRICULAR DILATATION AND HEART WALL MOTION ABNORMALITY WERE NOTED BY ECHOCARDIOGRAPHY. THERAPY WAS STARTED BECAUSE OF SUSPECTED CARDIAC FAILURE. SHE WAS TREATED WITH BED REST, FLUID RESTRICTION, OXYGEN ADMINISTRATION, AND INTRAVENOUS MYOCOR AND SIGMART. ON THE FOLLOWING DAY, SPO2 MAINTAINED 98%. HOSPITALIZATION WAS PROLONGED BECAUSE OF CONTINUING TREATMENT WITH BED REST, FLUID RESTRICTION, OXYGEN ADMINISTRATION, AND INTRAVENOUS MYCOR AND SIGMART. THE PHYSICIAN COMMENTED THAT THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, AND WAS ALSO COMPLICATED BY ANGINA. THIS EVENT APPEARED IMMEDIATELY AFTER THE ANGIOPLASTY, AND THE CAUSE OF THE EVENT WAS CONSIDERED RELATED TO CONTRAST MATERIAL AND/OR ISCHEMIA. HOWEVER, THE PHYSICIAN JUDGED IT WAS IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE BECAUSE THIS EVENT OCCURRED AFTER THE PROCEDURE WITH THE STUDY DEVICE. THE PATIENT'S MEDICAL HISTORY INCLUDES CEREBRAL INFARCTION, CARDIAC FAILURE, CEREBRAL VASCULAR BYPASS SURGERY, PLACEMENT OF STENT IN THE ARTERY OF THE LOWER EXTREMITY, ARTERIOSCLEROTIC OBLITERATION (PRIMARY DISEASE), ANGINA, HYPERTENSION, HYPERLIPIDEMIA AND DIABETES MELLITUS. 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 15140215 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ALTHOUGH THERE IS NO MEDICAL INDICATION OF A CAUSAL RELATIONSHIP BETWEEN THE STUDY DEVICE AND THE EVENT, THE PHYSICIAN JUDGED IT WAS IMPOSSIBLE TO RULE OUT A CAUSAL RELATIONSHIP TO THE STUDY DEVICE AND THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT THIS PATIENT HAD ARTERIAL RESTENOSIS. HOWEVER, IT WAS FOUND THAT THIS INFORMATION WAS ADDED TO THIS FILE IN ERROR AS IT PERTAINS TO PATIENT (B)(4) COMPLAINT SR #(B)(4). THE RESTENOSIS EVENT WAS REPORTED UNDER SR (B)(4) UNDER MANUFACTURING REPORT NUMBER (B)(4). THEREFORE, NO FURTHER EVENTS WILL BE REPORTED REGARDING THIS EVENT FOR THE PATIENT UNDER REPORT NUMBER 9616099-2011-00313.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY 2 WEEKS AFTER PTA IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH A SMART CONTROL STENT, THE ABI WAS 0.74 ON THE RIGHT AND 1.06 ON THE LEFT. THE LOWER EXTREMITY ARTERIAL ECHO WAS PERFORMED. IT REVEALED THE TREATED SEGMENT WAS NOT DETECTABLE THROUGH THE STUDY STENT ON COLOR DOPPLER, AND BLOOD FLOW VELOCITY WAS UNMEASURABLE. ON THE FOLLOWING DAY, STENT PLACEMENT WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY. ON THE FOLLOWING DAY, THE ABI WAS 0.99 ON THE RIGHT AND 1.09 ON THE LEFT AND ON THE NEXT DAY, NO CLAUDICATION SYMPTOM WAS FOUND AND THE PATIENT WAS DISCHARGED IN RECOVERY CONDITION. AT STUDY ADMISSION, THE PATIENT WAS ADMITTED FOR TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE STUDY WAS EXPLAINED, AND HER CONSENT WAS OBTAINED. BASED ON THE ANGIOGRAPHY FINDINGS, THE PATIENT WAS JUDGED TO MEET THE STUDY CRITERIA. SHE WAS ALLOCATED TO THE POBA GROUP, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED FOR PRE-DILATATION WITH AMPHIRION DEEP/MEDTRONIC (B)(4); JACKAL OTW4.0-100/ST. JUDE MEDICAL (B)(4) AND POST- DILATATION WITH A JACKAL OTW4.0-100. HOWEVER IT BECAME A BAILOUT, AND A STUDY DEVICE WAS PLACED (DIAMETER 6 MM X LENGTH 100 MM). AFTER THE PROCEDURE, SPO2 DECREASED TO 88% WAS NOTED AND SHE RECEIVED OXYGEN THERAPY VIA NASAL CANNULA (3L/MIN). SPO2 IMPROVED TO 98%. ON THE FOLLOWING DAY, LEFT VENTRICULAR DILATATION AND HEART WALL MOTION ABNORMALITY WERE NOTED BY ECHOCARDIOGRAPHY. THERAPY WAS STARTED BECAUSE OF SUSPECTED CARDIAC FAILURE. SHE WAS TREATED WITH BED REST, FLUID RESTRICTION, OXYGEN ADMINISTRATION, AND INTRAVENOUS MYOCOR AND SIGMART. ON THE FOLLOWING DAY, SPO2 MAINTAINED 98%. HOSPITALIZATION WAS PROLONGED BECAUSE OF CONTINUING TREATMENT WITH BED REST, FLUID RESTRICTION, OXYGEN ADMINISTRATION, AND INTRAVENOUS MYCOR AND SIGMART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 15140215

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R