BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 2468983 · Received February 27, 2012

    Report

    Report Number
    9616099-2012-00120
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    April 1, 2002
    Report Date
    April 5, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BEGUN ON INTRAVENOUS HEPARIN. COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN AND PELVIS SHOWED INFLAMMATION IN THE RETROPERITONEAL AREA NEAR THE RIGHT ILIAC ARTERY STENT; THERE WAS ALSO LEFT ILIAC VEIN THROMBOSIS EXTENDING INTO THE INFERIOR VENA CAVA (IVC). ON ADMISSION TO OUR HOSPITAL, HIS TEMPERATURE WAS 38.3°C, AND HIS LEFT LEG WAS EDEMATOUS. HE HAD RIGHT LOWER QUADRANT TENDERNESS, NO PALPABLE MASS, AND A WHITE BLOOD CELL (WBC) COUNT OF 18.0 × 109/L WITH 18% BANDS. INTRAVENOUS VANCOMYCIN WAS STARTED. A TECHNETIUM TC 99M LABELED (632.7 MBQ) WBC SCAN WAS NEGATIVE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED NO VEGETATIONS ON THE VALVES. HIS TEMPERATURE RETURNED TO NORMAL ON THE THIRD DAY OF ANTIBIOTIC TREATMENT. HIS WBC ALSO DECREASED TO 11.4 × 109/L WITH NORMAL BANDS. ON HOSPITAL DAY 10, HE DEVELOPED ABDOMINAL DISTENSION, AND A REPEAT CT SCAN NOW SHOWED AN ANEURYSM WITH MARKED INFLAMMATION IN THE RIGHT ILIAC ARTERY AND ASSOCIATED SMALL BOWEL OBSTRUCTION. AFTER AN IVC FILTER WAS PLACED, AXILLOBIFEMORAL BYPASS WAS PERFORMED BECAUSE OF THE PROXIMITY OF THE MYCOTIC ANEURYSM TO THE AORTIC BIFURCATION. DURING LAPAROTOMY, TORRENTIAL BLEEDING ENSUED WHEN THE SMALL BOWEL ADHERENT TO THE INFLAMED AREA WAS BEING FREED; THE DISTAL AORTA, LEFT CIA, AS WELL AS THE RIGHT INTERNAL AND EXTERNAL ILIAC ARTERIES, WERE OVERSEWN. AFTER DEBRIDEMENT OF THE INFLAMED TISSUES AND REMOVAL OF THE STENTS, THE PART OF THE SMALL BOWEL DAMAGED BY INFLAMMATION AND DISSECTION HAD TO BE RESECTED. INTRAOPERATIVE BLOOD LOSS WAS 8 L. MICROSCOPIC EXAMINATION OF THE DEBRIDED ARTERIAL TISSUE SHOWED ABSCESS FORMATION WITH NECROSIS. THE CULTURE OBTAINED FROM THE MYCOTIC ANEURYSM GREW (B)(6). THE PATIENT'S PROLONGED POSTOPERATIVE COURSE WAS COMPLICATED BY RESPIRATORY FAILURE REQUIRING TRACHEOSTOMY. HE RECOVERED AND WAS DISCHARGED ON HOSPITAL DAY 32. AT THE 18-MONTH FOLLOW-UP, HE WAS ALIVE AND WELL. JOURNAL ARTICLE INFORMATION: DOSLUOGLU, H. HALDUN. (2001). STENT-RELATED ILIAC ARTERY AND ILIAC VEIN INFECTIONS: TWO UNREPORTED PRESENTATIONS AND REVIEW OF THE LITERATURE. J ENDOVASC THER 2001;8:202-209 THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2012-00121. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2012-00121. DOSLUOGLU ET AL IN STENT-RELATED ILIAC ARTERY AND ILIAC VEIN INFECTIONS: TWO UNREPORTED PRESENTATIONS AND REVIEW OF THE LITERATURE; J ENDOVASC THER. 2001 APR;8(2):202-9. REPORT ON A CASE WHICH INVOLVED AN ILIAC ARTERY STENT INFECTION SECONDARY TO A REMOTE BACTEREMIA 6 MONTHS AFTER STENT PLACEMENT. IT WAS DIAGNOSED BY USE OF COMPUTED TOMOGRAPHY AND WAS TREATED SURGICALLY AFTER MEDICAL MANAGEMENT FAILED. A (B)(6) MAN WITH A HISTORY OF CORONARY ARTERY DISEASE AND DIABETES WAS DIAGNOSED WITH A 70% RIGHT ILIAC STENOSIS AFTER EVALUATION FOR DISABLING CLAUDICATION. HE UNDERWENT ANGIOPLASTY AND STENTING IN THE ANGIOGRAPHY SUITE; A 20- × 8-MM PALMAZ STENT WAS DEPLOYED IN THE ILIAC ARTERY. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. HE RETURNED 1 YEAR LATER WITH INCREASING CLAUDICATION IN THE RIGHT LEG; REPEAT ANGIOGRAPHY SHOWED A 50% RIGHT COMMON ILIAC ARTERY (CIA) STENOSIS DISTAL TO THE STENT. THE LESION WAS DILATED AND A SECOND PALMAZ STENT IMPLANTED WITH EXCELLENT RESULTS. FIVE MONTHS LATER, HE WAS DIAGNOSED WITH GASTRIC CANCER AND UNDERWENT RADICAL SUBTOTAL GASTRECTOMY WITH JEJUNOSTOMY TUBE PLACEMENT. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY PROLONGED ILEUS NECESSITATING HYPERALIMENTATION VIA A SUBCLAVIAN CATHETER. ON POSTOPERATIVE DAY 16, HE DEVELOPED CENTRAL CATHETER (B)(6) SEPTICEMIA, WHICH WAS TREATED BY LINE REMOVAL AND INTRAVENOUS VANCOMYCIN FOR 7 DAYS. HIS SEPSIS RESOLVED, AND HE WAS DISCHARGED 23 DAYS AFTER ADMISSION. FIVE WEEKS THEREAFTER, THE PATIENT PRESENTED TO A LOCAL HOSPITAL WITH RIGHT LOWER ABDOMINAL PAIN, RIGHT HIP PAIN, MALAISE, FEVER, AND LEFT LEG SWELLING. A DUPLEX SCAN SHOWED LEFT ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT), AND HIS BLOOD CULTURES GREW (B)(6). THE PATIENT WAS BEGUN ON INTRAVENOUS HEPARIN. COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN AND PELVIS SHOWED INFLAMMATION IN THE RETROPERITONEAL AREA NEAR THE RIGHT ILIAC ARTERY STENT; THERE WAS ALSO LEFT ILIAC VEIN THROMBOSIS EXTENDING INTO THE INFERIOR VENA CAVA (IVC). ON ADMISSION TO OUR HOSPITAL, HIS TEMPERATURE WAS 38.3 DEGREES C, AND HIS LEFT LEG WAS EDEMATOUS. HE HAD RIGHT LOWER QUADRANT TENDERNESS, NO PALPABLE MASS, AND A WHITE BLOOD CELL (WBC) COUNT OF 18.0 × 109/L WITH 18% BANDS. INTRAVENOUS VANCOMYCIN WAS STARTED. A TECHNETIUM TC 99M LABELED (632.7 MBQ) WBC SCAN WAS NEGATIVE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED NO VEGETATIONS ON THE VALVES. HIS TEMPERATURE RETURNED TO NORMAL ON THE THIRD DAY OF ANTIBIOTIC TREATMENT. HIS WBC ALSO DECREASED TO 11.4 × 109/L WITH NORMAL BANDS. ON HOSPITAL DAY 10, HE DEVELOPED ABDOMINAL DISTENSION, AND A REPEAT CT SCAN NOW SHOWED AN ANEURYSM WITH MARKED INFLAMMATION IN THE RIGHT ILIAC ARTERY AND ASSOCIATED SMALL BOWEL OBSTRUCTION. AFTER AN IVC FILTER WAS PLACED, AXILLOBIFEMORAL BYPASS WAS PERFORMED BECAUSE OF THE PROXIMITY OF THE MYCOTIC ANEURYSM TO THE AORTIC BIFURCATION. DURING LAPAROTOMY, TORRENTIAL BLEEDING ENSUED WHEN THE SMALL BOWEL ADHERENT TO THE INFLAMED AREA WAS BEING FREED; THE DISTAL AORTA, LEFT CIA, AS WELL AS THE RIGHT INTERNAL AND EXTERNAL ILIAC ARTERIES, WERE OVERSEWN. AFTER DEBRIDEMENT OF THE INFLAMED TISSUES AND REMOVAL OF THE STENTS, THE PART OF THE SMALL BOWEL DAMAGED BY INFLAMMATION AND DISSECTION HAD TO BE RESECTED. INTRAOPERATIVE BLOOD LOSS WAS 8 L. MICROSCOPIC EXAMINATION OF THE DEBRIDED ARTERIAL TISSUE SHOWED ABSCESS FORMATION WITH NECROSIS. THE CULTURE OBTAINED FROM THE MYCOTIC ANEURYSM GREW (B)(6). THE PATIENT'S PROLONGED POSTOPERATIVE COURSE WAS COMPLICATED BY RESPIRATORY FAILURE REQUIRING TRACHEOSTOMY. HE RECOVERED AND WAS DISCHARGED ON HOSPITAL DAY 32. AT THE 18-MONTH FOLLOW-UP, HE WAS ALIVE AND WELL. (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. THERE WAS A 50% RIGHT COMMON ILIAC ARTERY (CIA) STENOSIS DISTAL TO THE STENT REPORTED. IT IS UNKNOWN HOW FAR FROM OR CLOSE TO THE STENT THE STENOSIS WAS. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. WELL DOCUMENTED POTENTIAL COMPLICATION OF STENT PLACEMENT IS SUBSEQUENT INTIMAL HYPERPLASIA AND OCCLUSION. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. INFECTIONS RESULTING FROM INVASIVE PROCEDURES ARE A WELL KNOWN POTENTIAL ADVERSE EVENT AND ARE LISTED IN THE IFU AS SUCH. THERE ARE A MULTITUDE OF POSSIBLE ETIOLOGIES AND OPPORTUNITIES FOR THE INTRODUCTION OF PATHOGENS INTO THE PATIENT. IN THIS CASE THE INFECTION PRESENTED OVER 5 MONTHS AFTER HAVING THE STENTS IMPLANTED AND ONLY 16 DAYS AFTER A SECONDARY INVASIVE PROCEDURE AND WAS LIKELY ASSOCIATED WITH THIS PROCEDURE. AN ANEURYSM IS A BULGING, WEAKENED AREA IN THE WALL OF A BLOOD VESSEL RESULTING IN AN ABNORMAL WIDENING OR BALLOONING GREATER THAN 50 PERCENT OF THE NORMAL DIAMETER (WIDTH). AN ANEURYSM MAY OCCUR IN ANY BLOOD VESSEL, BUT IS MOST OFTEN SEEN IN AN ARTERY RATHER THAN A VEIN. AN ANEURYSM MAY BE CAUSED BY MULTIPLE FACTORS THAT RESULT IN THE BREAKING DOWN OF THE WELL-ORGANIZED STRUCTURAL COMPONENTS (PROTEINS) OF THE AORTIC WALL THAT PROVIDE SUPPORT AND STABILIZE THE WALL. THE EXACT CAUSE IS NOT FULLY KNOWN. ATHEROSCLEROSIS (HARDENING OF THE ARTERIES) IS THOUGHT TO PLAY AN IMPORTANT ROLE IN ANEURYSMAL DISEASE ALTHOUGH THERE ARE RARE INSTANCES WHERE AN INFECTION OR AN INJURY CAUSES ILIAC ARTERY ANEURYSMS, IN GENERAL THEY ARE CAUSED BY LIFESTYLE FACTORS.

    Description of Event or Problem · 1

    DOSLUOGLU ET AL IN STENT-RELATED ILIAC ARTERY AND ILIAC VEIN INFECTIONS: TWO UNREPORTED PRESENTATIONS AND REVIEW OF THE LITERATURE; J ENDOVASC THER. 2001 APR;8(2):202-9; REPORT ON A CASE WHICH INVOLVED AN ILIAC ARTERY STENT INFECTION SECONDARY TO A REMOTE BACTEREMIA 6 MONTHS AFTER STENT PLACEMENT. IT WAS DIAGNOSED BY USE OF COMPUTED TOMOGRAPHY AND WAS TREATED SURGICALLY AFTER MEDICAL MANAGEMENT FAILED. A (B)(6) WITH A HISTORY OF CORONARY ARTERY DISEASE AND DIABETES WAS DIAGNOSED WITH A 70% RIGHT ILIAC STENOSIS AFTER EVALUATION FOR DISABLING CLAUDICATION. HE UNDERWENT ANGIOPLASTY AND STENTING IN THE ANGIOGRAPHY SUITE; A 20- × 8-MM PALMAZ STENT (CORDIS ENDOVASCULAR, (B)(4)) WAS DEPLOYED IN THE ILIAC ARTERY. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. HE RETURNED 1 YEAR LATER WITH INCREASING CLAUDICATION IN THE RIGHT LEG; REPEAT ANGIOGRAPHY SHOWED A 50% RIGHT COMMON ILIAC ARTERY (CIA) STENOSIS DISTAL TO THE STENT. THE LESION WAS DILATED AND A SECOND PALMAZ STENT IMPLANTED WITH EXCELLENT RESULTS. FIVE MONTHS LATER, HE WAS DIAGNOSED WITH GASTRIC CANCER AND UNDERWENT RADICAL SUBTOTAL GASTRECTOMY WITH JEJUNOSTOMY TUBE PLACEMENT. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY PROLONGED ILEUS NECESSITATING HYPERALIMENTATION VIA A SUBCLAVIAN CATHETER. ON POSTOPERATIVE DAY 16, HE DEVELOPED CENTRAL CATHETER (B)(6), WHICH WAS TREATED BY LINE REMOVAL AND INTRAVENOUS VANCOMYCIN FOR 7 DAYS. HIS SEPSIS RESOLVED, AND HE WAS DISCHARGED 23 DAYS AFTER ADMISSION. FIVE WEEKS THEREAFTER, THE PATIENT PRESENTED TO A LOCAL HOSPITAL WITH RIGHT LOWER ABDOMINAL PAIN, RIGHT HIP PAIN, MALAISE, FEVER, AND LEFT LEG SWELLING. A DUPLEX SCAN SHOWED LEFT ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT), AND HIS BLOOD CULTURES GREW (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention