SMART CONTROL NITINOL STENT SYSTEM
Report
- Report Number
- 9616099-2012-00128
- Event Type
- Death
- Date Received
- February 29, 2012
- Date of Event
- September 1, 2002
- Report Date
- February 2, 2012
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K021898
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
TWO WEEKS LATER, THE PATIENT WAS READMITTED WITH GENERALIZED MALAISE AND MULTIPLE ERYTHEMATOUS, MACULAR LESIONS ON THE RIGHT FOREARM AND HAND. BLOOD CULTURES GREW STAPHYLOCOCCUS AUREUS, AND A COMPUTED TOMOGRAPHIC SCAN OF THE CHEST SHOWED A LARGE BRACHIOCEPHALIC ARTERY PSEUDOANEURYSM WITH SURROUNDING HEMATOMA. DESPITE PROMPT SURGICAL INTERVENTION, THIS COMPLICATION PROVED ULTIMATELY FATAL. PHYSICAL EXAMINATION SHOWED PETECHIAE CONSISTENT WITH SEPTIC EMBOLI THROUGHOUT THE PALM OF THE RIGHT HAND AND FOREARM, WHICH WERE SWOLLEN AND INFLAMED. THE INFECTIOUS DISEASE CONSULTANT RECOMMENDED INTRAVENOUS NAFCILLIN SODIUM THERAPY AFTER SENSITIVITIES WERE CONFIRMED. THE CONDITION OF THE HAND IMPROVED RAPIDLY ON ANTIBIOTICS, BUT THE BLOOD CULTURES REMAINED POSITIVE FOR S AUREUS AND IT WAS RECOMMENDED THAT THE PATIENT REMAIN ON INTRAVENOUS NAFCILLIN SODIUM THERAPY FOR 6 WEEKS. AT THE TIME OF ADMISSION, THE PATIENT HAD ALSO HAD SUDDEN, PERSISTENT LOSS OF VISION IN THE RIGHT EYE. EXAMINATION WITH NEUROOPHTHALMOLOGY DETECTED ROTH'S SPOTS IN THE RIGHT EYE; MAGNETIC RESONANCE IMAGING/ANGIOGRAPHY OF THE BRAIN SHOWED A PUNCTATE FOCUS OF INCREASED SIGNAL INTENSITY WITHIN THE RIGHT CORONA RADIATA, CONSISTENT WITH AN ACUTE SMALL VESSEL INFARCT. A COMPUTED TOMOGRAPHIC (CT) ANGIOGRAM SHOWED A 60% STENOSIS OF THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY, 70% STENOSIS OF THE LEFT INTERNAL CAROTID ARTERY AT THE BIFURCATION, AND 50% STENOSIS OF THE LEFT VERTEBRAL ARTERY AT THE ORIGIN. A THROMBUS WAS VISUALIZED BETWEEN THE TANDEM STENTS IN THE RIGHT SUBCLAVIAN ARTERY, FOR WHICH THE PATIENT UNDERWENT SYSTEMIC ANTICOAGULATION THERAPY WITH HEPARIN. CAROTID DUPLEX SCAN SHOWED SIGNIFICANT PLAQUES IN THE LEFT AND RIGHT DISTAL COMMON CAROTID ARTERIES EXTENDING INTO THE INTERNAL CAROTID ARTERIES, WITH VELOCITIES CORRESPONDING TO 80% TO 99% STENOSES BILATERALLY. ALTHOUGH THOUGHT INDICATED, CAROTID ENDARTERECTOMY WAS DEFERRED UNTIL THE INFECTION CLEARED. AFTER FURTHER WORK-UP FOR OTHER SOURCES OF SEPTIC EMBOLI INCLUDING ECHOCARDIOGRAPHY, IT WAS ULTIMATELY DECIDED THAT THE VISUAL SYMPTOMS WERE CAUSED BY SEPTIC EMBOLIZATION FROM THE BRACHIOCEPHALIC STENT TO THE BRAIN AND RIGHT EYE, IN ADDITION TO THOSE TO THE RIGHT HAND. THE PATIENT WAS DISCHARGED ON INTRAVENOUS ANTIBIOTICS AND ANTICOAGULATION THERAPY TO A REHABILITATION FACILITY. THE PATIENT WAS READMITTED 1 DAY LATER AFTER A 10-POINT FALL IN HEMATOCRIT AND AFTER STOOLS WERE REPORTEDLY POSITIVE FOR OCCULT BLOOD IN THE REHABILITATION FACILITY, WHICH WAS NOT DUPLICATED ON ADMISSION. WHILE THE PATIENT WAS UNDERGOING AN ANEMIA WORK-UP, PROGRESSIVELY WORSENING STRIDOR DEVELOPED. A CHEST RADIOGRAPH SHOWED TRACHEAL DEVIATION TO THE LEFT, AND FIBEROPTIC DIRECT LARYNGOSCOPY SHOWED A PARALYZED VOCAL CORD. CT SCAN OF THE NECK AND CHEST REVEALED A LARGE, ILL-DEFINED HOMOGENEOUS MASS MEASURING 5 3 CM ADJACENT TO THE RIGHT BRACHIOCEPHALIC ARTERY STENT DESCENDING INTO THE ANTERIOR MEDIASTINUM CONSISTENT WITH A MYCOTIC ANEURYSM WITH SURROUNDING HEMATOMA (FIG 2). IMMEDIATE OPERATIVE REMOVAL OF THE INFECTED STENT WITH RECONSTRUCTION WAS UNDERTAKEN. DURING AN APPROXIMATELY 12-HOUR PROCEDURE IN WHICH THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND COOLED TO APPROXIMATELY 18° C, THE INFECTED, ANEURYSMAL AREA OF THE BRACHIOCEPHALIC AT ITS ORIGIN FROM THE AORTA WAS LOCATED. A HOLE 3 CM IN DIAMETER WAS PRESENT, THROUGH WHICH THE FREE-FLOATING STENT WAS EASILY REMOVED (FIG 3). DESPITE EFFORTS AT RECONSTRUCTION WITH MAINTENANCE OF ADEQUATE CEREBRAL PERFUSION, THE PATIENT BECAME DIFFICULT TO VENTILATE AFTER RECEIVING MASSIVE AMOUNTS OF BLOOD AND BLOOD PRODUCTS. THE TISSUES BECAME MARKEDLY EDEMATOUS, MAKING CHEST CLOSURE IMPOSSIBLE. ACUTE RIGHT HEART FAILURE SUBSEQUENTLY DEVELOPED, AND THE PATIENT DIED IN THE OPERATING ROOM. PLEASE NOTE THAT THIS FILE REPRESENTS TWO (2) EACH PRODUCTS WITH UNKNOWN CATALOG AND LOT NUMBERS. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #9616099-2012-00128, AND #9616099-2012-00129.
COMPLAINT CONCLUSION: A LITERATURE SEARCH PRODUCED THE FOLLOWING ARTICLE: PRUITT ET AL IN DISTAL SEPTIC EMBOLI AND FATAL BRACHIOCEPHALIC ARTERY MYCOTIC PSEUDOANEURYSM AS A COMPLICATION OF STENTING; J VASC SURG. 2002 SEP;36(3):625-8. THE REPORT INDICATED THAT A FEMALE PATIENT WHO UNDERWENT SUBCLAVIAN AND BRACHIOCEPHALIC ARTERY ANGIOPLASTY AND STENT PLACEMENT FOR SYMPTOMATIC STENOSES. MEDICAL HISTORY WAS NOTABLE FOR A 50 PACK-YEAR HISTORY OF SMOKING BUT NO KNOWN PRIOR HISTORY OF PERIPHERAL VASCULAR DISEASE. ON PHYSICAL EXAMINATION, THE PATIENT WAS FOUND TO HAVE A MUMMIFIED RIGHT INDEX FINGER WITH ONLY A WEAKLY AUDIBLE RIGHT RADIAL ARTERY DOPPLER SIGNAL. ARTERIOGRAPHY SHOWED A 75% STENOSIS OF THE PROXIMAL RIGHT SUBCLAVIAN ARTERY, WITH A 30% STENOSIS MORE DISTALLY. IN ADDITION, A 65% STENOSIS WAS NOTED IN THE BRACHIOCEPHALIC ARTERY AT ITS ORIGIN FROM THE AORTIC ARCH, AND THE RIGHT RADIAL ARTERY WAS OCCLUDED. TANDEM 10 X 40 MM SMART STENTS WERE PLACED SUCCESSFULLY VIA THE LEFT FEMORAL ARTERY INTO THE SUBCLAVIAN STENOSES, AND A PALMAZ 294 STENT WAS PLACED INTO THE BRACHIOCEPHALIC ARTERY AT ITS ORIGIN. COMPLETION ARTERIOGRAPHY CONFIRMED OPTIMAL POSITIONING OF THE STENTS WITH RESTORATION OF BLOOD FLOW. THE PATIENT UNDERWENT AMPUTATION OF THE DISTAL PHALANX OF THE RIGHT INDEX FINGER 2 DAYS LATER. THE PATIENT RECOVERED PROMPTLY AND WAS DISCHARGED HOME IN STABLE CONDITION ON CLOPIDOGREL BISULFATE AND ASPIRIN THERAPY WITH A STRONG RECOMMENDATION TO DISCONTINUE SMOKING. TWO WEEKS LATER, THE PATIENT WAS READMITTED WITH GENERALIZED MALAISE AND MULTIPLE ERYTHEMATOUS, MACULAR LESIONS ON THE RIGHT FOREARM AND HAND. BLOOD CULTURES GREW STAPHYLOCOCCUS AUREUS, AND A COMPUTED TOMOGRAPHIC SCAN OF THE CHEST SHOWED A LARGE BRACHIOCEPHALIC ARTERY PSEUDOANEURYSM WITH SURROUNDING HEMATOMA. DESPITE PROMPT SURGICAL INTERVENTION, THIS COMPLICATION PROVED ULTIMATELY FATAL. PHYSICAL EXAMINATION SHOWED PETECHIAE CONSISTENT WITH SEPTIC EMBOLI THROUGHOUT THE PALM OF THE RIGHT HAND AND FOREARM, WHICH WERE SWOLLEN AND INFLAMED. THE INFECTIOUS DISEASE CONSULTANT RECOMMENDED INTRAVENOUS NAFCILLIN SODIUM THERAPY AFTER SENSITIVITIES WERE CONFIRMED. THE CONDITION OF THE HAND IMPROVED RAPIDLY ON ANTIBIOTICS, BUT THE BLOOD CULTURES REMAINED POSITIVE FOR S AUREUS AND IT WAS RECOMMENDED THAT THE PATIENT REMAIN ON INTRAVENOUS NAFCILLIN SODIUM THERAPY FOR 6 WEEKS. AT THE TIME OF ADMISSION, THE PATIENT HAD ALSO HAD SUDDEN, PERSISTENT LOSS OF VISION IN THE RIGHT EYE. EXAMINATION WITH NEUROOPHTHALMOLOGY DETECTED ROTH'S SPOTS IN THE RIGHT EYE; MAGNETIC RESONANCE IMAGING/ANGIOGRAPHY OF THE BRAIN SHOWED A PUNCTATE FOCUS OF INCREASED SIGNAL INTENSITY WITHIN THE RIGHT CORONA RADIATA, CONSISTENT WITH AN ACUTE SMALL VESSEL INFARCT. A COMPUTED TOMOGRAPHIC (CT) ANGIOGRAM SHOWED A 60% STENOSIS OF THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY, 70% STENOSIS OF THE LEFT INTERNAL CAROTID ARTERY AT THE BIFURCATION, AND 50% STENOSIS OF THE LEFT VERTEBRAL ARTERY AT THE ORIGIN. A THROMBUS WAS VISUALIZED BETWEEN THE TANDEM STENTS IN THE RIGHT SUBCLAVIAN ARTERY, FOR WHICH THE PATIENT UNDERWENT SYSTEMIC ANTICOAGULATION THERAPY WITH HEPARIN. CAROTID DUPLEX SCAN SHOWED SIGNIFICANT PLAQUES IN THE LEFT AND RIGHT DISTAL COMMON CAROTID ARTERIES EXTENDING INTO THE INTERNAL CAROTID ARTERIES, WITH VELOCITIES CORRESPONDING TO 80% TO 99% STENOSES BILATERALLY. ALTHOUGH THOUGHT INDICATED, CAROTID ENDARTERECTOMY WAS DEFERRED UNTIL THE INFECTION CLEARED. AFTER FURTHER WORK-UP FOR OTHER SOURCES OF SEPTIC EMBOLI INCLUDING ECHOCARDIOGRAPHY, IT WAS ULTIMATELY DECIDED THAT THE VISUAL SYMPTOMS WERE CAUSED BY SEPTIC EMBOLIZATION FROM THE BRACHIOCEPHALIC STENT TO THE BRAIN AND RIGHT EYE, IN ADDITION TO THOSE TO THE RIGHT HAND. THE PATIENT WAS DISCHARGED ON INTRAVENOUS ANTIBIOTICS AND ANTICOAGULATION THERAPY TO A REHABILITATION FACILITY. THE PATIENT WAS READMITTED 1 DAY LATER AFTER A 10-POINT FALL IN HEMATOCRIT AND AFTER STOOLS WERE REPORTEDLY POSITIVE FOR OCCULT BLOOD IN THE REHABILITATION FACILITY, WHICH WAS NOT DUPLICATED ON ADMISSION. WHILE THE PATIENT WAS UNDERGOING AN ANEMIA WORK-UP, PROGRESSIVELY WORSENING STRIDOR DEVELOPED. A CHEST RADIOGRAPH SHOWED TRACHEAL DEVIATION TO THE LEFT, AND FIBER OPTIC DIRECT LARYNGOSCOPY SHOWED A PARALYZED VOCAL CORD. CT SCAN OF THE NECK AND CHEST REVEALED A LARGE, ILL-DEFINED HOMOGENEOUS MASS MEASURING 5 - 3 CM ADJACENT TO THE RIGHT BRACHIOCEPHALIC ARTERY STENT DESCENDING INTO THE ANTERIOR MEDIASTINUM CONSISTENT WITH A MYCOTIC ANEURYSM WITH SURROUNDING HEMATOMA. IMMEDIATE OPERATIVE REMOVAL OF THE INFECTED STENT WITH RECONSTRUCTION WAS UNDERTAKEN. DURING AN APPROXIMATELY 12-HOUR PROCEDURE, IN WHICH THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND COOLED TO APPROXIMATELY 18 DEGREES C, THE INFECTED, ANEURYSMAL AREA OF THE BRACHIOCEPHALIC AT ITS ORIGIN FROM THE AORTA WAS LOCATED. A HOLE 3 CM IN DIAMETER WAS PRESENT, THROUGH WHICH THE FREE-FLOATING STENT WAS EASILY REMOVED. DESPITE EFFORTS AT RECONSTRUCTION WITH MAINTENANCE OF ADEQUATE CEREBRAL PERFUSION, THE PATIENT BECAME DIFFICULT TO VENTILATE AFTER RECEIVING MASSIVE AMOUNTS OF BLOOD AND BLOOD PRODUCTS. THE TISSUES BECAME MARKEDLY EDEMATOUS, MAKING CHEST CLOSURE IMPOSSIBLE. ACUTE RIGHT HEART FAILURE SUBSEQUENTLY DEVELOPED, AND THE PATIENT DIED IN THE OPERATING ROOM. (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. IT IS UNKNOWN AT WHAT POINT AND HOW THE PATIENT WAS EXPOSED TO A BACTERIAL PATHOGEN. 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, HOWEVER, AT THIS TIME, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. 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 FEMORAL ARTERY ANEURYSMS, IN GENERAL, THEY ARE CAUSED BY LIFESTYLE FACTORS. OTHER SPECIFIC CAUSES OF ANEURYSMS ARE RELATED TO THE LOCATION OF THE ANEURYSM. AN OPENING IN THE ARTERY LEADS TO LEAKAGE OF BLOOD FROM THE ARTERY (A "HEMATOMA"). THIS HEMATOMA DEVELOPS A WALL AROUND IT AND THE HEMATOMA LIQUEFIES AND FORMS A PULSATING "BUBBLE" ON THE ARTERY. THIS IS CALLED A PSEUDOANEURYSM. A PSEUDOANEURYSM, LIKE ANY ANEURYSM, CAN RUPTURE AND CAUSE BLEEDING OR LOSS OF LIMB. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. 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. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THE FREE FLOATING STENT MAY HAVE BEEN THE RESULT OF THE ANEURYSM FORMATION AROUND THE STENT RESULTING IN LOSS OF WALL APPOSITION. THIS DOES NOT REPRESENT A DEVICE FAILURE. FACTORS THAT MAY HAVE INFLUENCED THESE EVENTS INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #9616099-2012-00128, AND #9616099-2012-00129.
A LITERATURE SEARCH PRODUCED THE FOLLOWING ARTICLE: PRUITT ET AL IN DISTAL SEPTIC EMBOLI AND FATAL BRACHIOCEPHALIC ARTERY MYCOTIC PSEUDOANEURYSM AS A COMPLICATION OF STENTING; J VASC SURG. 2002 SEP;36(3):625-8. THE REPORT INDICATED THAT A FEMALE PATIENT WHO UNDERWENT SUBCLAVIAN AND BRACHIOCEPHALIC ARTERY ANGIOPLASTY AND STENT PLACEMENT FOR SYMPTOMATIC STENOSES. MEDICAL HISTORY WAS NOTABLE FOR A 50 PACK-YEAR HISTORY OF SMOKING BUT NO KNOWN PRIOR HISTORY OF PERIPHERAL VASCULAR DISEASE. ON PHYSICAL EXAMINATION, THE PATIENT WAS FOUND TO HAVE A MUMMIFIED RIGHT INDEX FINGER WITH ONLY A WEAKLY AUDIBLE RIGHT RADIAL ARTERY DOPPLER SIGNAL. ARTERIOGRAPHY SHOWED A 75% STENOSIS OF THE PROXIMAL RIGHT SUBCLAVIAN ARTERY, WITH A 30% STENOSIS MORE DISTALLY. IN ADDITION, A 65% STENOSIS WAS NOTED IN THE BRACHIOCEPHALIC ARTERY AT ITS ORIGIN FROM THE AORTIC ARCH, AND THE RIGHT RADIAL ARTERY WAS OCCLUDED. TANDEM 10 X 40 MM SMART STENTS WERE PLACED SUCCESSFULLY VIA THE LEFT FEMORAL ARTERY INTO THE SUBCLAVIAN STENOSES, AND A PALMAZ 294 STENT WAS PLACED INTO THE BRACHIOCEPHALIC ARTERY AT ITS ORIGIN. COMPLETION ARTERIOGRAPHY CONFIRMED OPTIMAL POSITIONING OF THE STENTS WITH RESTORATION OF BLOOD FLOW. THE PATIENT UNDERWENT AMPUTATION OF THE DISTAL PHALANX OF THE RIGHT INDEX FINGER 2 DAYS LATER. THE PATIENT RECOVERED PROMPTLY AND WAS DISCHARGED HOME IN STABLE CONDITION ON CLOPIDOGREL BISULFATE AND ASPIRIN THERAPY WITH A STRONG RECOMMENDATION TO DISCONTINUE SMOKING. SIX MONTHS AFTER THE INITIAL INTERVENTION, THE PATIENT RETURNED WITH RESTENOSIS OF THE STENTS AND UNDERWENT REPEAT ANGIOPLASTY TO RESTORE FULL PATENCY. OF NOTE, NO ANTIBIOTICS WERE USED DURING EITHER ANGIOGRAPHIC PROCEDURE, WHICH IS STANDARD PROTOCOL FOR STENT PLACEMENT AT OUR INSTITUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS | FGE | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death| H| L| R |