SMART CONTROL NITINOL STENT SYSTEM
Report
- Report Number
- 9616099-2011-00542
- Event Type
- Injury
- Date Received
- July 26, 2011
- Date of Event
- June 16, 2011
- Report Date
- July 6, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIO
- PMA / PMN Number
- P020036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2011, THE RESTENOSIS WAS NOTED IN THE STUDY STENT AT LEFT SUPERFICIAL FEMORAL ARTERY. HOWEVER, HE WAS NOT TREATED BECAUSE OF MILD CLAUDICATION AND THE ABI, 0.80. THE INR (INTERNATIONAL NORMALIZED RATIO) WAS MAINTAINED IN THE RANGE OF 2.5 TO 2.7 THUS FAR, HOWEVER, IT WAS 1.94 TODAY. ON (B)(6) 2011, WARFARIN TAB WAS DECREASED FROM 8 MG TO 3 MG AND PARAMIDIN CAPSULES 300 MG WAS STARTED. ON (B)(6) 2011, WARFARIN TAB WAS DECREASED TO 2 MG BECAUSE THE INR INCREASED TO 3.47. PARAMIDIN CAPSULES 300 MG WAS CONTINUED. ON (B)(6) 2012, THERE WAS A TELEPHONE FROM HIS FAMILY. ON (B)(6) 2011, HE WAS DISCOVERED IN UNCONSCIOUS STATE WITH VOMITUS, AND TRANSFERRED TO THE HOSPITAL. HE WAS DIAGNOSED AS CEREBRAL HAEMORRHAGE (THALAMUS HAEMORRHAGE), AND WAS CONFIRMED DEAD. ON 01/23/2012, A MEDICAL INFORMATION FORM WAS RECEIVED FROM THE HOSPITAL WHICH THE PATIENT WAS TAKEN TO. "WHEN THE PATIENT WAS TRANSFERRED, THE PATIENT'S CONSCIOUS LEVEL WAS "LLL - 200," AND HIS STATUS WAS BILATERAL DILATATION PUPILLARY AND WEAK RESPIRATORY. ALTHOUGH THE PATIENT WAS INTUBATED, WE COULD NOT TAKE ANY ACTION. ON THE SAME DAY, THE PATIENT WAS CONFIRMED DEAD." PHYSICIAN'S COMMENT FOR THIS EVENT: THIS EVENT WAS NOT RELATED TO THE TARGET LESION, AND A LONG TIME HAD PASSED SINCE THE INDEX PROCEDURE. THEREFORE, IT HAD BEEN JUDGED TO POSSIBLE TO RULE OUT A CAUSAL RELATION TO STUDY DEVICES AND INDEX PROCEDURE. IT COULD NOT DENY THAT AGGRAVATION OF THIS EVENT HAD BEEN INFLUENCED BY THE WARFARIN DOSAGE AFTER SAE STARTED IN (B)(6) 2011, ALTHOUGH WAS CONSIDERED THERE WAS NO DIRECT INFLUENCE ON OCCURRENCE OF THIS EVENT. THE PHYSICIAN'S JUDGMENTS WERE AS FOLLOWS FOR CEREBRAL HAEMORRHAGE: IT WAS JUDGED TO BE POSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. IT WAS JUDGED TO BE CAUSAL RELATION TO THE CONCOMITANT MEDICATION (WARFARIN). THIS IS ONE OF 4 DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 9616099-2011-00445, 9616099-2011-00445, 9616099-2011-00542 AND 9616099-2011-00543.
THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THIS PATIENT WAS FOUND TO HAVE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) STENOSIS AND WAS ALLOCATED TO THE POBA (ANGIOPLASTY) GROUP. ON (B)(6) 2010, PTA WITH SLEEK AND SAVVY LONG BALLOONS WAS PERFORMED, BUT BAILOUT STENTING WAS PERFORMED WITH TWO SMART CONTROLS, A 6X80MM (PROXIMAL) AND A 6X100MM (DISTAL) DUE TO INADEQUATE PTA RESULTS. FIVE AND 1/2 MONTHS LATER, THE PATIENT WAS SEEN IN A FOLLOW-UP VISIT AND DUPLEX ULTRASOUND DEMONSTRATED IMPAIRED BLOOD FLOW ABOUT 40 MM FROM THE FEMORAL BIFURCATION DETERMINED TO BE AN OCCLUSION WITHIN AND PROXIMAL TOO THE PROXIMAL STENT. APPROXIMATELY 3 WEEKS LATER (ON (B)(6) 2011) ANGIOGRAPHY CONFIRMED THE OCCLUSION PROXIMAL TO AND WITHIN THE PROXIMAL STENT. THE PATIENT UNDERWENT REVASCULARIZATION WITH BALLOON DILATION PERFORMED WITH A SLEEK, A SAVVY LONG, AND A CUTTING BALLOON; HOWEVER, A DISSECTION WAS NOTED AFTER USE OF THE SAVVY LONG. THEREFORE, A THIRD SMART CONTROL STENT WAS PLACED (DIAMETER 6 MM X LENGTH 80 MM), OVERLAPPING THE PROXIMAL SM-01 STENT. HIGH PRESSURE BALLOON DILATION WAS PERFORMED SEVERAL TIMES IN THE RESTENOSED SEGMENT OF THE STENT. SEQUENTIAL ANGIOGRAPHY DEMONSTRATED THE ADVANCE OF STENOSIS AT THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY WHICH WAS APPRECIATED THROUGHOUT THE PROXIMAL STENT DIFFUSELY, AND AN ADDITIONAL SMART CONTROL STENT WAS ALSO PLACED (DIAMETER 7 MM X LENGTH 40 MM) AT THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2011 DUPLEX ULTRASOUND REVEALED RE-OCCLUSION AT THE ORIGIN OF THE LEFT SUPERFICIAL FEMORAL ARTERY THROUGHOUT THE DISTAL STUDY STENT (C06100SV). ON (B)(6) 2011, REVASCULARIZATION WAS PERFORMED. ANGIOGRAPHY CONFIRMED A 19CM OCCLUSION 1 CM FROM THE FEMORAL BIFURCATION. BALLOON DILATATION WAS PERFORMED SEVERAL TIMES, AND PATENT VESSEL AND BLOOD FLOW WERE ACCOMPLISHED. ON (B)(6) 2011 DUPLEX ULTRASOUND DEMONSTRATED SUFFICIENT BLOOD FLOW, AND NO OCCLUSION WAS FOUND AT THE TREATED LESION. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. THE PATIENT'S MEDICAL HISTORY INCLUDES ANGINA, HYPERLIPIDEMIA, DIABETES MELLITUS, HEPATIC INSUFFICIENCY, DIABETIC RETINOPATHY AND BILATERAL NAIL TINEA. PHYSICIAN'S COMMENT (FOR RE-OCCLUSION (START DATE: (B)(6) 2011)) ON (B)(6) 2011, AT FOLLOW-UP VISIT, THE OCCLUSION WAS FOUND BY THE RESULTS OF THE EXAMS. I JUDGED TO BE REQUIRED PROCEDURE AND TREATMENT, AND REVASCULARIZATION WAS PERFORMED ON (B)(6) 2011. BASED ON ANGIOGRAPHY WHICH WAS PERFORMED ON THE SAME DAY, 10 CM OCCLUSION WITHIN THE STENT AS WELL AS PROXIMAL TO THE STENT WAS FOUND. ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, THE RE-TREATED SEGMENT WAS ALSO PRESENT IN THE STUDY DEVICE PLACEMENT. IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. PHYSICIAN'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)) SHORTLY AFTER THE PROCEDURE WHICH WAS PERFORMED ON (B)(6) 2011, INSUFFICIENCY OF PATENT VESSEL AND BLOOD FLOW WERE NOTED. THE CAUSE OF THE EVENT WAS CONSIDERED A PATIENT'S DIATHESIS WHICH WAS EASY TO COAGULATE BLOOD AND/OR THROMBUS CAUSED BY DISSECTION OCCURRED DURING PROCEDURE. HOWEVER, BECAUSE THE RE-TREATED SEGMENT WAS EXTENDED TO THE STUDY DEVICE, IT WAS ALSO JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. AN ADDITIONAL ANTITHROMBOTIC MEDICATION WAS STARTED ON (B)(6) 2011, AND REVASCULARIZATION WITH BALLOON DILATATION WAS PERFORMED ON (B)(6) 2011. A SUFFICIENT PATENT VESSEL WAS FOUND. PHYSICIAN'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)) ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, THE RE-TREATED SEGMENT WAS ALSO PRESENT IN THE STUDY DEVICE PLACEMENT. IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. IT WAS JUDGED TO BE POSSIBLE TO RULE OUT A CAUSAL RELATION TO THE REVASCULARIZATION WHICH WAS PERFORMED ON (B)(6) 2011. THE PHYSICIAN'S JUDGMENT WERE FOLLOWS: (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011) IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. IT WAS JUDGED TO BE CAUSAL RELATION TO HIS PRIMARY DISEASE (ARTERIOSCLEROTIC OBLITERATION). SAFETY ASSESSMENT COMMITTEE DOCTOR'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)): "I THOUGHT THE CAUSE OF THE REOCCLUSION WAS RELATED TO ENDOVASCULAR TREATMENT (EVT) FOR THE IN-STENT RESTENOSIS ON (B)(6). I SUPPOSED THE DISSECTION DUE TO BALLOON DILATATION WAS EXTENDED TO THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY, AND IT MIGHT HAVE BROUGHT ON THE OCCLUSION, BECAUSE THE DISSECTION WAS NOT COVERED AT THE ORIGIN WITH A STENT COMPLETELY. BECAUSE THERE IS NO BRANCH VESSEL IN THE SUPERFICIAL FEMORAL ARTERY, IN CASE THAT THE THREE STENTS WERE IMPLANTED LIKE THIS, ALL OF THE STENTS WOULD BE OCCLUDED EVEN IF ANY POINT WAS OCCLUDED. THEREFORE, IT COULD NOT BE DETERMINED WHETHER THE INITIAL STENTS WERE THE CAUSE. ON THE WHOLE, I THOUGHT THE EVT ON (B)(6) WAS TRIGGER THIS OCCLUSION, AND IT WAS JUDGED TO RULE OUT A CAUSAL RELATION TO THE INDEX PROCEDURE." DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. 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. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. 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. CONSIDERING THE MULTIPLE AREAS OF ATHEROSCLEROTIC DISEASE AND TOTAL LENGTH OF STENTS THAT WERE INITIALLY IMPLANTED IN THE LEFT SFA, IT IS LIKELY THAT THE PATIENT HAD DIFFUSE DISEASE THROUGHOUT BOTH LOWER EXTREMITIES. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF 4 DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2011-00445, 9616099-2011-00445, 9616099-2011-00542 AND 9616099-2011-00543.
ON (B)(6) 2011, THE ABI WAS 0.94 ON THE RIGHT AND 0.48 ON THE LEFT. DUPLEX ULTRASOUND REVEALED RE-OCCLUSION AT THE ORIGIN OF THE LEFT SUPERFICIAL FEMORAL ARTERY THROUGHOUT THE DISTAL STUDY STENT (C06100SV). ON (B)(6) 2011, REVASCULARIZATION WAS PERFORMED. ANGIOGRAPHY CONFIRMED A 19CM OCCLUSION 1 CM FROM THE FEMORAL BIFURCATION. BALLOON DILATATION WAS PERFORMED SEVERAL TIMES, AND PATENT VESSEL AND BLOOD FLOW WERE ACCOMPLISHED. ON (B)(6) 2011, THE ABI WAS 1.03 ON THE RIGHT AND 1.08 ON THE LEFT. DUPLEX ULTRASOUND DEMONSTRATED SUFFICIENT BLOOD FLOW, AND NO OCCLUSION WAS FOUND AT THE TREATED LESION. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. PHYSICIAN'S COMMENT (FOR RE-OCCLUSION (START DATE: (B)(6) 2011)) ON (B)(6) 2011, AT FOLLOW-UP VISIT, THE OCCLUSION WAS FOUND BY THE RESULTS OF THE EXAMS. I JUDGED TO BE REQUIRED PROCEDURE AND TREATMENT, AND REVASCULARIZATION WAS PERFORMED ON (B)(6) 2011. BASED ON ANGIOGRAPHY WHICH WAS PERFORMED ON THE SAME DAY, 10 CM OCCLUSION WITHIN THE STENT AS WELL AS PROXIMAL TO THE STENT WAS FOUND. ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, THE RE-TREATED SEGMENT WAS ALSO PRESENT IN THE STUDY DEVICE PLACEMENT. IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. THE PHYSICIAN'S JUDGMENT WERE FOLLOWS: (FOR REOCCLUSION (START DATE: (B)(6) 2011)) - IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. - IT WAS JUDGED TO BE CAUSAL RELATION TO HIS PRIMARY DISEASE (ARTERIOSCLEROTIC OBLITERATION). PHYSICIAN'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)) SHORTLY AFTER THE PROCEDURE WHICH WAS PERFORMED ON (B)(6) 2011, INSUFFICIENCY OF PATENT VESSEL AND BLOOD FLOW WERE NOTED. THE CAUSE OF THE EVENT WAS CONSIDERED A PATIENT'S DIATHESIS WHICH WAS EASY TO COAGULATE BLOOD AND/OR THROMBUS CAUSED BY DISSECTION OCCURRED DURING PROCEDURE. HOWEVER, BECAUSE THE RE-TREATED SEGMENT WAS EXTENDED TO THE STUDY DEVICE, IT WAS ALSO JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. AN ADDITIONAL ANTITHROMBOTIC MEDICATION WAS STARTED ON (B)(6) 2011, AND REVASCULARIZATION WITH BALLOON DILATATION WAS PERFORMED ON (B)(6) 2011. A SUFFICIENT PATENT VESSEL WAS FOUND. THE PHYSICIAN'S JUDGMENT WERE FOLLOWS: (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)) - IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. - IT WAS JUDGED TO BE CAUSAL RELATION TO PROCEDURE (THROMBOSIS ATTRIBUTED TO DISSECTION) AND HIS PRIMARY DISEASE (ARTERIOSCLEROTIC OBLITERATION). ADDITIONAL INFORMATION RECEIVED (B)(6) 2011 INDICATES THAT THROMBOSIS OCCURRED AGAIN IN THE SFA ON (B)(6) 2011: ON (B)(6) 2011, THE PATIENT WAS EXPERIENCED THE PAIN AND VISITED THE OFFICE. THE ABI WAS 0.97 ON THE RIGHT AND 0.58 ON THE LEFT. HE WAS ADMITTED FOR THE PURPOSE OF TREATMENT. WARFARIN TAB WAS GOING TO BE INCREASED TO 8MG/DAY (INTERNAL USE). HE STARTED ON HEPARIN SODIUM INJECTION 20,000 UNITS 2ML / HOUR (CONTINUOUS INFUSION) AND URONASE 240,000 UNITS 2ML / HOUR (CONTINUOUS INFUSION). REVASCULARIZATION WAS PERFORMED. ANGIOGRAPHY REVEALED THE 20 CM OCCLUSION WAS FOUND AT 1 CM FROM THE FEMORAL BIFURCATION. THE BALLOON DILATATION WAS PERFORMED SEVERAL TIMES, AND THE SUFFICIENCY OF PATENT VESSEL AND BLOOD FLOW WERE NOTED. PHYSICIAN'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)) ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, THE RE-TREATED SEGMENT WAS ALSO PRESENT IN THE STUDY DEVICE PLACEMENT. IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. IT WAS JUDGED TO BE POSSIBLE TO RULE OUT A CAUSAL RELATION TO THE REVASCULARIZATION WHICH WAS PERFORMED ON (B)(6) 2011. THE PHYSICIAN'S JUDGMENT WERE FOLLOWS: (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)) - IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. - IT WAS JUDGED TO BE CAUSAL RELATION TO HIS PRIMARY DISEASE (ARTERIOSCLEROTIC OBLITERATION). SAFETY ASSESSMENT COMMITTEE DOCTOR'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)). I THOUGHT THE CAUSE OF THE REOCCLUSION WAS RELATED TO EVT FOR THE IN-STENT RESTENOSIS ON (B)(6). I SUPPOSED THE DISSECTION DUE TO BALLOON DILATATION WAS EXTENDED TO THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY, AND IT MIGHT HAVE BROUGHT ON THE OCCLUSION, BECAUSE THE DISSECTION WAS NOT COVERED AT THE ORIGIN WITH A STENT COMPLETELY. BECAUSE THERE IS NO BRANCH VESSEL IN THE SUPERFICIAL FEMORAL ARTERY, IN CASE THAT THE THREE STENTS WERE IMPLANTED LIKE THIS, ALL OF THE STENTS WOULD BE OCCLUDED EVEN IF ANY POINT WAS OCCLUDED. THEREFORE, IT COULD NOT BE DETERMINED WHETHER THE INITIAL STENTS WERE THE CAUSE. ON THE WHOLE, I THOUGHT THE EVT ON (B)(6) WAS TRIGGER THIS OCCLUSION, AND IT WAS JUDGED TO RULE OUT A CAUSAL RELATION TO THE INDEX PROCEDURE. CONCOMITANT MEDICATIONS ((B)(6) 2011): WARFARIN TAB 5 MG/DAY (INTERNAL USE) AND HEPARIN SODIUM INJECTION 20,000 UNITS 2ML / HOUR (CONTINUOUS INFUSION) AND HE HAD BEEN ON DAILY PLETAL TAB 200MG SINCE BEFORE HE PARTICIPATED IN THE STUDY. AFTER PROCEDURE, HE WAS STARTED ON URONASE 240,000 UNITS 2ML / HOUR (CONTINUOUS INFUSION). CONCOMITANT DEVICES ((B)(6) 2011): UNKNOWN BALLOON. CONCOMITANT MEDICATIONS ((B)(6) 2011): WARFARIN TAB WAS GOING TO BE INCREASED TO 8MG/DAY (INTERNAL USE). HE STARTED ON HEPARIN SODIUM INJECTION 20,000 UNITS 2ML / HOUR (CONTINUOUS INFUSION) AND URONASE 240,000 UNITS 2ML / HOUR (CONTINUOUS INFUSION). CONCOMITANT DEVICES ((B)(6) 2011): UNKNOWN BALLOON. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF 4 DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9616099-2011-00445, 9616099-2011-00445, 9616099-2011-00542 AND 9616099-2011-00543.
THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THIS PATIENT WAS FOUND TO HAVE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) STENOSIS AND WAS ALLOCATED TO THE POBA (ANGIOPLASTY) GROUP. ON (B)(6) 2010, PTA WITH SLEEK AND SAVVY LONG BALLOONS WAS PERFORMED, BUT BAILOUT STENTING WAS PERFORMED WITH TWO SMART CONTROLS, A 6X80MM (PROXIMAL) AND A 6X100MM (DISTAL) DUE TO INADEQUATE PTA RESULTS. FIVE AND 1/2 MONTHS LATER, THE PATIENT WAS SEEN IN A FOLLOW-UP VISIT AND DUPLEX ULTRASOUND DEMONSTRATED IMPAIRED BLOOD FLOW ABOUT 40 MM FROM THE FEMORAL BIFURCATION DETERMINED TO BE AN OCCLUSION WITHIN AND PROXIMAL TOO THE PROXIMAL STENT. APPROXIMATELY 3 WEEKS LATER (ON (B)(6) 2011) ANGIOGRAPHY CONFIRMED THIS OCCLUSION. THE PATIENT UNDERWENT REVASCULARIZATION WITH BALLOON DILATION PERFORMED WITH A SLEEK, A SAVVY LONG, AND A CUTTING BALLOON; HOWEVER, A DISSECTION WAS NOTED AFTER USE OF THE SAVVY LONG. THEREFORE, A THIRD SMART CONTROL STENT WAS PLACED (DIAMETER 6 MM X LENGTH 80 MM), OVERLAPPING THE PROXIMAL SM-01 STENT. HIGH PRESSURE BALLOON DILATION WAS PERFORMED SEVERAL TIMES IN THE RESTENOSED SEGMENT OF THE STENT. SEQUENTIAL ANGIOGRAPHY DEMONSTRATED THE ADVANCE OF STENOSIS AT THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY WHICH WAS APPRECIATED THROUGHOUT THE PROXIMAL STENT DIFFUSELY, AND AN ADDITIONAL SMART CONTROL STENT WAS ALSO PLACED (DIAMETER 7 MM X LENGTH 40 MM) AT THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2011, DUPLEX ULTRASOUND REVEALED RE-OCCLUSION AT THE ORIGIN OF THE LEFT SUPERFICIAL FEMORAL ARTERY THROUGHOUT THE DISTAL STUDY STENT (B)(4). ON (B)(6) 2011, REVASCULARIZATION WAS PERFORMED. ANGIOGRAPHY CONFIRMED A 19CM OCCLUSION 1 CM FROM THE FEMORAL BIFURCATION. BALLOON DILATATION WAS PERFORMED SEVERAL TIMES, AND PATENT VESSEL AND BLOOD FLOW WERE ACCOMPLISHED. ON (B)(6) 2011, DUPLEX ULTRASOUND DEMONSTRATED SUFFICIENT BLOOD FLOW, AND NO OCCLUSION WAS FOUND AT THE TREATED LESION. ON (B)(6) 2011, RESTENOSIS WAS NOTED IN THE STUDY STENT AT LEFT SUPERFICIAL FEMORAL ARTERY, HOWEVER THE PERCENTAGE OF STENOSIS AND THE SPECIFIC STENTS INVOLVED WERE UNKNOWN. THE PATIENT DID NOT RECEIVE TREATMENT OR ADDITIONAL INTERVENTION FOR THIS AND WAS NOT TREATED AS THERE WAS ONLY MILD CLAUDICATION WITH AN ABI OF 0.80. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. THE PATIENTS MEDICAL HISTORY INCLUDES ANGINA, HYPERLIPIDEMIA, DIABETES MELLITUS, HEPATIC INSUFFICIENCY, DIABETIC RETINOPATHY AND BILATERAL NAIL TINEA. PHYSICIAN'S COMMENT (FOR RE-OCCLUSION (START DATE: (B)(6) 2011)): ON (B)(6) 2011, AT FOLLOW-UP VISIT, THE OCCLUSION WAS FOUND BY THE RESULTS OF THE EXAMS. I JUDGED TO BE REQUIRED PROCEDURE AND TREATMENT, AND REVASCULARIZATION WAS PERFORMED ON (B)(6) 2011. BASED ON ANGIOGRAPHY WHICH WAS PERFORMED ON THE SAME DAY, 10 CM OCCLUSION WITHIN THE STENT AS WELL AS PROXIMAL TO THE STENT WAS FOUND. ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, THE RE-TREATED SEGMENT WAS ALSO PRESENT IN THE STUDY DEVICE PLACEMENT. IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. PHYSICIAN'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)): SHORTLY AFTER THE PROCEDURE WHICH WAS PERFORMED ON (B)(6) 2011, INSUFFICIENCY OF PATENT VESSEL AND BLOOD FLOW WERE NOTED. THE CAUSE OF THE EVENT WAS CONSIDERED A PATIENT'S DIATHESIS WHICH WAS EASY TO COAGULATE BLOOD AND/OR THROMBUS CAUSED BY DISSECTION OCCURRED DURING PROCEDURE. HOWEVER, BECAUSE THE RE-TREATED SEGMENT WAS EXTENDED TO THE STUDY DEVICE, IT WAS ALSO JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. AN ADDITIONAL ANTITHROMBOTIC MEDICATION WAS STARTED ON (B)(6) 2011, AND REVASCULARIZATION WITH BALLOON DILATATION WAS PERFORMED ON (B)(6) 2011. A SUFFICIENT PATENT VESSEL WAS FOUND. PHYSICIAN'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)): ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, THE RE-TREATED SEGMENT WAS ALSO PRESENT IN THE STUDY DEVICE PLACEMENT. IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. IT WAS JUDGED TO BE POSSIBLE TO RULE OUT A CAUSAL RELATION TO THE REVASCULARIZATION WHICH WAS PERFORMED ON (B)(6) 2011. THE PHYSICIAN'S JUDGMENTS WERE AS FOLLOWS: (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011): IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. IT WAS JUDGED TO BE CAUSAL RELATION TO HIS PRIMARY DISEASE (ARTERIOSCLEROTIC OBLITERATION). SAFETY ASSESSMENT COMMITTEE DOCTOR'S COMMENT (FOR THROMBOSIS IN DEVICE (START DATE: (B)(6) 2011)): I THOUGHT THE CAUSE OF THE REOCCLUSION WAS RELATED TO ENDOVASCULAR TREATMENT (EVT) FOR THE IN-STENT RESTENOSIS ON (B)(6). I SUPPOSED THE DISSECTION DUE TO BALLOON DILATATION WAS EXTENDED TO THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY, AND IT MIGHT HAVE BROUGHT ON THE OCCLUSION, BECAUSE THE DISSECTION WAS NOT COVERED AT THE ORIGIN WITH A STENT COMPLETELY. BECAUSE THERE IS NO BRANCH VESSEL IN THE SUPERFICIAL FEMORAL ARTERY, IN CASE THAT THE THREE STENTS WERE IMPLANTED LIKE THIS, ALL OF THE STENTS WOULD BE OCCLUDED EVEN IF ANY POINT WAS OCCLUDED. THEREFORE, IT COULD NOT BE DETERMINED WHETHER THE INITIAL STENTS WERE THE CAUSE. ON THE WHOLE, I THOUGHT THE EVT ON (B)(6) WAS TRIGGER THIS OCCLUSION, AND IT WAS JUDGED TO RULE OUT A CAUSAL RELATION TO THE INDEX PROCEDURE. 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. THROMBOSIS/RESTENOSIS 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 INSIDE OF THE STENT AROUND THE DAMAGED AREAS. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. 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. CONSIDERING THE MULTIPLE AREAS OF ATHEROSCLEROTIC DISEASE AND TOTAL LENGTH OF STENTS THAT WERE INITIALLY IMPLANTED IN THE LEFT SFA, IT IS LIKELY THAT THE PATIENT HAD DIFFUSE DISEASE THROUGHOUT BOTH LOWER EXTREMITIES. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF 4 DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 9616099-2011-00445, 9616099-2011-00445, 9616099-2011-00542 AND 9616099-2011-00543.
UPDATED INFORMATION WAS RECEIVED FOR THIS FILE ON (B)(4). THE UPDATED INFORMATION HAS BEEN MERGED WITH THE ORIGINAL DATA IN THE SUMMARY HEREIN. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THIS PATIENT WAS FOUND TO HAVE LEFT SFA STENOSIS AND WAS ALLOCATED TO THE POBA GROUP. ON (B)(6) 2010, PTA WITH SLEEK AND SAVVY LONG BALLOONS WAS PERFORMED, BUT BAILOUT STENTING WAS PERFORMED WITH TWO SMART CONTROLS, A 6X80MM (PROXIMAL) AND A 6X100MM (DISTAL). FIVE AND 1/2 MONTHS LATER, THE PATIENT WAS SEEN IN A FOLLOW-UP VISIT AND DUPLEX ULTRASOUND DEMONSTRATED IMPAIRED BLOOD FLOW AROUND 40 MM FROM THE FEMORAL BIFURCATION. THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION WITHIN THE PROXIMAL STENT AS WELL AS PROXIMAL TO THAT STENT. THE ABI WAS 1.08 ON THE RIGHT AND 0.72 ON THE LEFT. THE PATIENT UNDERWENT REVASCULARIZATION APPROXIMATELY 3 WEEKS LATER. ANGIOGRAPHY ON (B)(6) 2011 CONFIRMED A 10 CM OCCLUSION PROXIMAL TO AND WITHIN THE PROXIMAL STENT. BALLOON DILATION WAS PERFORMED AT THE LESION WITH A SLEEK, A SAVVY LONG, AND A CUTTING BALLOON; HOWEVER, A DISSECTION WAS NOTED AFTER USE OF THE SAVVY LONG BALLOON. THEREFORE, A THIRD SMART CONTROL STENT WAS PLACED (DIAMETER 6 MM X LENGTH 80 MM), OVERLAPPING THE PROXIMAL SM-01 STENT, AS A BAILOUT PROCEDURE. HIGH PRESSURE BALLOON DILATION WAS PERFORMED SEVERAL TIMES IN THE RESTENOSED SEGMENT OF THE STENT. SEQUENTIAL ANGIOGRAPHY DEMONSTRATED THE ADVANCE OF STENOSIS AT THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY WHICH WAS APPRECIATED THROUGHOUT THE PROXIMAL STENT DIFFUSELY, AND AN ADDITIONAL SMART CONTROL STENT WAS ALSO PLACED (DIAMETER 7 MM X LENGTH 40 MM) AT THE ORIGIN OF THE SUPERFICIAL FEMORAL ARTERY. ALTHOUGH THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS (NIO) | NIO | CORDIS DE MEXICO | NA | 15265440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| L| R |