CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00311
- Event Type
- Injury
- Date Received
- September 1, 2010
- Date of Event
- May 23, 2012
- Report Date
- July 19, 2012
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
BASED ON THE NEW EVENTS REPORTED, AN ADDITIONAL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL CLARIFICATION IS PENDING AND ALL WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES: ((B)(6)2010): 6 F XB 3.5 GUIDE, 2.0X12 MM MAVERICK BALLOON, 2.5X12 MM QUANTUM BALLOON. CONCOMITANT MEDICATIONS : ((B)(6) 2010): PRE AND POST-PROCEDURE MEDICATIONS INCLUDE PLAVIX. ASPIRIN ALSO PRESCRIBED POST-PROCEDURE. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00311 AND 3003742446-2011-00129.
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 15061563 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
ADDITIONAL INFORMATION INDICATED THAT APPROXIMATELY THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS AND A MYOCARDIAL INFARCTION. INITIAL INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS SHORTLY FOLLOWED BY A THROMBOTIC EVENT AND MYOCARDIAL INFARCTION. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, HYPERTENSION, AND PREVIOUS PCI, AND PREVIOUS CABG, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF PERIPHERAL ARTERY DISEASE, PVD/CLAUDICATION, PROSTATE CANCER AND HISTORY OF SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA AND A POSITIVE STRESS TEST. THE TARGET LESIONS WERE THE PROXIMAL CIRCUMFLEX (CFX) AND THE MID RAMUS. THE CFX WAS DESCRIBED AS DE NOVO, TORTUOUS AND 90% STENOSED. A 2.5MM X 18MM CYPHER STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS, AN ATTEMPT WAS THEN MADE WITH AN ABBOT STENT BUT THIS TOO FAILED TO CROSS. THE LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY. THE RAMUS WAS DESCRIBED AS DE NOVO AND 99% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 13MM CYPHER STENT AT 16 ATMS, FOLLOWED BY POST-DILATION FOR OPTIMAL APPOSITION. APPROXIMATELY SEVEN MONTHS LATER, CHEST PAIN INSPIRED ANGIOGRAPHY REVEALED RESTENOSIS IN THE PREVIOUSLY IMPLANTED STENT. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY AND THE IMPLANT OF A 2.25MM X 13MM CYPHER STENT, FOLLOWED BY POST-DILATION. THE REPORTED RESIDUAL STENOSIS WAS 0% WITH A TIMI FLOW OF 3. SEVEN DAYS LATER, THE PATIENT HAD NON ST ELEVATION MI AND SUB-ACUTE STENT THROMBOSIS. THE CYPHER STENT IMPLANTED IN THE PROXIMAL RAMUS THE WEEK BEFORE WAS TOTALLY OCCLUDED WITH THROMBUS. THIS AREA WAS TREATED WITH A 2.0X12MM BALLOON. THIS SHOWED THAT THERE WAS HAZINESS THROUGHOUT THE STENT AND THE AREA BEYOND IT. THE JUMP GRAFT WAS TOTALLY OCCLUDED AS WAS THE SECOND OM. THIS AREA WAS THEREFORE TREATED WITH A 2.25X23MM CYPHER AND POST-DILATED WITH A 2.5X15 NC VOYAGER BALLOON WITH FINAL TIMI III FLOW INTO THE RAMUS. THE VEIN GRAFT WHICH WAS A JUMP GRAFT FROM THE RAMUS WAS TOTALLY OCCLUDED. THE PATIENT WAS CHEST PAIN FREE AND HEMODYNAMICALLY STABLE POST PROCEDURE. THE PATIENT REPORTED THAT HE HAD BEEN COMPLIANT WITH PLAVIX. PLEASE NOTE THAT THE DATABASE REFERS TO THE TREATED VESSEL AS THE RAMUS, THE REPEAT ANGIOGRAPHY ON (B)(6) 2010 REFERS TO THE VESSEL AS THE FIRST OM AND THE SUBSEQUENT ANGIOGRAPHY ON (B)(6) 2010 AGAIN REFERS TO THE STENTED VESSEL AS THE RAMUS. APPROXIMATELY THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS OF THE STENTS IN THE RAMUS BRANCH WITH RESULTING MYOCARDIAL INFARCTION THE EVENT WAS TREATED WITH PTCA AND THE EVENT RESOLVED WITHOUT FURTHER SEQUEL. 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. RESTENOSIS AND MI ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S EXTENSIVE MEDICAL HISTORY INCLUDING THE PATIENT'S EXTENSIVE CARDIOVASCULAR DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00311 AND 3003742446-2011-00129.
ADDITIONAL INFORMATION RECEIVED THAT THE DATE OF PREVIOUSLY REPORTED MI AND RESTENOSIS WAS REVISED FROM (B)(6) 2011 TO (B)(6) 2011. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00311 AND 3003742446-2011-00129.
INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS SHORTLY FOLLOWED BY A THROMBOTIC EVENT AND MYOCARDIAL INFARCTION. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, HYPERTENSION, PREVIOUS PCI, PREVIOUS CABG, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF PERIPHERAL ARTERY DISEASE, PVD/CLAUDICATION, PROSTATE CANCER, AND HISTORY OF SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA AND A POSITIVE STRESS TEST. THE TARGET LESIONS WERE THE PROXIMAL CIRCUMFLEX (CFX) AND THE MID RAMUS. THE CFX WAS DESCRIBED AS DE NOVO, TORTUOUS AND 90% STENOSED. A 2.5 MM X 18 MM CYPHER STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS, AN ATTEMPT WAS THEN MADE WITH AN ABBOT STENT, BUT THIS TOO FAILED TO CROSS. THE LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY. THE RAMUS WAS DESCRIBED AS DE NOVO AND 99% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5 MM X 13 MM CYPHER STENT AT 16 ATMS, FOLLOWED BY POST-DILATION FOR OPTIMAL APPOSITION. APPROXIMATELY (B)(6) MONTHS LATER CHEST PAIN INSPIRED ANGIOGRAPHY REVEALED RESTENOSIS IN THE PREVIOUSLY IMPLANTED STENT. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY AND THE IMPLANT OF A 2.25 MM X 13 MM CYPHER STENT, FOLLOWED BY POST-DILATION. THE REPORTED RESIDUAL STENOSIS WAS 0% WITH A TIMI FLOW OF 3. (B)(6) DAYS LATER, THE PATIENT HAD NON-ST ELEVATION MI AND SUB-ACUTE STENT THROMBOSIS. THE CYPHER STENT IMPLANTED IN THE PROXIMAL RAMUS THE (B)(6) BEFORE WAS TOTALLY OCCLUDED WITH THROMBUS. THIS AREA WAS TREATED WITH A 2.0X12 MM BALLOON. THIS SHOWED THAT THERE WAS HAZINESS THROUGHOUT THE STENT AND THE AREA BEYOND IT. THE JUMP GRAFT WAS TOTALLY OCCLUDED AS WAS THE SECOND OM. THIS AREA WAS THEREFORE TREATED WITH A 2.25X23 MM CYPHER AND POST-DILATED WITH A 2.5X15 NC VOYAGER BALLOON WITH FINAL TIMI III FLOW INTO THE RAMUS. THE VEIN GRAFT WHICH WAS A JUMP GRAFT FROM THE RAMUS WAS TOTALLY OCCLUDED. THE PATIENT WAS CHEST PAIN FREE AND HEMODYNAMICALLY STABLE POST PROCEDURE. THE PATIENT REPORTED THAT HE HAD BEEN COMPLIANT WITH PLAVIX. PLEASE NOTE THAT THE DATABASE REFERS TO THE TREATED VESSEL AS THE RAMUS, THE REPEAT ANGIOGRAPHY ON (B)(6) 2010, REFERS TO THE VESSEL AS THE FIRST OM AND THE SUBSEQUENT ANGIOGRAPHY ON (B)(6) 2010, AGAIN REFERS TO THE STENTED VESSEL AS THE RAMUS. THE DHR FOR (B)(4), 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. RESTENOSIS, SUB-ACUTE STENT THROMBOSIS AND MI ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S EXTENSIVE MEDICAL HISTORY INCLUDING THE PATIENT'S EXTENSIVE CARDIOVASCULAR DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00311 AND 3003742446-2011-00129.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PREVIOUSLY REPORTED ELEVATED CARDIAC ENZYMES POST-PROCEDURE WAS EVALUATED AS AN MI PER ARC DEFINITION. THE RELATIONSHIP TO THE STUDY DEVICE WAS PROBABLE. NO TREATMENT WAS PROVIDED AND IT RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION INDICATED THAT APPROXIMATELY THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS AND A MYOCARDIAL INFARCTION. INITIAL INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS SHORTLY FOLLOWED BY A THROMBOTIC EVENT AND MYOCARDIAL INFARCTION. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, HYPERTENSION, AND PREVIOUS PCI, AND PREVIOUS CABG, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF PERIPHERAL ARTERY DISEASE, PVD/CLAUDICATION, PROSTATE CANCER AND HISTORY OF SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA AND A POSITIVE STRESS TEST. THE TARGET LESIONS WERE THE PROXIMAL CIRCUMFLEX (CFX) AND THE MID RAMUS. THE CFX WAS DESCRIBED AS DE NOVO, TORTUOUS AND 90% STENOSED. A 2.5MM X 18MM CYPHER STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS, AN ATTEMPT WAS THEN MADE WITH AN ABBOT STENT BUT THIS TOO FAILED TO CROSS. THE LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY. THE RAMUS WAS DESCRIBED AS DE NOVO AND 99% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 13MM CYPHER STENT AT 16 ATMS, FOLLOWED BY POST-DILATION FOR OPTIMAL APPOSITION. POST PROCEDURE THE CARDIAC ENZYMES WERE ELEVATED, ACCORDING TO (B)(4) ADJUDICATION THIS EVENT WILL BE CAPTURED AS AN ASC DEFINITION MI. THE RELATIONSHIP TO THE STUDY DEVICE IS PROBABLY. NO SPECIFIC TREATMENT WAS ADMINISTERED. APPROXIMATELY SEVEN MONTHS LATER, CHEST PAIN INSPIRED ANGIOGRAPHY REVEALED RESTENOSIS IN THE PREVIOUSLY IMPLANTED STENT. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY AND THE IMPLANT OF A 2.25MM X 13MM CYPHER STENT, FOLLOWED BY POST-DILATION. THE REPORTED RESIDUAL STENOSIS WAS 0% WITH A TIMI FLOW OF 3. SEVEN DAYS LATER, THE PATIENT HAD NON ST ELEVATION MI AND SUB-ACUTE STENT THROMBOSIS. THE CYPHER STENT IMPLANTED IN THE PROXIMAL RAMUS THE WEEK BEFORE WAS TOTALLY OCCLUDED WITH THROMBUS. THIS AREA WAS TREATED WITH A 2.0X12MM BALLOON. THIS SHOWED THAT THERE WAS HAZINESS THROUGHOUT THE STENT AND THE AREA BEYOND IT. THE JUMP GRAFT WAS TOTALLY OCCLUDED AS WAS THE SECOND OM. THIS AREA WAS THEREFORE TREATED WITH A 2.25X23MM CYPHER AND POST-DILATED WITH A 2.5X15 NC VOYAGER BALLOON WITH FINAL TIMI III FLOW INTO THE RAMUS. THE VEIN GRAFT WHICH WAS A JUMP GRAFT FROM THE RAMUS WAS TOTALLY OCCLUDED. THE PATIENT WAS CHEST PAIN FREE AND HEMODYNAMICALLY STABLE POST PROCEDURE. THE PATIENT REPORTED THAT HE HAD BEEN COMPLIANT WITH PLAVIX. PLEASE NOTE THAT THE DATABASE REFERS TO THE TREATED VESSEL AS THE RAMUS, THE REPEAT ANGIOGRAPHY ON (B)(6) 2010 REFERS TO THE VESSEL AS THE FIRST OM AND THE SUBSEQUENT ANGIOGRAPHY ON (B)(6) 2010 AGAIN REFERS TO THE STENTED VESSEL AS THE RAMUS. APPROXIMATELY THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS OF THE STENTS IN THE RAMUS BRANCH WITH RESULTING MYOCARDIAL INFARCTION THE EVENT WAS TREATED WITH PTCA AND THE EVENT RESOLVED WITHOUT FURTHER SEQUELAE. THE INDEX STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 15061563 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. LATE THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH DRUG ELUTING 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. ELUTED DRUGS INHIBIT EPITHELIALIZATION IN AN EFFORT TO PREVENT RESTENOSIS. DUAL ANTI-PLATELET THERAPY IS USED TO ASSIST IN THE PREVENTION OF THROMBUS ON THE INSIDE OF THE STENT, SECONDARY TO PLATELETS ATTACHING TO THE DISTURBED INTIMAL LAYERS AND METAL STENT STRUTS POST STENT IMPLANTATION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION, PATIENT AND PROCEDURAL ISSUES MAY ALL HAVE CONTRIBUTED TO THE REPORTED EVENTS.
COMPLAINT CONCLUSION: THE COMPLAINTS RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT EXPERIENCED MULTIPLE EPISODES OF MI'S AND RESTENOSIS FOLLOWING THE INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, HYPERTENSION, AND PREVIOUS PCI, AND PREVIOUS CABG, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF PERIPHERAL ARTERY DISEASE, PVD/CLAUDICATION, PROSTATE CANCER AND HISTORY OF SMOKING. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA AND A POSITIVE STRESS TEST. THE TARGET LESIONS WERE THE PROXIMAL CIRCUMFLEX (CFX) AND THE MID RAMUS. THE CFX WAS DESCRIBED AS DE NOVO, TORTUOUS AND 90% STENOSED. A 2.5MM X 18MM CYPHER STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS, AN ATTEMPT WAS THEN MADE WITH AN ABBOTT STENT BUT THIS TOO FAILED TO CROSS. THE LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY. THE RAMUS WAS DESCRIBED AS DE NOVO AND 99% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 13MM CYPHER STENT AT 16 ATMS, FOLLOWED BY POST-DILATION FOR OPTIMAL APPOSITION. POST PROCEDURE THE CARDIAC ENZYMES WERE ELEVATED, ACCORDING TO (B)(4) ADJUDICATION THIS EVENT WILL BE CAPTURED AS AN ASC DEFINITION MI. THE RELATIONSHIP TO THE STUDY DEVICE IS PROBABLY. NO SPECIFIC TREATMENT WAS ADMINISTERED. APPROXIMATELY SEVEN MONTHS LATER CHEST PAIN INSPIRED ANGIOGRAPHY REVEALED RESTENOSIS IN THE PREVIOUSLY IMPLANTED STENT. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY AND THE IMPLANT OF A 2.25MM X 13MM CYPHER STENT, FOLLOWED BY POST-DILATION. THE REPORTED RESIDUAL STENOSIS WAS 0% WITH A TIMI FLOW OF 3. SEVEN DAYS LATER, THE PATIENT HAD NON ST ELEVATION MI AND SUB-ACUTE STENT THROMBOSIS. THE CYPHER STENT IMPLANTED IN THE PROXIMAL RAMUS THE WEEK BEFORE WAS TOTALLY OCCLUDED WITH THROMBUS. THIS AREA WAS TREATED WITH A 2.0X12MM BALLOON. THIS SHOWED THAT THERE WAS HAZINESS THROUGHOUT THE STENT AND THE AREA BEYOND IT. THE JUMP GRAFT WAS TOTALLY OCCLUDED AS WAS THE SECOND OM. THIS AREA WAS THEREFORE, TREATED WITH A 2.25X23MM CYPHER AND POST-DILATED WITH A 2.5X15 NC VOYAGER BALLOON WITH FINAL TIMI III FLOW INTO THE RAMUS. THE VEIN GRAFT WHICH WAS A JUMP GRAFT FROM THE RAMUS WAS TOTALLY OCCLUDED. THE PATIENT WAS CHEST PAIN FREE AND HEMODYNAMICALLY STABLE POST PROCEDURE. THE PATIENT REPORTED THAT HE HAD BEEN COMPLIANT WITH PLAVIX. PLEASE NOTE THAT THE DATABASE REFERS TO THE TREATED VESSEL AS THE RAMUS, THE REPEAT ANGIOGRAPHY ON (B)(6) 2010, REFERS TO THE VESSEL AS THE FIRST OM AND THE SUBSEQUENT ANGIOGRAPHY ON (B)(6) 2010, AGAIN REFERS TO THE STENTED VESSEL AS THE RAMUS. APPROXIMATELY THIRTEEN MONTHS AFTER THE INDEX PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS OF THE STENTS IN THE RAMUS BRANCH WITH RESULTING MYOCARDIAL INFARCTION THE EVENT WAS TREATED WITH PTCA AND THE EVENT RESOLVED WITHOUT FURTHER SEQUELA. ADDENDUM ((B)(6) 2011): ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT RETURNED WITH A MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED THAT THERE WAS GREATER THAN 50% IN-STENT RESTENOSIS OF THE STENTED SEGMENT IN THE RAMUS THAT WAS TREATED WITH PTCA. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PATIENT EXPERIENCED INSTENT RESTENOSIS APPROXIMATELY TWENTY-SEVEN MONTHS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSTENT RESTENOSIS AND UNDERWENT PTCA OF THE NATIVE RAMUS. THE PERCENTAGE OF RESTENOSIS WAS 99%. ACCORDING TO THE CATH REPORT, THE OM1 WAS ALSO COMPLETELY OCCLUDED ON (B)(6) 2012. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. IN AN INVESTIGATOR'S OPINION, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY STENT AND DRUG. THE INDEX STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 15061563 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CHEST PAIN IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE CYPHER IFU AS SUCH. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THE NATURAL PROGRESSION OF CORONARY DISEASE AS WELL AS TARGET LESION ISSUES MAY CONTRIBUTE TO THE EXPERIENCE OF CHEST PAIN / ANGINA. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. LATE THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH DRUG ELUTING 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. ELUTED DRUGS INHIBIT EPITHELIALIZATION IN AN EFFORT TO PREVENT RESTENOSIS. DUAL ANTI-PLATELET THERAPY IS USED TO ASSIST IN THE PREVENTION OF THROMBUS ON THE INSIDE OF THE STENT, SECONDARY TO PLATELETS ATTACHING TO THE DISTURBED INTIMAL LAYERS AND METAL STENT STRUTS POST STENT IMPLANTATION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION, PATIENT AND PROCEDURAL ISSUES MAY ALL HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00311AND 3003742446-2011-00129.
(B)(6) 2010 17:30 24 HR CLOCK: CK 281 (UL 397 IU/L), CK-MB 7.1 (UL 6.3 NG/ML), TROPONIN I 0.15 (0.49 NG/ML). (B)(6) 2010 23:15 24 HR CLOCK: CK 322 (UL 397 IU/L), CK-MB 15.2 (UL 6.3 NG/ML), TROPONIN I 1.19 (UL 0.49 NG/ML). (B)(6) 2010 04:30 24 HR CLOCK: CK 319 (UL 397 IU/L), CK-MB 19.2 (UL 6.3 NG/ML) AND TROPONIN I 2.53 (UL 0.49 NG/ML). (B)(6) 2010 10:25 24 HR CLOCK: CK 283 (UL 397 IU/L), CK-MB 17.3 (UL 6.3 NG/ML) AND TROPONIN I 2.93 (UL 0.49 NG/ML). ASPIRIN 325MG (START (B)(6) 2010 - STOPPED (B)(6) 2010), LOVASTATIN 20MG (START 1994), ISOSORBIDE 30MG (START 1994), ATENOLOL 25MG (START 1994) AND ASPIRIN 81MG (START (B)(6) 2010). THE DEVICE REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
ADDENDUM ((B)(4) 2013): ADDITIONAL INFORMATION THROUGH CEC ADJUDICATION MINUTES INDICATED THAT ON (B)(6) 2011, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. ON (B)(6) 2011 AT 03:42, THE CK WAS 179 (NL 397, RATIO <1), THE CKMB WAS 10.8 (NL 6.3, RATIO 1.7) AND THE TROPONIN WAS 0.81 (NL 0.49, RATIO 1.7). ON (B)(6) 2011 AT 13:47, THE CK WAS 146 (RATIO <1), THE CKMB WAS 8.7 (RATIO 1.4) AND THE TROPONIN WAS 0.84 (RATIO 1.7). ON (B)(6) 2011 AT 14:07, THE CK WAS 83 (RATIO <1), THE CKMB WAS 2.8 (RATIO <1) AND THE TROPONIN WAS 0.32 (RATIO <1). ON (B)(6) 2011 AT 20:16, THE CK WAS 155 (RATIO <1), THE CKMB WAS 2.8 (RATIO <1) AND THE TROPONIN WAS 0.36 (RATIO <1). ON (B)(6) 2011 AT 02:28, THE CK WAS 90 (RATIO <1), THE CKMB WAS 2.5 (RATIO <1) AND THE TROPONIN WAS 0.31 (RATIO <1). IN THE EMERGENCY ROOM ON (B)(6) 2011, ECG SHOWED NORMAL SINUS RHYTHM, LEFT VENTRICULAR HYPERTROPHY WITH LEFT AXIS DEVIATION. THE ECG CORE LAB REPORTED THAT THE ECG WAS UNINTERPRETABLE DUE TO INADEQUATE TRACING QUALITY AND MISSING LEADS. ECHOCARDIOGRAM PERFORMED ON (B)(6) 2011 REVEALED INFERIOR/INFEROLATERAL HYPOKINESIS, MILD CONCENTRIC LEFT VENTRICULAR HYPERTROPHY AND LVEF 45-50%. THE SITE REPORTED A NON-Q WAVE MI OCCURRING ON (B)(6) 2011. ON (B)(6) 2011 REPEAT ANGIOGRAPHY REVEALED THE LAD HAD A 50% TUBULAR STENOSIS IN THE PROXIMAL SEGMENT, PER PROVIDED CATHETERIZATION REPORT. THE MIDPORTION WAS SUBTOTALLY OCCLUDED. BEYOND THAT IT FILLED VIA THE LIMA GRAFT. BEYOND THE LIMA GRAFT INSERTION A FOCAL 90% STENOSIS WAS NOTED. FURTHERMORE, THE PROXIMAL CX HAD A "REGULAR" 60-70% DISEASE, AND THE 1ST OM AND 2ND OM WERE BOTH TOTALLY OCCLUDED. THE PROXIMAL RAMUS HAD A 70% IN-STENT RESTENOSIS, AND BEYOND THE STENT THERE WAS A 90% FOCAL STENOSIS WHICH WAS NEW. ANGIOGRAPHIC CORE LAB ANALYSIS REVEALED A 48% RESTENOSIS IN THE PROXIMAL CX WITH TIMI 3 FLOW, AND NO EVIDENCE OF THROMBUS. ANGIOGRAPHIC CORE LAB ANALYSIS REVEALED A 64% MARGINAL IN-STENT RESTENOSIS IN THE RAMUS WITH TIMI 3 FLOW, NO EVIDENCE OF THROMBUS AND THE FOLLOWING COMMENT: "TARGET LESION REVASCULARIZATION AND NON-TARGET VESSEL REVASCULARIZATION." ON (B)(6) 2011 AT 07:47, THE PATIENT UNDERWENT SUCCESSFUL TREATMENT WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE DRUG-ELUTING STENT IN THE LAD BEYOND THE LIMA, AS NOTED IN THE INTERVENTIONAL CATHETERIZATION REPORT. THE 90% STENOSIS IN THE RAMUS WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY AND THE PLACEMENT OF ONE DRUG-ELUTING STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 ON ANTIPLATELET THERAPY. PLEASE NOTE THAT THIS NEW INFORMATION DOES NOT CHANGE ANY REPORTABILITY/DETERMINATION OF THIS FILE AS THE CODES FOR MI AND CORONARY ARTERY RESTENOSIS WERE PREVIOUSLY CAPTURED AT THE TIME OF INITIAL REPORT. HOWEVER THE EVENT DATE OF PREVIOUSLY REPORTED MI HAS BEEN CHANGED TO (B)(6) 2011 BASED ON THE ABOVE INFO.
A PATIENT FROM THE (B)(4) STUDY HAD INCREASED ENZYMES POST IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDES HYPERLIPIDEMIA, HYPERTENSION, PREVIOUS PCI ((B)(6) 2010), PREVIOUS CABG (1994), FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HISTORY OF PERIPHERAL ARTERY DISEASE, PVD/CLAUDICATION, PROSTATE CANCER (2009) AND HISTORY OF SMOKING. PCI WAS CONDUCTED TO TREAT A 16MM, 90%, TYPE C DE NOVO, LESION IN THE PROXIMAL LCX WITH SEVERE TORTUOSITY AND AN 11MM, 99%, TYPE C, DE NOVO STENOSIS IN THE MID RAMUS ARTERY. ATTEMPTS TO GET TWO DIFFERENT STENTS ACROSS THE LESION IN THE PROXIMAL LCX WERE UNSUCCESSFUL. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. THE LESION IN THE MID RAMUS WAS PRE-DILATED BEFORE A 2.5 X 13MM CYPHER STENT WAS DEPLOYED TO 16 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 3.0 X 3MM BALLOON INFLATED TO 20 ATM PER STANDARD PROCEDURE. 16-24 HOURS AFTER THE PROCEDURE, THE PATIENT'S CARDIAC ENZYMES VALUES INCREASED TO > 3 TIMES ULN (CK-MB 19.2, UPPER LIMIT 6.3 NG/ML) AND TROPONIN 2.53 (UPPER LIMIT 0.49 NG/ML). TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH CK 283 (UL 397 IU/L), CK-MB 17.3 (UL 6.3 NG/ML) AND TROPONIN I 2.93 (UL 0.49 NG/ML). THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE MULTIPLE EFFORTS TO CROSS TWO DIFFERENT PRODUCTS IN THE PROXIMAL CIRCUMFLEX LESION AND MULTIPLE BALLOON DILATIONS CONDUCTED MAY HAVE CONTRIBUTED TO THE ELEVATED ENZYME LEVELS RECORDED POST-PROCEDURE. THEREFORE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (TORTUOSITY, TYPE C) AND INHERENTLY PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.
ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY (B)(6) MONTHS POST-PROCEDURE THE PATIENT RETURNED WITH CHEST PAIN AND DUE TO A POSITIVE STRESS TEST, LEFT HEART CATHETERIZATION AND PERCUTANEOUS INTERVENTION WAS PERFORMED. ANGIOGRAPHY REVEALED 99% STENOSIS OF THE PREVIOUSLY IMPLANTED STENT. IT WAS TREATED WITH A 2.25X13 MM CYPHER STENT. THE PATIENT PRESENTED (B)(6) WEEK LATER WITH CHEST PAIN AND NON ST ELEVATION MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED THAT THE PREVIOUSLY IMPLANTED STENT IN THE RAMUS WAS TOTALLY OCCLUDED, REPRESENTED AS SUB ACUTE STENT THROMBOSIS. INTEGRILLIN WAS ALREADY INFUSING AND HEPARIN WAS ADDED FOR ANTICOAGULATION. THE STENT WAS ADDRESSED WITH A 2.0X12 OVER THE WIRE APEX AND A RUN-THOUGH WIRE. THE TOTALLY OCCLUDED STENT WAS CROSSED WITH SOME DIFFICULTY. THE WIRE WAS ADVANCED INTO THE RAMUS AND THE OCCLUDED AREA WAS TREATED WITH A 2.0X12 MM BALLOON. THIS SHOWED THAT THERE WAS SOME HAZINESS THROUGHOUT THE STENT AND THE AREA BEYOND IT. THE JUMP GRAFT WAS TOTALLY OCCLUDED AS WAS THE SECOND OM. THIS AREA WAS TREATED WITH A 2.25X23 MM CYPHER AND POST-DILATED WITH A 2.5X15 NC VOYAGER WITH A FINAL RESULTANT REDUCTION OF STENOSIS TO 0% WITH TIMI III FLOW INTO THE RAMUS. ALL THE GRAFTS WERE OCCLUDED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT RETURNED WITH A MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED THAT THERE WAS GREATER THAN 50% IN-STENT RESTENOSIS OF THE STENTED SEGMENT IN THE RAMUS.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PATIENT EXPERIENCED INSTENT RESTENOSIS APPROXIMATELY TWENTY-SEVEN MONTHS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSTENT RESTENOSIS AND UNDERWENT PTCA OF THE NATIVE RAMUS. THE PERCENTAGE OF RESTENOSIS WAS 99%. ACCORDING TO THE CATH REPORT, THE OM1 WAS ALSO COMPLETELY OCCLUDED ON (B)(6) 2012. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. IN AN INVESTIGATOR'S OPINION, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY STENT AND DRUG.
THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 99% STENOSIS IN THE RAMUS ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5 X 12MM BALLOON AT 10 ATM. THE LESION WAS DE NOVO AND TYPE C. A 2.5 X 13MM CYPHER STENT WAS DEPLOYED AT 16 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 3.0 X 3MM BALLOON AT 20 ATM PER STANDARD PROCEDURE. 16-24 HOURS AFTER THE PROCEDURE, THE PATIENT'S CARDIAC ENZYMES VALUES INCREASED, INDICATIVE OF A MYOCARDIAL INFARCTION (CK-MB 19.2, UPPER LIMIT 6.3 NG/ML). THE PATIENT HAD NO ANGINA OR ADVERSE EVENT DURING THE 30 DAYS FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | 15061563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | ABBOTT XIENCE V 2.50 X 18MM |