CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00451
- Event Type
- Death
- Date Received
- October 26, 2011
- Date of Event
- September 9, 2011
- Report Date
- October 4, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
CEC ADJUDICATION MINUTES WERE RECEIVED ON (B)(6), 2011 AND THE FOLLOWING WAS NOTED: THE COMMITTEE AGREED WITH LATE STENT THROMBOSIS (PROTOCOL DEFINED), FOR SEPTEMBER 19, 2011; AND POSSIBLE STENT THROMBOSIS (ARC),ON (B)(6), 2011. THE FILE WILL BE UPDATED WITH THE CODE FOR STENT THROMBOSIS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00450, 3003742446-2011-00451 AND 3003742446-2011-00452. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
ADDENDUM (02/22/2012): CEC ADJUDICATION MINUTES WERE RECEIVED ON FEBRUARY 22, 2012 AND THE FOLLOWING WAS NOTED. THE COMMITTEE AGREED WITH THE CODING OF ARC (PERI-PROCEDURAL PCI), (B)(6) 2010 BASED ON A TROPONIN I PEAK OF 0.31 (0.08 ULN). THIS IS BEING REPORTED AS AN MI. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS CYPRESS STUDY PATIENT HAD A PERI-PROCEDURAL MI AND APPROXIMATELY 19 MONTHS POST INDEX DIED OF CARDIAC CAUSES AND STENT THROMBOSIS. THIS WAS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA (WITHIN PAST 6 WEEKS), FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PERIPHERAL ARTERY DISEASE, HISTORY OF HYPERLIPIDEMIA, AND SCLERODERMA. THE INDEX LESION WAS THE RCA, DESCRIBED AS DE NOVO, TYPE C AND 100% STENOTIC. THE LESION WAS PRE-DILATED WITH A TWO NON-CORDIS 2.5X20MM BALLOONS AT 12 ATMS. A DISSECTION WAS NOTED POST PRE-DILATION. TWO CYPHER STENTS WERE USED TO TREAT THE TARGET LESION AND THE DISSECTION. FIRST DEPLOYED WAS A 2.75X33MM CYPHER STENT AT 12 ATM. POST-DILATATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. IT WAS FOLLOWED BY A DEPLOYMENT OF A 3.0X33MM CYPHER STENT AT 12 ATMS, PROXIMAL TO THE PREVIOUS STENT IN AN OVERLAPPING IT. POST-DILATATION WAS PERFORMED WITH A 3.25X20MM BALLOON AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0% AND TIMI 3 FLOW WAS RESTORED. A SECOND TARGET LESION, 1ST OM WAS ALSO TREATED IN THE INDEX PROCEDURE. THIS LESION WAS DESCRIBED AS TYPE B AND 70% STENOTIC. A 3.5X23MM CYPHER STENT WAS DEPLOYED AT 12 ATMS BY DIRECT STENTING. POST-DILATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. IT WAS NOTED THAT THERE WAS ANTEGRADE FLOW IN THE 3RD OBTUSE MARGINAL BRANCH POST TREATMENT OF THE TWO INDEX LESIONS. THE DECISION WAS MADE TO TREAT THE LESION WITH POBA. POST-PROCEDURE TROPONIN I WAS TROPONIN I WAS 0.31 (TROPONIN I UPPER LIMIT 0.08 NG/ML). THE CEC COMMITTEE HAD ADJUDICATED THIS ELEVATION AS AN MI EVENT. THE PATIENT WAS DISCHARGED ON A DUAL ANTI-PLATELET REGIMEN. REPORT WAS RECEIVED THAT APPROXIMATELY 19 MONTHS POST PROCEDURE THE PATIENT HAD DIED OF UNKNOWN CAUSES. TO DATE NO FURTHER INFORMATION HAS BEEN AVAILABLE. THE CEC ADJUDICATION COMMITTEE HAS DETERMINED THE DEATH TO BE RELATED TO CARDIAC CAUSES AND STENT THROMBOSIS. THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO 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. 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. 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. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. 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. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00450, 3003742446-2011-00451 AND 3003742446-2011-00452.
THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT HAD ELEVATED CARDIAC ENZYMES POST PROCEDURE AND APPROXIMATELY 19 MONTHS POST INDEX DIED. THIS WAS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA (WITHIN PAST 6 WEEKS), FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PERIPHERAL ARTERY DISEASE, HISTORY OF HYPERLIPIDEMIA, AND SCLERODERMA. THE INDEX LESION WAS THE RCA, DESCRIBED AS DE NOVO, TYPE C AND 100% STENOTIC. THE LESION WAS PRE-DILATED WITH A TWO NON-CORDIS 2.5X20MM BALLOONS AT 12 ATMS. A DISSECTION WAS NOTED POST PRE-DILATION. TWO CYPHER STENTS WERE USED TO TREAT THE TARGET LESION AND THE DISSECTION. FIRST DEPLOYED WAS A 2.75X33MM CYPHER STENT AT 12 ATM. POST-DILATATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. IT WAS FOLLOWED BY A DEPLOYMENT OF A 3.0X33MM CYPHER STENT AT 12 ATMS, PROXIMAL TO THE PREVIOUS STENT IN AN OVERLAPPING IT. POST-DILATATION WAS PERFORMED WITH A 3.25X20MM BALLOON AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0% AND TIMI 3 FLOW WAS RESTORED. A SECOND TARGET LESION, 1ST OM WAS ALSO TREATED IN THE INDEX PROCEDURE. THIS LESION WAS DESCRIBED AS TYPE B AND 70% STENOTIC. A 3.5X23MM CYPHER STENT WAS DEPLOYED AT 12 ATMS BY DIRECT STENTING. POST-DILATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. IT WAS NOTED THAT THERE WAS ANTEGRADE FLOW IN THE 3RD OBTUSE MARGINAL BRANCH POST TREATMENT OF THE TWO INDEX LESIONS. THE DECISION WAS MADE TO TREAT THE LESION WITH POBA. POST-PROCEDURE TROPONIN I WAS TROPONIN I WAS 0.31 (TROPONIN I UPPER LIMIT 0.08 NG/ML). THE PATIENT WAS DISCHARGED ON A DUAL SNIT-PLATELET REGIMEN. REPORT WAS RECEIVED THAT APPROXIMATELY 19 MONTHS POST PROCEDURE THE PATIENT HAD DIED OF UNKNOWN CAUSES. TO DATE NO FURTHER INFORMATION HAS BEEN AVAILABLE. THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ELEVATED CARDIAC ENZYMES ARE A 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. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2011-00450, 3003742446-2011-00451 AND 3003742446-2011-00452.
POST-DILATATION WAS PERFORMED WITH A 3.25X20MM BALLOON AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0% AND TIMI 3 FLOW WAS RESTORED. PCI WAS PERFORMED NEXT ON A 70% DE NOVO LESION IN 1ST OBTUSE MARGINAL BRANCH OF 20MM IN LENGTH IN A 3.5MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS TYPE B2. A 3.5X23MM CYPHER STENT WAS DEPLOYED AT 12 ATM BY DIRECT STENTING. POST-DILATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. CORE LAB ANGIOGRAPHIC DATA OF THE RCA SHOWED THE BASELINE LESION MORPHOLOGY WAS PROXIMAL. THE LESION LENGTH WAS 25.69 MM, CONCENTRIC, BEND OF 55 DEGREES, THROMBUS ABSENT, NO ANEURYSM, INTIMAL FLAP ABSENT, PRE TIMI FLOW 0, POST-PROCEDURE, THROMBUS ABSENT, NO ANEURYSM, NO ABRUPT CLOSURE, NO REFLOW, NO DISSECTION, NO DISTAL EMBOLUS, PERFORATION ABSENT, SPASM ABSENT AND NO STENT FRACTURE. IN THE OM, BASELINE LESION MORPHOLOGY WAS PROXIMAL. THE LESION LENGTH WAS 15.77 MM, ECCENTRIC, BEND OF 50 DEGREES, THROMBUS ABSENT, NO ANEURYSM, INTIMAL FLAP ABSENT, PRE TIMI FLOW 0, POST-PROCEDURE, THROMBUS ABSENT, NO ANEURYSM, NO ABRUPT CLOSURE, NO REFLOW, NO DISSECTION, NO DISTAL EMBOLUS, PERFORATION ABSENT, SPASM ABSENT AND NO STENT FRACTURE. THE PATIENT HAD NO ANGINA SYMPTOMS DURING THE 1, 6, 12 AND 15 MONTH FOLLOW-UP INTERVALS. CONCOMITANT DEVICES: PRE-DILATATION TWO 2.5X20MM BALLOONS, 3.5X15MM BALLOON, 3.25X20MM, 2.75X33MM CYPHER, 3.0X33MM CYPHER AND 3.5X23MM CYPHER. CONCOMITANT MEDICATIONS: PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED BIVALIRUDIN. POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2011-00450, 3003742446-2011-00451 AND 3003742446-2011-00452.
THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT HAD ELEVATED CARDIAC ENZYMES POST PROCEDURE AND APPROXIMATELY 19 MONTHS POST INDEX DIED OF CARDIAC CAUSES AND STENT THROMBOSIS. THIS WAS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA (WITHIN PAST 6 WEEKS), FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PERIPHERAL ARTERY DISEASE, HISTORY OF HYPERLIPIDEMIA, AND SCLERODERMA. THE INDEX LESION WAS THE RCA, DESCRIBED AS DE NOVO, TYPE C AND 100% STENOTIC. THE LESION WAS PRE-DILATED WITH A TWO NON-CORDIS 2.5X20MM BALLOONS AT 12 ATMS. A DISSECTION WAS NOTED POST PRE-DILATION. TWO CYPHER STENTS WERE USED TO TREAT THE TARGET LESION AND THE DISSECTION. FIRST DEPLOYED WAS A 2.75X33MM CYPHER STENT AT 12 ATM. POST-DILATATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. IT WAS FOLLOWED BY A DEPLOYMENT OF A 3.0X33MM CYPHER STENT AT 12 ATMS, PROXIMAL TO THE PREVIOUS STENT IN AN OVERLAPPING IT. POST-DILATATION WAS PERFORMED WITH A 3.25X20MM BALLOON AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0% AND TIMI 3 FLOW WAS RESTORED. A SECOND TARGET LESION, 1ST OM WAS ALSO TREATED IN THE INDEX PROCEDURE. THIS LESION WAS DESCRIBED AS TYPE B AND 70% STENOTIC. A 3.5X23MM CYPHER STENT WAS DEPLOYED AT 12 ATMS BY DIRECT STENTING. POST-DILATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 3 FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. IT WAS NOTED THAT THERE WAS ANTEGRADE FLOW IN THE 3RD OBTUSE MARGINAL BRANCH POST TREATMENT OF THE TWO INDEX LESIONS. THE DECISION WAS MADE TO TREAT THE LESION WITH POBA. POST-PROCEDURE TROPONIN I WAS TROPONIN I WAS 0.31 (TROPONIN I UPPER LIMIT 0.08 NG/ML). THE PATIENT WAS DISCHARGED ON A DUAL SNIT-PLATELET REGIMEN. REPORT WAS RECEIVED THAT APPROXIMATELY 19 MONTHS POST PROCEDURE, THE PATIENT HAD DIED OF UNKNOWN CAUSES. TO DATE NO FURTHER INFORMATION HAS BEEN AVAILABLE. THE CEC ADJUDICATION COMMITTEE HAS DETERMINED THE DEATH TO BE RELATED TO CARDIAC CAUSES AND STENT THROMBOSIS. THE 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 15047076 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO EXCURSIONS WERE FOUND FOR LOT 15047076. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. PRE-STERILE LOT 15047079 WAS REVIEWED. IT WAS OBSERVED DURING REVIEW OF THIS LOT. (B)(4). NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED TO THE COATING SITE FOR DEATH AND THROMBOSIS IN DEVICE. THE INVESTIGATION REVEALED THAT NO NONCONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. ELEVATED CARDIAC ENZYMES ARE A 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. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. 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 INSIDE 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. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00450, 3003742446-2011-00451 AND 3003742446-2011-00452.
THE REPORT RECEIVED FROM THE (B)(6) STUDY THAT PER THE CORE LAB ANGIOGRAPHIC RESULTS, AFTER BALLOONING IN THE MID RCA WITH NON CORDIS BALLOONS DURING THE INDEX PROCEDURE, A DISSECTION OCCURRED THAT WAS SUCCESSFULLY RESOLVED WITH STENTING. ANOTHER LESION IN THE 1ST OBTUSE MARGINAL WAS TREATED AND AFTER THE 2 LESIONS WERE TREATED, IT WAS NOTED THAT THERE WAS ANTEGRADE FLOW IN THE 3RD OBTUSE MARGINAL BRANCH. THE DECISION WAS MADE TO TREAT THE LESION WITH BALLOONING. POST-PROCEDURE TROPONIN I WAS TROPONIN I WAS 0.31 (TROPONIN I UPPER LIMIT 0.08 NG/ML). NINTY MONTHS LATER, THE PATIENT DIED DUE TO UNKNOWN CAUSES. THE ORIGIN IS NOT KNOWN. DURING THE INDEX PROCEDURE, PCI WAS PERFORMED ON A 100% OCCLUDED DE NOVO LESION IN THE MID RCA OF 65MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS TYPE C WITH PRE-PROCEDURE TIMI FLOW OF 1. THE LESION WAS PRE-DILATED WITH A TWO 2.5X20MM BALLOONS AT 12 ATM AFTER WHICH THERE WAS A DISSECTION THAT WAS SUCCESSFULLY TREATED WITH THE 2 STENTS. FIRST DEPLOYED WAS A 2.75X33MM CYPHER STENT AT 12 ATM. POST-DILATATION WAS PERFORMED WITH A 3.5X15MM BALLOON AT 14 ATM. IT WAS FOLLOWED BY A DEPLOYMENT OF A 3.0X33MM CYPHER STENT AT 12 ATM, PROXIMAL TO THE PREVIOUS STENT IN AN OVERLAPPING IT.
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) | NA | 15047076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |