CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00303
- Event Type
- Injury
- Date Received
- August 20, 2010
- Date of Event
- July 25, 2010
- Report Date
- July 26, 2010
- 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
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. 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 15110619 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
THE CEC MINUTES WERE RECEIVED AND THE ADJUDICATION AGREES WITH CLINICALLY DRIVEN TARGET LESION AND TARGET VESSEL PERCUTANEOUS INTERVENTION - RELATED TO DEVICE AND PROCEDURE. THIS WAS PREVIOUSLY CAPTURED AS CORONARY ARTERY RESTENOSIS FOR THE TWO CYPHER STENTS. ADDITIONALLY IT IS REPORTED IN THE ADJUDICATION MINUTES THAT AT INDEX PROCEDURE THE SECOND STENT WAS DEPLOYED TO TREAT OUTFLOW DISSECTION. THEREFORE, THE CODE OF DISSECTION WHICH WAS NOT INDICATED IN THE PROCEDURAL INFORMATION PREVIOUSLY RECEIVED WILL BE ADDED AND REPORTED AS RELATED TO THE 2.5X28MM CYPHER STENT. ALSO, ADDITIONAL INFORMATION FROM THE DATABASE STATED THAT THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI) THE DAY AFTER THE INDEX PROCEDURE. IT WAS NOTED THAT THE MI MAY HAVE BEEN CAUSED BY A SIDE BRANCH OCCLUSION. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
A PATIENT FROM THE (B)(4) STUDY HAD AN ARTERIAL SPASM AND HYPOPERFUSION DURING A PCI. APPROXIMATELY FOUR MONTHS POST IMPLANTATION OF TWO CYPHER STENTS, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDES CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS (17 YEARS), SMOKING WITHIN 30 DAYS, DEPRESSION AND ALLERGIC TO LATEX AND PENICILLIN. DURING THE INDEX PROCEDURE, A TYPE B LESION IN THE MID RCA WITH 70% STENOSIS WAS TREATED. THE LESION WAS 30MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE LESION WAS NOT PRE-DILATED BEFORE A 2.5X28MM CYPHER STENT WAS IMPLANTED IN THE MID RCA AT 18 ATM. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. ALTHOUGH THE LESION WAS ADEQUATELY TREATED, NON-SIGNIFICANT STENOSIS WAS NOTED DISTAL TO THE IMPLANTED STENT. AFTER THE WIRE WAS REMOVED, THE DISTAL STENOSIS APPEARED TO BE ABOUT 80% AND THE WIRE WAS RE-DELIVERED. HOWEVER, NEITHER A STENT NOR A BALLOON COULD BE DELIVERED BECAUSE THE WIRE WAS FELT TO BE UNDER THE STENT STRUTS OF THE PREVIOUSLY IMPLANTED STENT ACCORDING TO THE CATH LAB REPORT. ANOTHER WIRE WAS INSERTED BUT COULD NOT BE ADVANCED DUE TO CLOSING OF THE DISTAL RCA. INTRACORONARY NITROGLYCERINE WAS ADMINISTERED TO OPEN IT AND THE WIRE WAS DELIVERED SUCCESSFULLY. PRE-DILATION WAS CONDUCTED BEFORE A 2.25X13MM CYPHER STENT WAS IMPLANTED DISTALLY TO THE PREVIOUSLY IMPLANTED CYPHER AND OVERLAPPING IT WITH EXCELLENT RESULTS. THE RESIDUAL STENOSIS MEASURED 0%. THE PATIENT WAS DISCHARGED TWO DAYS LATER FROM THE HOSPITAL WITHOUT ANY ADVERSE EVENTS. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, AN ANGIOGRAPHY PERFORMED REVEALED THAT THE PREVIOUSLY TREATED MID-RCA SHOWED 90% IN-STENT RE-STENOSIS AND THE PROX-RCA SHOWED 70% STENOSIS. TO TREAT THE LESIONS, TWO XIENCE STENTS WERE IMPLANTED RESULTING IN 0% RESIDUAL STENOSIS. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. VESSEL SPASMS RESULTING IN HYPOPERFUSION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION. RESTENOSIS IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES), VESSEL/LESION FACTORS (SMALL VESSEL, LONG LESION) AND PROCEDURAL FACTORS (DIRECT STENTING, STENT DEPLOYMENT OVER RATED BURST PRESSURE) THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
A PATIENT FROM THE (B)(4) STUDY HAD AN ARTERIAL SPASM AND HYPOPERFUSION DURING A PCI. DURING TREATMENT OF THE MID RIGHT CORONARY ARTERY (RCA) LESION A 2.5 X 28MM CYPHER RX STENT WAS DIRECTLY IMPLANTED AT THE TARGET LESION AND POST-DILATED DUE TO INSUFFICIENT FLOW. A SECOND STENT, 2.25 X 13MM CYPHER RX, WAS DEPLOYED TO TREAT OUTFLOW DISSECTION. ADDITIONAL INFORMATION FROM THE DATABASE STATED THAT THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI) THE DAY AFTER THE INDEX PROCEDURE. IT WAS NOTED THAT THE MI MAY HAVE BEEN CAUSED BY A SIDE BRANCH OCCLUSION. THE SIDE BRANCH OCCLUSION IS LOCATED AT THE OVERLAPPING PORTION OF THE STENTS. APPROXIMATELY ONE MONTH POST PROCEDURE, THE PATIENT REPORTED CHEST PAIN AT REST WHICH RESOLVED SPONTANEOUSLY. HER ORAL DRUG THERAPY WAS INCREASED. THE SUBJECT WAS NOT RE-CATHETERIZED AT THIS TIME. THERE WAS NO DIAGNOSIS OF MI. APPROXIMATELY FOUR MONTHS POST IMPLANTATION OF TWO CYPHER STENTS, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDES CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS (17 YEARS), SMOKING WITHIN 30 DAYS, DEPRESSION AND ALLERGIC TO LATEX AND PENICILLIN. INITIALLY THE PATIENT WAS ADMITTED FOR STABLE ANGINA PECTORIS. THE PATIENT HAD STENOSIS OF THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS 30MM IN LENGTH AND WAS DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE PROXIMAL RCA SHOWED 50% STENOSIS AND THE MID-RCA SHOWED 70% STENOSIS. THE DISTAL-RCA SHOWED LUMINAL IRREGULARITIES. A 2.5 X 28MM CYPHER RX STENT WAS DIRECTLY IMPLANTED AT THE TARGET LESION AT 18ATM AND POST-DILATED DUE TO INSUFFICIENT FLOW. POST PROCEDURE STENOSIS WAS 0%. ALTHOUGH THE LESION WAS ADEQUATELY TREATED STENT STENOSIS WAS NOTED AT THE DISTAL MARGIN, BUT DID NOT APPEAR SIGNIFICANT. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. AFTER THE WIRE WAS REMOVED THE STENOSIS APPEARED TO BE 80%, THEREFORE A WIRE WAS CROSSED BACK INTO POSITION. NEITHER A STENT NOR A BALLOON COULD BE DELIVERED. THE WIRE COULD NOT BE ADVANCED 100% AND AT ONE POINT THE RCA CLOSED AT THE DISTAL SITE STENOSIS AND THIS WAS OPENED WITH INTRA-CORONARY NITROGLYCERINE AND THE WIRE WAS PLACED DISTALLY. ACCORDING TO THE CATH REPORT, THERE WAS NO DISSECTION. BALLOON ANGIOPLASTY WAS THEN PERFORMED AND A SECOND 2.25 X 13MM CYPHER RX STENT WAS IMPLANTED (ABUTTING) DISTALLY AT 17ATM AT THE SITE OF THE 80% DISTAL STENOSIS WITH EXCELLENT RESULTS. THE STUDY DATA INDICATED A RESIDUAL STENOSIS OF 0%. THE ANGIOGRAPHIC CORE LAB REPORTED A 20% FINAL RESIDUAL IN-LESION STENOSIS IN THE MID RCA WITH NO DISSECTION. IT WAS REPORTED THAT THE SECOND STENT WAS DEPLOYED TO TREAT OUTFLOW DISSECTION WITH GOOD RESULT. THE PATIENT WAS DISCHARGED TWO DAYS LATER FROM THE HOSPITAL WITHOUT ANY ADVERSE EVENTS. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, ANGIOGRAPHY PERFORMED REVEALED THAT THE PREVIOUSLY TREATED MID-RCA NEEDED TO BE REVASCULARIZED. THE PREVIOUSLY TREATED MID-RCA SHOWED 90% STENOSIS AND THE PROXIMAL RCA SHOWED 70% STENOSIS. THEREFORE TWO XIENCE STENTS WERE IMPLANTED RESULTING IN 0% RESIDUAL STENOSIS. ACCORDING THE CATH REPORT, THE PATIENT ALSO SHOWED STENOSIS OF THE OM1, RPDA AND RPLS NON-TARGET LESIONS DURING THIS TIME. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. VESSEL SPASMS RESULTING IN HYPOPERFUSION, SIDE BRANCH OCCLUSION AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION. THE IFU STATES THAT PLACEMENT OF A STENT HAS THE POTENTIAL TO COMPROMISE SIDE BRANCH PATENCY. THIS IS AN INHERENT RISK OF THE PROCEDURE. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ARE AT RISK TO CAUSE A SIDE BRANCH OCCLUSION. COMMON TECHNIQUES TO PREVENT OCCLUSIONS DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. RESTENOSIS IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES), VESSEL/LESION FACTORS (SMALL VESSEL, LONG LESION) AND PROCEDURAL FACTORS (DIRECT STENTING, STENT DEPLOYMENT OVER RATED BURST PRESSURE, AND RESIDUAL STENOSIS) THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. WITH REVIEW OF THE INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
ADDITIONAL INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATES THAT ON (B)(6) 2014 THIS PATIENT PRESENTED WITH MID STERNAL CHEST PAIN FOR 2 DAYS PRIOR TO ADMISSION. TROPONINS X 3 (B)(6), ELECTIVE CATHETERIZATION WAS DONE DUE TO HISTORY OF MULTIPLE ADMISSIONS FOR CHEST PAIN, (B)(6) 2013 NO PERFUSION DEFECTS ON STRESS TEST, AND WAS NOTED TO HAVE IN STENT RESTENOSIS MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED ON (B)(6) 2014 WITH A 2.25 X 14 RESOLUTE INTEGRITY DES AND 2.5X 28MM PROMUS PREMIER DES BOTH LISTED IN THE MID RCA. TIMI III FLOW POST STENTING AND 0% RESIDUAL STENOSIS. IN THE CATH REPORT FROM (B)(6) 2014 THE LEFT ANTERIOR DESCENDING (LAD) LESION WAS REPORTED AS DISCRETE (B)(6) STENOSIS. THE SUBJECT PRESENTED ON (B)(6) 2014 WITH CHEST PAIN FOR FOUR DAYS PRIOR TO ARRIVING IN ER. LEFT SIDED CHEST PAIN WITH GROCERY SHOPPING, RELIEVED BY REST. MULTIPLE EPISODES SINCE GROCERY SHOPPING NOT RELATED TO EXERTION. NORMAL EKG, (B)(6) TROPONINS X3. LAD DISCRETE (B)(6) STENOSIS WITH FFR 0.8, HAZY AND ECCENTRIC AND RCA STENTS PATENT. THE NEXT DAY A 3.0 X 16MM PROMUS PREMIER DES WAS PLACED IN THE PROXIMAL LAD. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
A PATIENT FROM THE CYPRESS STUDY HAD AN ARTERIAL SPASM AND HYPOPERFUSION DURING A PCI. DURING TREATMENT OF THE MID RIGHT CORONARY ARTERY (RCA) LESION A 2.5 X 28MM CYPHER RX STENT WAS DIRECTLY IMPLANTED AT THE TARGET LESION AND POST-DILATED DUE TO INSUFFICIENT FLOW. A SECOND STENT, 2.25 X 13MM CYPHER RX, WAS DEPLOYED TO TREAT OUTFLOW DISSECTION. ADDITIONAL INFORMATION FROM THE DATABASE STATED THAT THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI) THE DAY AFTER THE INDEX PROCEDURE. IT WAS NOTED THAT THE MI MAY HAVE BEEN CAUSED BY A SIDE BRANCH OCCLUSION. THE SIDE BRANCH OCCLUSION IS LOCATED AT THE OVERLAPPING PORTION OF THE STENTS. APPROXIMATELY ONE MONTH POST PROCEDURE THE PATIENT REPORTED CHEST PAIN AT REST WHICH RESOLVED SPONTANEOUSLY. HER ORAL DRUG THERAPY WAS INCREASED. THE SUBJECT WAS NOT RE-CATHETERIZED AT THIS TIME. THERE WAS NO DIAGNOSIS OF MI. APPROXIMATELY FOUR MONTHS POST IMPLANTATION OF TWO CYPHER STENTS, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. APPROXIMATELY 46 MONTHS AFTER THE INITIAL PROCEDURE, RESTENOSIS OF THE STUDY STENTS WAS IDENTIFIED AND WAS TREATED WITH NON CORDIS DRUG ELUTING STENTS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT¿S RISK FOR MACE INCLUDES CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS (17 YEARS), SMOKING WITHIN 30 DAYS, DEPRESSION AND ALLERGIC TO LATEX AND PENICILLIN. INITIALLY THE PATIENT WAS ADMITTED FOR STABLE ANGINA PECTORIS. THE PATIENT HAD STENOSIS OF THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS 30MM IN LENGTH AND WAS DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE PROXIMAL RCA SHOWED 50% STENOSIS AND THE MID-RCA SHOWED 70% STENOSIS. THE DISTAL-RCA SHOWED LUMINAL IRREGULARITIES. A 2.5 X 28MM CYPHER RX STENT WAS DIRECTLY IMPLANTED AT THE TARGET LESION AT 18ATM AND POST-DILATED DUE TO INSUFFICIENT FLOW. POST PROCEDURE STENOSIS WAS 0%. ALTHOUGH THE LESION WAS ADEQUATELY TREATED STENT STENOSIS WAS NOTED AT THE DISTAL MARGIN, BUT DID NOT APPEAR SIGNIFICANT. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. AFTER THE WIRE WAS REMOVED THE STENOSIS APPEARED TO BE 80%, THEREFORE A WIRE WAS CROSSED BACK INTO POSITION. NEITHER A STENT NOR A BALLOON COULD BE DELIVERED. THE WIRE COULD NOT BE ADVANCED 100% AND AT ONE POINT THE RCA CLOSED AT THE DISTAL SITE STENOSIS AND THIS WAS OPENED WITH INTRA-CORONARY NITROGLYCERINE AND THE WIRE WAS PLACED DISTALLY. ACCORDING TO THE CATH REPORT THERE WAS NO DISSECTION. BALLOON ANGIOPLASTY WAS THEN PERFORMED AND A SECOND 2.25 X 13MM CYPHER RX STENT WAS IMPLANTED (ABUTTING) DISTALLY AT 17ATM AT THE SITE OF THE 80% DISTAL STENOSIS WITH EXCELLENT RESULTS. THE STUDY DATA INDICATED A RESIDUAL STENOSIS OF 0%. THE ANGIOGRAPHIC CORE LAB REPORTED A 20% FINAL RESIDUAL IN-LESION STENOSIS IN THE MID RCA WITH NO DISSECTION. IT WAS REPORTED THAT THE SECOND STENT WAS DEPLOYED TO TREAT OUTFLOW DISSECTION WITH GOOD RESULT. THE PATIENT WAS DISCHARGED TWO DAYS LATER FROM THE HOSPITAL WITHOUT ANY ADVERSE EVENTS. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE ANGIOGRAPHY PERFORMED REVEALED THAT THE PREVIOUSLY TREATED MID-RCA NEEDED TO BE REVASCULARIZED. THE PREVIOUSLY TREATED MID-RCA SHOWED 90% STENOSIS AND THE PROXIMAL RCA SHOWED 70% STENOSIS. THEREFORE TWO XIENCE STENTS WERE IMPLANTED RESULTING IN 0% RESIDUAL STENOSIS. ACCORDING THE CATH REPORT, THE PATIENT ALSO SHOWED STENOSIS OF THE OM1, RPDA AND RPLS NON-TARGET LESIONS DURING THIS TIME. ADDITIONAL INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATES THAT APPROXIMATELY 4 YEARS AFTER THE STUDY IMPLANTATION, THIS PATIENT PRESENTED WITH MID STERNAL CHEST PAIN FOR 2 DAYS PRIOR TO ADMISSION. TROPONINS X 3 NEGATIVE, ELECTIVE CATHETERIZATION WAS DONE DUE TO HISTORY OF MULTIPLE ADMISSIONS FOR CHEST PAIN THE PRIOR MONTH WITH NO PERFUSION DEFECTS ON STRESS TEST, AND WAS NOTED TO HAVE IN STENT RESTENOSIS MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH A 2.25 X 14 RESOLUTE INTEGRITY DES AND 2.5X 28MM PROMUS PREMIER DES BOTH LISTED IN THE MID RCA. TIMI III FLOW POST STENTING AND 0% RESIDUAL STENOSIS. IN THE CATH REPORT FROM FEBRUARY THE LEFT ANTERIOR DESCENDING (LAD) LESION WAS REPORTED AS DISCRETE 50% STENOSIS. THE SUBJECT PRESENTED ONE MONTH LATER WITH CHEST PAIN FOR FOUR DAYS PRIOR TO ARRIVING IN ER. LEFT SIDED CHEST PAIN WITH GROCERY SHOPPING, RELIEVED BY REST. MULTIPLE EPISODES SINCE GROCERY SHOPPING NOT RELATED TO EXERTION. NORMAL EKG, NEGATIVE TROPONINS X3. LAD DISCRETE 60% STENOSIS WITH FFR 0.8, HAZY AND ECCENTRIC AND RCA STENTS PATENT. THE NEXT DAY A 3.0 X 16MM PROMUS PREMIER DES WAS PLACED IN THE PROXIMAL LAD. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. VESSEL SPASMS RESULTING IN HYPOPERFUSION, SIDE BRANCH OCCLUSION AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION. THE IFU STATES THAT PLACEMENT OF A STENT HAS THE POTENTIAL TO COMPROMISE SIDE BRANCH PATENCY. THIS IS AN INHERENT RISK OF THE PROCEDURE. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ARE AT RISK TO CAUSE A SIDE BRANCH OCCLUSION. COMMON TECHNIQUES TO PREVENT OCCLUSIONS DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. 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. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE CAN DISRUPT THE VESSEL PLAQUE AND INTIMA. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CALCIFICATION MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT MAY CONTRIBUTED TO THE EVENT, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. RESTENOSIS IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES), VESSEL/LESION FACTORS (SMALL VESSEL, LONG LESION) AND PROCEDURAL FACTORS (DIRECT STENTING, STENT DEPLOYMENT OVER RATED BURST PRESSURE, AND RESIDUAL STENOSIS) THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. WITH REVIEW OF THE INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE DATE OF THE PREVIOUSLY REPORTED RESTENOSIS EVENT OF (B)(6) 2014 WAS REVISED TO (B)(6) 2014. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. (B)(4). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER(S) IS/ARE 3003742446-2010-00303 AND 3003742446-2010-00304.
A PATIENT INITIALLY ENROLLED IN (B)(4) STUDY HAD CORONARY ARTERY SPASM, REVASCULARIZATION PERFORMED ON THE PREVIOUSLY TREATED TARGET LESION, INSUFFICIENT FLOW AND CORONARY ARTERY DISEASE PROGRESSION. INITIALLY, THE PATIENT WAS ADMITTED FOR STABLE ANGINA PECTORIS. THE PATIENT HAD STENOSIS OF THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS 30MM IN LENGTH AND WAS DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE PROXIMAL RCA SHOWED 50% STENOSIS AND THE MID-RCA SHOWED 70% STENOSIS. THE DISTAL-RCA SHOWED LUMINAL IRREGULARITIES. A 2.5 X 28MM CYPHER RX STENT WAS DIRECTLY IMPLANTED AT THE TARGET LESION AT 18ATM AND POST-DILATED DUE TO INSUFFICIENT FLOW. POST PROCEDURE STENOSIS WAS 0%. ALTHOUGH THE LESION WAS ADEQUATELY TREATED STENT STENOSIS WAS NOTED AT THE DISTAL MARGIN, BUT DID NOT APPEAR SIGNIFICANT. AFTER THE WIRE WAS REMOVED THE STENOSIS APPEARED TO BE 80%, THEREFORE A WIRE WAS CROSSED BACK INTO POSITION. NEITHER A STENT NOR A BALLOON COULD BE DELIVERED. THE WIRE COULD NOT BE ADVANCED 100% AND AT ONE POINT THE RCA CLOSED AT THE DISTAL SITE STENOSIS AND THIS WAS OPENED WITH IC NITRO AND THE WIRE WAS PLACED DISTALLY. ACCORDING TO THE CATH REPORT THERE WAS NO DISSECTION. BALLOON ANGIOPLASTY WAS THEN PERFORMED AND A SECOND 2.25 X 13MM CYPHER RX STENT WAS IMPLANTED (ABUTTING) DISTALLY AT 17ATM. THE PATIENT WAS DISCHARGED TWO DAYS LATER FROM THE HOSPITAL WITHOUT ANY ADVERSE EVENTS. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, ANGIOGRAPHY PERFORMED REVEALED THAT THE PREVIOUSLY TREATED RCA NEEDED TO BE REVASCULARIZED. THE PREVIOUSLY TREATED MID-RCA SHOWED 90% STENOSIS AND THE PROX-RCA SHOWED 70% STENOSIS. THEREFORE TWO XIENCE STENTS WERE IMPLANTED RESULTING IN 0% RESIDUAL STENOSIS. ACCORDING THE CATH REPORT, THE PATIENT ALSO SHOWED STENOSIS OF THE OM1, RPDA AND RPLS NON-TARGET LESIONS DURING THIS TIME.
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 | 15110619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| L| R |