CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2010-00796
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- September 1, 2009
- Report Date
- September 20, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
Narratives
THE PATIENT UNDERWENT FOUR CORONARY ARTERY BYPASS GRAFT (CABG) ON (B)(6) 2010: LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD, SAPHENOUS VEIN GRAFT (SVG) TO INTERMEDIATE, SVG-TO OBTUSE MARGINAL (OM), SVG-PLV. THE ADMISSION DIAGNOSIS WAS THREE VESSEL DISEASE AND HYPERTENSION. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER THE SURGERY AND APPROXIMATELY ONE MONTH AFTER ADMISSION. THE PATIENT PROGRESSED ASYMPTOMATIC WITH NO SHORTNESS OF BREATH. THE PATIENT IS CURRENTLY WELL. EVENT DATE WAS REPORTED AS (B)(6) 2009, BUT DEFAULTS TO (B)(6) 2009. IMPLANT DATE IS (B)(6) 2007. A REPORT RECEIVED FROM MEDICAL AFFAIRS STATES THAT APPROXIMATELY TWENTY MONTHS AFTER IMPLANTATION OF A CYPHER SELECT + 3.00X28MM, THE PATIENT WAS INFORMED BY HIS DOCTOR THAT THE STENT HAD FRACTURED. THEN, THE PATIENT HAD A HEART BY-PASS OPERATION DONE TO AVOID THE RISK OF SUFFERING A HEART ATTACK. THE PATIENT IS AT HOME STILL RECOVERING. PRIOR TO STENT IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH ISCHEMIC HEART DISEASE AFTER AN EXERTIONAL STRESS TEST WAS POSITIVE AT STAGE 1. THE PATIENT HAD CHEST PAIN AND SHORTNESS OF BREATH. SUBSEQUENTLY, A CORONARY ANGIOGRAM SHOWED TRIPLE VESSEL DISEASE. ECHO SHOWED AN EJECTION FRACTION OF 52%. THE DISTAL RIGHT CORONARY ARTERY (RCA) TO POSTERIOR LEFT VENTRICULAR/POSTEROLATERAL (PLV) WAS STENTED WITH A 3.0 X 18MM CYPHER. TWO DAYS LATER, THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) WAS STENTED WITH A 3.0 X 28 MM CYPHER AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS DONE TO THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PATIENT WAS DISCHARGED FOUR DAYS LATER. THE PATIENT WAS WELL UNTIL A REPEAT ANGIOGRAM APPROXIMATELY TWENTY MONTHS LATER REVEALED THE FOLLOWING: A 70% DISTAL LEFT MAIN (LM), 70% OSTIAL AND 80% (SMALL CALIBER) LEFT CIRCUMFLEX (LCX), PATENT LAD STENT, AND 60% DISTAL RCA WITH QUESTIONABLE FRACTURE OF THE PREVIOUSLY IMPLANTED STENT. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) X4 TWO YEARS AND EIGHT MONTHS POST INDEX PROCEDURE. THE CABG INCLUDED: LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD, SAPHENOUS VEIN GRAFT (SVG) TO INTERMEDIATE, SVG-TO OBTUSE MARGINAL (OM), SVG-PLV. THE ADMISSION DIAGNOSIS WAS THREE VESSEL DISEASE AND HYPERTENSION. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER THE SURGERY AND APPROXIMATELY ONE MONTH AFTER ADMISSION. THE PATIENT PROGRESSED ASYMPTOMATIC WITH NO SHORTNESS OF BREATH. THE PATIENT IS CURRENTLY WELL. THE PATIENT'S MEDICAL HISTORY INCLUDED GASTRITIS, SLIDING HIATUS HERNIA, HYPERTENSION, DYSLIPIDEMIA AND WAS A SMOKER. THE CYPHER STENTS REMAIN IMPLANTED AND LOT NUMBERS OF THE CYPHER STENTS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. BASED ON THE LIMITED AVAILABLE CLINICAL AND PROCEDURAL INFORMATION, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS. HOWEVER, PATIENT, VESSEL AND PROCEDURAL FACTORS ALONG WITH PROGRESSION OF EXISTING CORONARY ARTERY DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED RESTENOSIS. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CABG. BASED ON THE LACK OF INFORMATION PERTAINING TO THE POSSIBLE FRACTURE OF THE STENT IN THE DISTAL RCA AND WITHOUT FILMS, NO DEFINITIVE CONCLUSION CAN BE MADE. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. TYPICALLY THE RIGHT CORONARY ARTERY (RCA) HAS MORE MOTION THAN OTHER CORONARY ARTERIES. LONGER STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE LIMITED PROCEDURAL INFORMATION IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION; HOWEVER, PATIENT, PROCEDURAL AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN.
PLEASE NOTE ADDITIONAL INFORMATION (CATALOG AND EXPIRATION DATE). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
A REPORT RECEIVED FROM MEDICAL AFFAIRS INDICATED THAT APPROXIMATELY TWO YEARS AND EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS INFORMED BY HIS DOCTOR THAT THE STENT HAS FRACTURED. THE PATIENT STATED THAT HE "HAD A HEART BY-PASS OPERATION DONE TO AVOID THE RISK OF SUFFERING A HEART ATTACK." PAST MEDICAL HISTORY INCLUDES GASTRITIS, SLIDING HIATUS HERNIA, HYPERTENSION, DYSLIPIDEMIA AND SMOKING. ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE PATIENT WAS INITIALLY DIAGNOSED WITH ISCHEMIC HEART DISEASE AFTER POSITIVE STRESS TEST. SUBSEQUENTLY, A CORONARY ANGIOGRAM CONDUCTED REVEALED TRIPLE VESSEL DISEASE. ECHO SHOWED AN EJECTION FRACTION OF 52%. THE DISTAL RIGHT CORONARY ARTERY (RCA) TO POSTEROLATERAL VESSEL (PLV) WAS STENTED WITH A 3.0 X 18MM CYPHER AT THIS TIME. A STAGED PROCEDURE WAS CONDUCTED TWO DAYS LATER AND THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) WAS STENTED WITH A 3.0 X 28 MM CYPHER AS WELL AS PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS CONDUCTED TO THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PATIENT WAS DISCHARGED FOUR DAYS LATER. APPROXIMATELY TWO YEARS AND EIGHT MONTHS AFTER THE INDEX AND STAGED PROCEDURES, A REPEAT ANGIOGRAM REVEALED THE FOLLOWING: LMS - DISTAL 70%, LCX - OSTIAL 70%, MID 80% (SMALL CALIBER), LAD - PATENT STENT, RCA - DISTAL 60%, QUESTIONED STENT FRACTURE OF PREVIOUS STENT. THE PATIENT UNDERWENT FOUR CORONARY ARTERY BYPASS GRAFT (CABG): LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD, SAPHENOUS VEIN GRAFT (SVG) TO INTERMEDIATE, SVG-TO OBTUSE MARGINAL (OM), SVG-PLV. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER THE SURGERY. THE PATIENT IS CURRENTLY WELL. TWO CD-ROMS OF THE INDEX PROCEDURE AND FOLLOW UP PROCEDURE WERE RECEIVED AND REVIEWED BY AN INDEPENDENT CARDIOLOGIST WHO NOTED THE FOLLOWING: "THE PATIENT HAD AN INITIAL ANGIOGRAM PERFORMED WHICH REVEALED MULTI-VESSEL DISEASE IN A PATIENT WITH SMALL CALIBER CORONARY ARTERIES. THE PATIENT HAD STAGE INTERVENTION WHICH INCLUDED THE LEFT ANTERIOR DESCENDING WITH A STENT, CIRCUMFLEX WITH A BALLOON ANGIOPLASTY AND THE RIGHT CORONARY INTO THE POSTERIOR LATERAL BRANCH WHERE A 3-0 X 18 CYPHER STENT WAS PLACED. OF NOTE, IT WAS ACROSS A BIFURCATION THAT HAD MODERATE ANGULATION AND THE PDA AROSE RIGHT AT THE MID-PORTION OF THE STENTED SEGMENT. THE PATIENT APPARENTLY DEVELOPED RECURRENT SYMPTOMS AND FOLLOW-UP ANGIOGRAM 32 MONTHS LATER REVEALED MULTI-VESSEL DISEASE AGAIN WITH POSSIBLE STENT FRACTURE AT THE MID-PORTION OF THE RIGHT CORONARY STENTED SEGMENT. THE PATIENT WAS SENT FOR BYPASS SURGERY AND HAD AN UNEVENTFUL RECOVERY. THIS PATIENT DID NOT EXHIBIT HEAVY CALCIFICATIONS. THE VESSELS IN THIS PATIENT WERE SOMEWHAT HYPER-MOBILE AND MODERATE ANGULATION WAS NOTED. THE PATIENT HAD AN APPARENT STENT FRACTURE IN THE MID-PORTION OF THE RIGHT CORONARY STENT WITH A MODERATE DEGREE OF IN-STENT RE-STENOSIS HOWEVER INTRAVASCULAR ULTRASOUND WAS NOT UTILIZED. THERE WAS MINIMAL SEPARATION OF THE FRACTURED SEGMENT. I BELIEVE THE MECHANICAL FACTORS ARE THE HYPER-MOBILITY OF THE VESSEL AND THE MODERATE ANGULATION MAY HAVE LEAD TO THE FRACTURE. IN ADDITION, THE SMALL VESSEL SIZE MAY HAVE ALSO PLAYED A ROLE AS THIS STENT DID APPEAR SLIGHTLY OVERSIZED FOR THE VESSEL." 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. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TYPE OF TREATMENT OF THE DISEASE PROCESS AND IT IS NOT A PREVENTION OR CURE OF THE PROGRESSION OF ATHEROSCLEROTIC ARTERY DISEASE. THERE ARE RISK FACTORS PRESENT IN THE MEDICAL HISTORY, SUCH AS DYSLIPIDAEMIA AND SMOKING, THAT MAY HAVE CONTRIBUTED TO THE PROGRESSION OF CARDIOVASCULAR DISEASE. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. TYPICALLY THE RIGHT CORONARY ARTERY (RCA) HAS MORE MOTION THAN OTHER CORONARY ARTERIES. LONGER STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, CABG IS A COMMON TREATMENT FOR PATIENTS WITH PROGRESSION OF MULTIVESSEL DISEASE. BASED ON THE FILM REVIEW, THERE ARE VESSEL FACTORS (HYPER-MOBILITY OF THE VESSEL AND THE MODERATE ANGULATION) AND POSSIBLE PROCEDURAL FACTORS (STENT APPEARED SLIGHTLY OVERSIZED FOR THE VESSEL SIZE) THAT MAY HAVE CONTRIBUTED TO THE STENT FRACTURE. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2010-00795 AND 9616099-2010-00796.
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THE DATE OF IMPLANT IS UNK OF THE MEDWATCH REPORT. THE STENT WAS IMPLANTED IN (B)(6) 2007. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2010-00795 AND 9616099-2010-00796.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT WAS DIAGNOSED WITH ISCHEMIC HEART DISEASE IN 2007 AFTER AN EXERTIONAL STRESS TEST WAS POSITIVE AT STAGE 1. THE PATIENT HAD CHEST PAIN AND SHORTNESS OF BREATH. SUBSEQUENTLY, A CORONARY ANGIOGRAM SHOWED TRIPLE VESSEL DISEASE. ECHO SHOWED AN EJECTION FRACTION OF 52%. THE DISTAL RIGHT CORONARY ARTERY (RCA) TO POSTEROLATERAL VESSEL (PLV) WAS STENTED WITH A 3.0 X 18MM CYPHER ON (B)(6) 2007. ON (B)(6) 2007, THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) WAS STENTED WITH A 3.0 X 28 MM CYPHER AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS DONE TO THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PATIENT WAS DISCHARGED FOUR DAYS LATER. DISCHARGE DIAGNOSIS: THREE VESSEL DISEASE POST-STENTING OVER THE LAD AND RCA. THREE VESSEL DISEASE STAGE PCI. PCI TO THE LAD (STENTED AND CYPHER). BALLOON TO LCX. THE PATIENT WAS WELL UNTIL (B)(6) 2009. A REPEAT ANGIOGRAM REVEALED THE FOLLOWING: LMS - DISTAL 70%, LCX - OSTIAL 70%, MID 80% (SMALL CALIBER), LAD - PATENT STENT, RCA - DISTAL 60%, QUESTIONED STENT FRACTURE OF PREVIOUS STENT.
A REPORT RECEIVED FROM (B)(6) STATES A PATIENT HAD A CYPHER SELECT + 3.00X28MM IMPLANTED IN (B)(6) 2007. APPROXIMATELY TWENTY MONTHS AFTER THE INDEX PROCEDURE THE PATIENT WAS INFORMED BY HIS DOCTOR THAT THE STENT HAS FRACTURED. THEN, THE PATIENT HAD A HEART BY-PASS OPERATION DONE TO AVOID THE RISK OF SUFFERING A HEART ATTACK. THE PATIENT IS AT HOME STILL RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | 13268182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | CYPHER SELECT + 3.00X18MM |