CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00456
- Event Type
- Death
- Date Received
- November 4, 2011
- Report Date
- October 12, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE OF ONE OF THE LITERATURE AUTHORS ON (B)(4) 2011. THE LOT AND CATALOG NUMBER OF THE STENT WAS UNKNOWN, BUT BASED ON THE HIGH-DEFINITION X-RAY MEASUREMENT, THE SIZE OF THE STENT WAS 2.5 X 18MM. THE TARGET LESION WAS IN THE PROXIMAL RAMUS INTERMEDIUS. AT THE TIME OF STENT FOLLOW-UP, THE LESION WAS MODERATELY CALCIFIED IN UNDERLYING PLAQUE AND HISTOLOGY SHOWED SEVERE IN-STENT RESTENOSIS (>75%). THE CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION IN NON-STENTED VESSEL (CIRCUMFLEX). HISTOLOGY SHOWED NO STENT MALPOSITION. IT WAS UNKNOWN IF THE PATIENT WAS ON ANTI-PLATELET THERAPY. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY 24 MONTHS POST PROCEDURE, THERE WAS RESTENOSIS WITH MI AND LATE STENT MALPOSITION LEADING TO DEATH. THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011. THE PATIENT WAS PRESENTED IN THE FIGURE3, C AND D. THE TARGET LESION AND LESION INFORMATION WERE ALL UNKNOWN. ON AN UNKNOWN DATE, A CYPHER (SIZE AND NUMBER OF UNIT WERE UNKNOWN) WAS IMPLANTED AT THE TARGET LESION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE OF ONE OF THE LITERATURE AUTHORS. THE LOT AND CATALOG NUMBER OF THE STENT WAS UNKNOWN, BUT BASED ON THE HIGH-DEFINITION X-RAY MEASUREMENT, THE SIZE OF THE STENT WAS 2.5 X 18MM. THE TARGET LESION WAS IN THE PROXIMAL RAMUS INTERMEDIUS. THIRTEEN MONTHS AFTER THE IMPLANTATION, THE PATIENT DIED DUE TO UNKNOWN CAUSE. AN AUTOPSY WAS CONDUCTED AND IN-STENT RESTENOSIS WAS OBSERVED UNDER A LOW POWER IMAGE. THERE WAS NO THROMBUS OBSERVED AT THE LESION THE CYPHER BX IMPLANTED. HISTOPATHOLOGICAL WORK-UP WAS CONDUCTED AND NECROTIC CORE FORMATION WITHIN THE INTIMAL TISSUE WAS OBSERVED. AT THE TIME OF STENT FOLLOW-UP, THE LESION WAS MODERATELY CALCIFIED IN UNDERLYING PLAQUE AND HISTOLOGY SHOWED SEVERE IN-STENT RESTENOSIS (>75%). THE CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION IN NON-STENTED VESSEL (CIRCUMFLEX). HISTOLOGY SHOWED NO STENT MALPOSITION. IT WAS UNKNOWN IF THE PATIENT WAS ON ANTI-PLATELET THERAPY. THE STENT REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE WERE NO STERILE LOT NUMBERS AVAILABLE THUS NO DHR REVIEWS COULD BE PERFORMED. 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. 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. IT IS UNKNOWN IF THE PATIENT WAS MAINTAINED ON A DUAL ANTI-PLATELET MEDICATION REGIMEN. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THROMBOTIC OR RESTENOSIS EVENTS WHEREIN THE INNER LUMEN OF THE CORONARY ARTERY BECOMES NARROWED AND BLOOD FLOW DECREASED. THE MYOCARDIAL TISSUES ARE STARVED OF OXYGEN AND OTHER NUTRIENTS SECONDARY TO THE DECREASED OR STOPPED BLOOD FLOW AND IT CAUSES PERMANENT CARDIAC DAMAGE. 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. STENT MALPOSITION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CYPHER STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU. 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. IT IS NOT KNOWN IF IVUS CONFIRMED COMPLETE APPOSITION OF THE STENTS OR IF THE STENTS WERE NOT COMPLETELY APPOSED TO THE INTIMAL SURFACE OF THE ARTERIAL WALL (INCOMPLETE STENT APPOSITION) DURING THE INDEX PROCEDURE. THERE IS A THEORETICAL CONCERN THAT INCOMPLETE STENT APPOSITION IN THE MIDDLE OF THE STENT CAN RESULT IN AREAS OF ''CUL-DE-SAC'' FORMATION WITH BLOOD-FLOW STAGNATION THAT CAN PREDISPOSE THE PATIENT TO STENT THROMBOSIS. SIROLIMUS HAS POTENT ANTI-INFLAMMATORY, IMMUNOSUPPRESSIVE, AND ANTIPROLIFERATIVE EFFECTS. THESE POTENT BIOLOGIC EFFECTS RAISE THEORETIC CONCERNS ABOUT POTENTIAL SIDE EFFECTS, SUCH AS INCOMPLETE HEALING, INCREASED THROMBOGENICITY, NECROSIS, APOPTOSIS, AND POSITIVE REMODELING. CONTINUED SURVEILLANCE AFTER DES IMPLANTATION IS REQUIRED TO DETERMINE THE LONG-TERM SAFETY. ANIMAL STUDIES HAVE SHOWN DELAYED ENDOTHELIALIZATION TO BE MORE COMMON IN OVERLAPPING STENT SEGMENTS THAN IN NON-OVERLAPPING STENT SEGMENTS FOR BOTH SIROLIMUS-ELUTING STENTS AND BARE METAL STENTS. 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 LESION, VESSEL AND PATIENT FACTORS MAY HAVE ALL CONTRIBUTED TO THE REPORTED EVENTS.
VIRMANI ET AL IN STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE, JOURNAL OF CARDIOLOGY (2011) 58, 84-91 THE PATIENT WAS TREATED IN THE UNITED STATES, BUT THE INFORMATION WAS PROVIDED IN AN ARTICLE WRITTEN BY A (B)(4) PHYSICIAN ASSOCIATED WITH THE STUDY AND WAS REPORTED VIA OUR (B)(4) AFFILIATES. THE DATE OF STENT IMPLANTATION WAS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011. THE PATIENT WAS PRESENTED IN THE FIGURE3, C AND D. THE TARGET LESION AND LESION INFORMATION WERE ALL UNKNOWN. ON AN UNKNOWN DATE, A CYPHER (SIZE AND NUMBER OF UNIT WERE UNKNOWN) WAS IMPLANTED AT THE TARGET LESION. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THIS IMPLANT. THIRTEEN MONTHS AFTER THE IMPLANTATION, THE PATIENT DIED DUE TO UNKNOWN CAUSE. AN AUTOPSY WAS CONDUCTED AND IN-STENT RESTENOSIS WAS OBSERVED UNDER A LOW POWER IMAGE. THERE WAS NO THROMBUS OBSERVED AT THE LESION THE CYPHER BX IMPLANTED. HISTOPATHOLOGICAL WORK-UP WAS CONDUCTED AND NECROTIC CORE FORMATION WITHIN THE INTIMAL TISSUE WAS OBSERVED. THERE WILL BE NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |