CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00457
- 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
.
VIRMANI ET AL IN STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE, JOURNAL OF CARDIOLOGY (2011) 58, 84-91. NAKAZAWA ET AL, CORONARY RESPONSES AND DIFFERENTIAL MECHANISMS OF ALAT STENT THROMBOSIS ATTRIBUTED TO FIRST-GENERATION SIROLIMUS AND PACLITAXEL-ELUTING STENTS, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2011) VOL 57,4, 390-398. THE PATIENT WAS TREATED IN THE UNITED STATES, BUT THE INFORMATION WAS PROVIDED IN AN ARTICLE WRITTEN BY A (B)(6) PHYSICIAN ASSOCIATED WITH THE STUDY AND WAS REPORTED VIA OUR (B)(4) AFFILIATES. THE DATE OF STENT IMPLANTATION WAS UNKNOWN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00457 AND 3003742446-2011-00458. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
ADDITIONAL INFORMATION WAS RECEIVED VIA THE SITE OF ONE OF THE AUTHORS ON (B)(4) 2011. THE LOT AND CATALOG NUMBERS WERE UNKNOWN, BUT BASED ON HIGH-DEFINITION X-RAY MEASUREMENT, THE SIZES OF THE STENTS WERE 3.5 X 28MM FOR THE MID LAD AND 3.5 X 23MM FOR THE PROXIMAL RCA. THE RCA STENT WAS IMPLANTED ON (B)(6) 2005 AND THE LAD STENT ON (B)(6) 2005. AT THE TIME OF FOLLOW-UP, THERE WAS NO APPARENT CALCIFICATION. THERE WAS NO RESTENOSIS, BUT LAD SHOWED OCCLUSIVE PLATELET-RICH THROMBUS AND RCA SHOWED NON-OCCLUSIVE ORGANIZED FIBRIN THROMBUS. THE CAUSE OF DEATH WAS VERY LATE STENT THROMBOSIS DUE TO HYPERSENSITIVITY REACTION. HISTOLOGY SHOWED MALPOSITION OF STENT STRUTS ASSOCIATED WITH HYPERSENSITIVITY REACTION IN BOTH LAD AND RCA. DUAL ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL) WERE DISCONTINUED 5 DAYS BEFORE THE SURGERY FOR MELANOMA. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00457 AND 3003742446-2011-00458. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY 24 MONTHS POST PROCEDURE, THERE WAS LATE STENT MALPOSITION, THROMBOSIS AND HYPERSENSITIVITY. THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011 IN FIGURE 2A. INFORMATION FOR THIS PATIENT WAS ALSO PRESENTED IN NAKAZAWA ET AL, CORONARY RESPONSES AND DIFFERENTIAL MECHANISMS OF LATE STENT THROMBOSIS ATTRIBUTED TO FIRST-GENERATION SIROLIMUS AND PACLITAXEL-ELUTING STENTS, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2011) VOL 57,4, 390-398 IN TABLE 6, PATIENT 2. THE TARGET LESIONS WERE IN THE LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY (RCA). THE LESIONS WERE A DE-NOVO, BUT OTHER LESIONS INFORMATION WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED VIA THE SITE OF ONE OF THE AUTHORS. THE LOT AND CATALOG NUMBERS WERE UNKNOWN, BUT BASED ON HIGH-DEFINITION X-RAY MEASUREMENT, THE SIZES OF THE STENTS WERE 3.5 X 28MM FOR THE MID LAD AND 3.5 X 23MM FOR THE PROXIMAL RCA. THE RCA STENT WAS IMPLANTED ON (B)(6) 2005 AND THE LAD STENT ON (B)(6) 2005. SEVENTEEN MONTHS AFTER THE IMPLANTATION, ASPIRIN AND CLOPIDOGREL HAD BEEN DISCONTINUED FOR FIVE DAYS AND THE PATIENT HAD UNDERGONE SURGICAL REMOVAL OF A MELANOMA (WIDE EXCISION). THE PATIENT SUFFERED LATE STENT THROMBOSIS, HYPERSENSITIVITY AND STENT MALPOSITION. AT THE TIME OF FOLLOW-UP, THERE WAS NO APPARENT CALCIFICATION. THERE WAS NO RESTENOSIS, BUT LAD SHOWED OCCLUSIVE PLATELET-RICH THROMBUS AND RCA SHOWED NON-OCCLUSIVE ORGANIZED FIBRIN THROMBUS. THE CAUSE OF DEATH WAS VERY LATE STENT THROMBOSIS DUE TO HYPERSENSITIVITY REACTION. HISTOLOGY SHOWED MALPOSITION OF STENT STRUTS ASSOCIATED WITH HYPERSENSITIVITY REACTION IN BOTH LAD AND RCA. DUAL ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL) WERE DISCONTINUED 5 DAYS BEFORE THE SURGERY FOR MELANOMA. THE STENTS REMAIN UNAVAILABLE FOR ANALYSIS. THERE WERE NO STERILE LOT NUMBERS AVAILABLE THUS NO DHR REVIEWS COULD BE PERFORMED. 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. HYPERSENSITIVITY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTATION OF DRUG ELUTING STENTS AND IS LISTED IN THE IFU AS SUCH. LOCALIZED REACTION TO THE DRUG ELUTING FROM THE STENT MAY CONTRIBUTE TO INFLAMMATION AND SCARRING AT THE TARGET LESION. VERY LATE 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. 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. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PATIENT, LESION AND VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.
THIS COMPLAINT WAS REPORTED IN "STENT THROMBOSIS OF DRUG ELUTING STENT: PATHOLOGICAL PERSPECTIVE"; JOURNAL OF CARDIOLOGY 58, 84-91, 2011 IN FIGURE 2A. INFORMATION FOR THIS PATIENT WAS ALSO PRESENTED IN NAKAZAWA ET AL, CORONARY RESPONSES AND DIFFERENTIAL MECHANISMS OF ALAT STENT THROMBOSIS ATTRIBUTED TO FIRST-GENERATION SIROLIMUS AND PACLITAXEL-ELUTING STENTS, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2011) VOL 57,4, 390-398 IN TABLE 6, PATIENT 2. THE TARGET LESIONS WERE IN THE LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY (RCA). THE LESIONS WERE A DE-NOVO, BUT OTHER LESIONS INFORMATION WAS UNKNOWN. ON AN UNKNOWN DATE, THE FIRST CYPHER (SIZE AND LOT UNKNOWN) WAS IMPLANTED AT THE LAD AND THE 2ND CYPHER (SIZE AND LOT UNKNOWN) WAS IMPLANTED AT THE RCA. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THESE IMPLANTS. SEVENTEEN MONTHS AFTER THE IMPLANTATION, ASPIRIN AND CLOPIDOGREL HAD BEEN DISCONTINUED FOR FIVE DAYS AND THE PATIENT HAD UNDERGONE SURGICAL REMOVAL OF A MELANOMA (WIDE EXCISION). FOUR DAYS LATER, WHILE ANTI-PLATELET WAS STILL DISCONTINUED, THE PATIENT SUDDENLY DIED DUE TO UNKNOWN CAUSE. AN AUTOPSY WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE 1ST CYPHER IMPLANTED AT THE LAD. HISTOPATHOLOGICAL WORK-UP WAS CONDUCTED AND TOTAL THROMBOTIC OCCLUSION AND DIFFUSE INFLAMMATION WERE OBSERVED AT THE SITE OF THE FIRST CYPHER IMPLANTED. NUMEROUS INFLAMMATORY CELLS WERE ALSO OBSERVED WITHIN THE NEOINTIMAL AREA. INFLAMMATORY REACTION PREDOMINANTLY CONSISTS OF T-LYMPHOCYTES AND EOSINOPHILS. INFLAMMATORY REACTION WAS ALSO OBSERVED IN THE SECOND CYPHER IMPLANTED AT THE RCA AND SEVERE INFLAMMATION RESULTED IN MALPOSITION OF STENT STRUTS. 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 | 40 YR | Death |