CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2010-00958
- Event Type
- Injury
- Date Received
- December 16, 2010
- Report Date
- November 22, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
PLEASE NOTE, HAS BEEN CORRECTED TO REFLECT "SERIOUS INJURY." (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9 "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THIS LITERATURE IS FROM (B)(6) NATIONAL HOSPITAL AND (B)(6) MEDICAL UNIVERSITY. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS RIGHT CORONARY ARTERY (RCA) BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN IN-STENT RESTENOSIS (ISR) BUT IT WAS A CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, FOUR CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 94MM AND THE DIAMETER OF THE STENT WAS 3.0MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. AT THE FIRST FOLLOW-UP (6-9MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE %DS WAS 68% AND POPMA ET AL CLASSIFICATION WAS III. TO TREAT THE RESTENOSIS, CYPHER (DETAILS UNKNOWN) WAS IMPLANTED. AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS TO DETERMINE WHICH OF THE FOUR CYPHER STENTS WAS FRACTURED WERE UNSUCCESSFUL. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE AND THEREFORE ALL FOUR CYPHER STENTS WILL BE REPORTED WITH FRACTURE AND REOCCLUSION. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION, AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
(B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00959, 9616099-2010-00958, 9616099-2010-00957, AND 9616099-2010-00956. ADDITIONAL INFORMATION WAS RECEIVED REPORTING STENT FRACTURE WAS OBSERVED IN TWO OF THE FOUR STENTS. SINCE THE FRACTURE WAS OBSERVED IN ONLY TWO OF THE FOUR STENTS, THE STENT FRACTURE WILL BE CAPTURED IN (B)(4) (MDR REPORT 9616099-2010-00959) AND (B)(4) (MDR REPORT 9616099-2010-00958). OF THE TWO STENTS OBSERVED WITH STENT FRACTURE, RESTENOSIS WAS OBSERVED IN ONLY ONE OF THESE STENTS. THEREFORE, RESTENOSIS WILL ONLY BE CAPTURED IN (B)(4) (MDR REPORT 9616099-2010-00959). THE CODE RESTENOSIS WILL BE REMOVED FROM (B)(4) (MDR REPORT 9616099-2010-00958), (B)(4) (MDR REPORT 9616099-2010-00957), AND (B)(4) (MDR REPORT 9616099-2010-00956). IN ADDITION, THE CODE STENT FRACTURE WILL BE REMOVED FROM (B)(4) (MDR REPORT 9616099-2010-00957) AND (B)(4) (MDR REPORT 9616099-2010-00956). COMPLAINTS (B)(4) (MDR REPORT 9616099-2010-00957) AND (B)(4) (MDR REPORT 9616099-2010-00956) WILL BE UNREPORTED AS THEY WILL NO LONGER BE DEEMED MDR REPORTABLE. THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9 'SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION' THIS LITERATURE IS FROM WAKAYAMA NATIONAL HOSPITAL AND WAKAYAMA MEDICAL UNIVERSITY. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS RCA BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A CTO LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, FOUR CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 94MM AND THE DIAMETER OF THE STENT WAS 3.0MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. AT THE FIRST FOLLOW-UP (6~9 MONTHS AFTER THE IMPLANT) ANGIOGRAM, STENT FRACTURE AND RESTENOSIS WERE OBSERVED. STENT FRACTURE WAS NOTED IN TWO OF THE FOUR STENTS. THE RESTENOSIS WAS LOCATED IN ONLY ONE OF THE FRACTURE SITES AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE %DS WAS 68% AND POPMA ET AL CLASSIFICATION WAS III. TO TREAT THE RESTENOSIS, CYPHER (DETAILS UNKNOWN) WAS IMPLANTED. AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS TO DETERMINE WHICH OF THE FOUR CYPHER STENTS WAS FRACTURED WERE UNSUCCESSFUL. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE AND THEREFORE ALL FOUR CYPHER STENTS WILL BE REPORTED WITH FRACTURE AND REOCCLUSION. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
(B)(4). SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION. YASUSHI INO, MD, ET. AL. AM HEART J 2010;160:775.E1-775.E9. (B)(6) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THE ACTUAL EVENT DATE IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00959, 9616099-2010-00958, 9616099-2010-00957, AND 9616099-2010-00956.
THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9. "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THIS LITERATURE IS FROM (B)(6). THIS CASE IS 5TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS RCA BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A CTO LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, FOUR CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 94MM AND THE DIAMETER OF THE STENT WAS 3.0MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP (6 ~ 9MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE %DS WAS 68% AND POPMA ET AL CLASSIFICATION WAS III. TO TREAT THE RESTENOSIS, CYPHER (DETAILS UNKNOWN) WAS IMPLANTED. AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN
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 | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |