CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2010-00967
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Report Date
- November 22, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT #9616099-2010-00967 AND 9616099-2010-00968.
REPORT OF A CYPHER BX STENT FRACTURE (B)(6) MONTHS POST IMPLANTATION OF TWO UNKNOWN SIZE CYPHERS WITH NO BINARY RESTENOSIS (DEFINED AS >50%) AT THE FRACTURE SITE WAS NOTED IN 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", YASUSHI INO, ET. AL, WAKAYAMA, JAPAN. THE LOCATION OF THE STENT FRACTURE WAS IS UNKNOWN. IT WAS INDICATED THAT THE CLINICAL OUTCOME WAS EVENT FREE. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA), BUT THE VESSEL 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 WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT PATIENTS WITH INAPPROPRIATE VESSEL SIZE WERE EXCLUDED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. AT INDEX PROCEDURE TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 39MM AND THE STENT DIAMETER WAS 3.0MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED (B)(6) MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE % DIAMETER STENOSIS (DS) WAS 27% AND POPMA ET AL CLASSIFICATION WAS III (COMPLETE SEPARATION WITHOUT DISPLACEMENT). THE SECOND FOLLOW UP ANGIOGRAM WAS PERFORMED (B)(6) MONTHS AFTER THE IMPLANT. THE % DS WAS 38% WITHOUT CLINICAL IMPACT. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. THE STUDY CONCLUDED THAT LATE RESTENOSIS WAS NOT OBSERVED IN STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS DURING THE MIDTERM FOLLOW-UP AFTER STENT IMPLANTATION. IT FURTHER REPORTED THAT CLOSE FOLLOW-UP SHOULD BE PERFORMED IN PATIENTS WITH STENT FRACTURE SINCE THE RISK OF VERY LATE STENT THROMBOSIS IN STENT FRACTURE SITES AFTER MIDTERM FOLLOW-UP IS STILL UNKNOWN. THE STENTS REMAIN IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE THE DEVICE HISTORY RECORDS REVIEW CANNOT BE COMPLETED. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS WITH OVERLAPPING STENTS AND 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 AND OVERLAPPING 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 REGARDING THE REPORTED EVENT; HOWEVER, PROCEDURAL AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2010-00967 AND 9616099-2010-00968.
ADDITIONAL INFORMATION RECEIVED (B)(4) 2011 INDICATED THAT ONLY 1 OF THE 2 STENTS WAS FRACTURED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT 9616099-2010-00967 AND 9616099-2010-00968.
CC UPDATED TO INCLUDE ADDITIONAL INFORMATION: THIS COMPLAINT IS FROM LITERATURE ARTICLE. 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 CASE IS 19TH OF 29 EVENTS. THE LITERATURE IS FROM (B)(6). THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA) BUT THE VESSEL 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 WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE STENT FRACTURE EVENT OCCURRED, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 39MM AND THE STENT DIAMETER WAS 3.0MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6~9MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RATE OF STENOSIS WAS 27% AND POPMA ET AL CLASSIFICATION WAS III (FRACTURED / SEPARATED). ADDITIONAL INFORMATION RECEIVED ON (B)(4), 2011 INDICATED THAT ONLY 1 OF THE 2 STENTS WAS FRACTURED. THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. STENT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CYPHER STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE CORONARY ARTERIES. THE CORONARY ARTERIES ARE VERY DYNAMIC VESSELS THAT UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT STENT FRACTURES OCCUR IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. THE CYPHER STENT WAS IMPLANTED TO TREAT INSTENT STENOSIS OF A PREVIOUSLY PLACED STENT. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT 9616099-2010-00967 AND 9616099-2010-00968.
ADDENDUM RECEIVED ON (B)(4) 2011: ONLY 1 OF THE 2 STENTS WAS FRACTURED.
THIS COMPLAINT IS FROM LITERATURE ARTICLE. 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 CASE IS 19TH OF 29 EVENTS. THE LITERATURE IS FROM (B)(6) HOSPITAL AND (B)(6) UNIVERSITY. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA) BUT THE VESSEL 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 WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 39MM AND THE STENT DIAMETER WAS 3.0MM. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED (B)(6) AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED, BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RATE OF STENOSIS WAS (B)(4) AND POPMA ET AL CLASSIFICATION WAS III (FRACTURED / SEPARATED).
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 | 64 YR | Hospitalization| L| R |