CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2010-01005
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Report Date
- December 9, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER
Narratives
THE DEVICE REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. PLEASE NOTE THE EVENT DATE IS UNKNOWN. THE CATALOG NUMBER IS UNKNOWN. THE DEVICE IS NOT DISTRIBUTED IN THE UNITES STATES, HOWEVER, IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT DISTRIBUTED IN THE UNITED STATES.
THE INFORMATION RECEIVED FROM A JOURNAL ARTICLE: DAVLOUROS PA, ET. AL., FLAT PANEL DIGITAL DETECTOR CINEFLUOROSCOPY LATE FOLLOWING SES OR BMS IMPLANTATION FOR DETECTION OF CORONARY STENT FRACTURE IN ASYMPTOMATIC PATIENTS, INT J CARDIOL (2010), DOI:10.1016/J.IJCARD.2010.11.002. (CASE 5) REPORTED THAT AT FOLLOW-UP 45.5+/- 15.7MONTHS POST STENTING WITH A CYPHER SIROLIMUS-ELUTING STENT (SES) A TYPE 2 STENT FRACTURE WITH 36% STENOSIS WAS OBSERVED IN THE ASYMPTOMATIC PATIENT. THERE WAS NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PERFORMED DURING THE FOLLOW UP. TYPE 2 FRACTURE WAS DEFINED AS INCOMPLETE TRANSVERSE STRUT FRACTURE RESULTING IN A V-SHAPED HORIZONTAL SEPARATION OF THE STRUTS WITHOUT DISCONTINUITY AT ONE EDGE OF THE STENT. THE ARTICLE INDICATED A MINIMAL LUMEN DIAMETER (MLD) OF 1.74, AND REFERENCE DIAMETER (RD) OF 3.07 POST IMPLANTATION, WITH A % STENOSIS POST IMPLANTATION OF 11. THE MLD AT FOLLOW-UP WAS 1.90 WITH A RD OF 2.99 AT FOLLOW-UP. PREDILATION WAS PERFORMED AT 12-14 ATM AND THE 3.5X18 CYPHER SELECT STENT (CRA18350/ I0205108) WAS DEPLOYED AT 18 ATM. THE INSTRUCTIONS FOR USE OUTLINES THAT THE RATED BURST IS 16 ATM. THE STENT WAS POST-DILATED AT 18 ATM. THE RESIDUAL STENOSIS WAS 0%. THE STENT WAS NOT IN A LOCATION WHERE THE VESSEL WAS INTRAMYOCARDIAL. THERE WAS NO DISSECTION. THE STATUS OF THE PATIENT IS OKAY. THE ARTICLE ALSO REPORTED THAT THE FRACTURED CYPHER STENTS OBSERVED IN THIS STUDY COMPARED TO THOSE THAT WERE NOT FRACTURED WERE LONGER STENTS MORE FREQUENTLY LOCATED IN THE RCA IN A LESION AND MORE FREQUENTLY LOCATED IN AN ANGLED AREA IN THE MIDDLE OF THE VESSEL AND OCCURRED MORE IN TYPE B2 AND C LESIONS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT I0205108 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FOUR UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NONCONFORMANCES: NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. IHT # (B)(4) WAS GENERATED BECAUSE THIS LOT PRESENTED A POINT OUT OF CONTROL IN 'U' GRAPHIC DUE TO WRINKLES IN SEAL. BASED IN THE INVESTIGATIONS PERFORMED THE ROOT CAUSE COULD NOT BE DETERMINED, ALL THE ASPECTS THAT COULD AFFECT THE QUALITY OF THE PRODUCT WERE FOUND WITHIN ESTABLISHED PARAMETERS. THE INVESTIGATION FOR THIS DEFECT WILL BE DIRECTED IN (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. A DHR REVIEW WAS REQUESTED TO NORMAN NOBLE INC. FOR PART NUMBER: (B)(4) STENT, LOT NUMBER: 4033744/4034325 AND THE RESULTS INDICATE THAT ALL STENTS SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. FACTORS THAT MAY CONTRIBUTE TO FRACTURES INCLUDE IMPLANTATION OF STENTS 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. 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 AVAILABLE INFORMATION, VESSEL/LESION CHARACTERISTICS RESULTING IN MECHANICAL STRESS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED; THE STENT WAS PRE-DILATED AT 12-14 ATM. THE TARGET LESION WAS THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO POSSIBILITY OF DISSECTION. THE STENT DEPLOYMENT PRESSURE WAS 18 ATM. THE STENT WAS POST-DILATED AT 18 ATM. THE RESIDUAL STENOSIS WAS 0%. THE STENT WAS NOT IN A LOCATION WHERE THE VESSEL WAS INTRAMYOCARDIAL. THE STATUS OF THE PATIENT IS OKAY.
THE INFORMATION RECEIVED FROM A JOURNAL ARTICLE: DAVLOUROS PA, ET. AL., FLAT PANEL DIGITAL DETECTOR CINEFLUOROSCOPY LATE FOLLOWING SES OR BMS IMPLANTATION FOR DETECTION OF CORONARY STENT FRACTURE IN ASYMPTOMATIC PATIENTS, INT J CARDIOL (2010), DOI:10.1016/J.IJCARD.2010.11.002, REPORTED THAT A PATIENT TREATED WITH A CYPHER SIROLIMUS-ELUTING STENT (SES) HAD A TYPE 2 STENT FRACTURE WITH 36% STENOSIS AT FOLLOW-UP. THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PERFORMED DURING THE FOLLOW UP.
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 | I0205108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |