CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2013-00828
- Event Type
- Injury
- Date Received
- December 30, 2013
- Date of Event
- November 1, 2013
- Report Date
- December 10, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- OTHER
Narratives
PLEASE NOTE THAT THE DEVICE, AN UNKNOWN CYPHER SOLD OUTSIDE OF THE US FOR WHICH THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE, IS NOT SIMILAR TO THE US CYPHER. THEREFORE, ONLY THE MALFUNCTION MEETS THE CRITERIA FOR US REGULATORY REPORTING. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: (B)(4) , A. ET AL, FIVE-YEAR ANGIOGRAPHIC AND CLINICAL FOLLOW-UP OF PATIENTS WITH DRUG-ELUTING STENT IMPLANTATION FOR SYMPTOMATIC MYOCARDIAL BRIDGING IN ABSENCE OF CORONARY ATHEROSCLEROTIC DISEASE, THE JOURNAL OF INVASIVE CARDIOLOGY (2013) 25 (11) 586-592. PLEASE NOTE ALSO THAT THE GENDER OF THE PATIENT IS NOT KNOWN. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS NOTED IN THE PUBLICATION BY ERNST, A. ET AL, FIVE-YEAR ANGIOGRAPHIC AND CLINICAL FOLLOW-UP OF PATIENTS WITH DRUG-ELUTING STENT IMPLANTATION FOR SYMPTOMATIC MYOCARDIAL BRIDGING IN ABSENCE OF CORONARY ATHEROSCLEROTIC DISEASE, THE JOURNAL OF INVASIVE CARDIOLOGY (2013) 25 (11) 586-592; THE STUDY POPULATION CONSISTED OF 15 CONSECUTIVE NON-CAD PATIENTS (13 MEN AND 2 WOMEN) WITH SMB OF THE MID-PORTION OF THE LAD AND MINIMAL LUMINAL DIAMETER SYSTOLIC NARROWING OF THE TUNNELED SEGMENT OF =50% AND DIASTOLIC LUMINAL REDUCTION =20%, DETERMINED ON TWO ORTHOGONAL PROJECTIONS. ALL PATIENTS HAD MULTIPLE PREVIOUS HOSPITAL ADMISSIONS BECAUSE OF SYMPTOMS OF ANGINA, 1 HAD A HISTORY OF PREVIOUS NON-TRANSMURAL MI, AND 1 WAS ADMITTED TO THE HOSPITAL FOR NON-ST ELEVATION MI (NSTEMI). THREE-PATIENTS HAD IN-STENT RESTENOSIS (ISR) >50% WITHIN THE FIRST 3-6 MONTHS WHICH REQUIRED REPEAT REVASCULARIZATION WITH PLAIN OLD BALLOON ANGIOPLASTY (N=2) AND DRUG-ELUTING STENT IMPLANTATION (N=1). IN 1 PATIENT WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) CAUSED BY MYOCARDIAL BRIDGING, STENT IMPLANTATION WAS COMPLICATED WITH TYPE -3 CORONARY PERFORATION APPARENTLY CAUSED BY PARTIAL STRUT FRACTURE. QUICK-STENT GRAFT DEPLOYMENT AT 14 ATMOSPHERES (3.0X19MM JOSTENT GRAFTMASTER; ABBOT VASCULAR) INSTANTLY STOPPED INTRAPERICARDIAL BLEEDING AND PERMANENTLY SEALED OFF THE PERFORATION SITE PREVENTING THE IMMINENT CARDIAC TAMPONADE. FURTHER CLINICAL COURSE OF THE PATIENT WAS ENTIRELY UNEVENTFUL. IN ALL 3 PATIENTS, RESTENOSIS WAS FOCAL AND RANGED FROM 53%-60%. IN OUR PATIENT, PARTIAL STRUT FRACTURE, WHICH WAS PROBABLY INDUCED BY NON-UNIFORM STENT EXPANSION IN A HIGHLY MOBILE AND HARD BRIDGED SEGMENT AREA TOGETHER WITH A FORCEFUL BRIDGE CONTRACTION IN OPPOSITE DIRECTION TO BALLOON EXPANSION, RESULTED IN CORONARY PERFORATION. AFTER CAREFUL DETERMINATION OF THE BRIDGED SEGMENT LENGTH, PRIMARY STENTING WITH SIROLIMUS-ELUTING STENT (CYPHER OR CYPHER SELECT; CORDIS CORPORATION) WAS PERFORMED SO THAT THE STENT/STENTS EXTENDED AT LEAST 3 MM ON BOTH SIDES BEYOND VISIBLE BRIDGING INTO THE EPICARDIAL PORTION OF THE CORONARY ARTERY. INFLATION PRESSURES OF 12-14 ATM WERE USED DURING DES DEPLOYMENT. CALCULATED BALLOON-TO-ARTERY RATIO WAS 1.0. NO INTENTIONAL OVERSIZING WAS ATTEMPTED TO ACHIEVE MAXIMUM LUMINAL GAIN. USUALLY, STENT FRACTURE IS NOT RECOGNIZED AT THE TIME OF STENT PLACEMENT, BUT IS RATHER DIAGNOSED ON REPEAT ANGIOGRAPHY FOR ADVERSE OUTCOMES SUCH AS ISR. IN OUR PATIENT, STENT FRACTURE CAUSED INSTANTANEOUS PERFORATION, WHICH IS A VERY RARE COMPLICATION. THE ARTICLE CONCLUDED THE FOLLOWING: DES IMPLANTATION IN SELECTED PATIENTS WITH SMB UNRESPONSIVE TO OPTIMAL MEDICAL THERAPY IS AN EFFECTIVE AND FAIRLY SAFE THERAPEUTIC OPTION. IT PROVIDES SIGNIFICANT AND PERSISTENT LONG-TERM RELIEF OF SYSTOLIC AND DIASTOLIC LUMINAL REDUCTION AND CONCOMITANT MYOCARDIAL ISCHEMIA. HOWEVER, THERE IS A REMAINING ISSUE OF ISR AND TLR OF 18.7% (VERSUS 36% WITH BMS) WHICH, WE BELIEVE, MIGHT FURTHER IMPROVE IN THE FUTURE WITH THE USE OF NEWER-GENERATIONS DESS. NONETHELESS, THERE IS A SMALL BUT DEFINITE RISK OF CORONARY PERFORATION AT THE TIME OF STENT DEPLOYMENT WITHIN MB, WHICH IN OUR EXPERIENCE APPEARED IN 1 OF 16 STENTED VESSELS (6.3%). HOWEVER THE EXACT MECHANISM OF CORONARY PERFORATION MAY BE UNCLEAR AND COMPLEX; APPARENTLY, PARTIAL STENT FRACTURE MAY PLAY A MAJOR ROLE IN CERTAIN CASES. DUE TO THIS RARE, BUT REAL AND POTENTIALLY SERIOUS COMPLICATION, PATIENTS WILL NEED TO BE CHOSEN CAREFULLY AND PROVIDED WITH INDIVIDUALIZED TREATMENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO EXTENSIVE ANALYSIS COULD BE PERFORMED. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT PROVIDED, A DHR REVIEW COULD NOT BE COMPLETED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS AND IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, THE PARTIAL STRUT FRACTURE WAS PROBABLY INDUCED BY NON-UNIFORM STENT EXPANSION IN A HIGHLY MOBILE AND HARD BRIDGED SEGMENT AREA TOGETHER WITH A FORCEFUL BRIDGE CONTRACTION IN OPPOSITE DIRECTION TO BALLOON EXPANSION WHICH RESULTED IN CORONARY PERFORATION. WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS AND WITHOUT THE LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE STENT FRACTURE COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, THERE ARE VESSEL CHARACTERISTICS (MYOCARDIAL BRIDGING) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS AS DESCRIBED BY THE AUTHOR. THERE IS NO INDICATION THAT THE EVENTS MAY BE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS NOTED IN THE PUBLICATION BY (B)(4), A. ET AL, FIVE-YEAR ANGIOGRAPHIC AND CLINICAL FOLLOW-UP OF PATIENTS WITH DRUG-ELUTING STENT IMPLANTATION FOR SYMPTOMATIC MYOCARDIAL BRIDGING IN ABSENCE OF CORONARY ATHEROSCLEROTIC DISEASE, THE JOURNAL OF INVASIVE CARDIOLOGY (2013) 25 (11) 586-592; THREE-PATIENTS HAD IN-STENT RESTENOSIS (ISR) >50% WITHIN THE FIRST 3-6 MONTHS WHICH REQUIRED REPEAT REVASCULARIZATION WITH PLAIN OLD BALLOON ANGIOPLASTY (N=2) AND DRUG-ELUTING STENT IMPLANTATION (N=1). IN 1 PATIENT WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), STENT IMPLANTATION WAS COMPLICATED WITH TYPE -3 CORONARY PERFORATION WITH IMMINENT CARDIAC TAMPONADE, APPARENTLY CAUSED BY PARTIAL STRUT FRACTURE. QUICK-STENT GRAFT DEPLOYMENT AT 14 ATMOSPHERES (3.0X19MM JOSTENT GRAFTMASTER; ABBOT VASCULAR) INSTANTLY STOPPED INTRAPERICARDIAL BLEEDING AND PERMANENTLY SEALED OFF THE PERFORATION SITE. IN ALL 3 PATIENTS, RESTENOSIS WAS FOCAL AND RANGED FROM 53%-60%. IN OUR PATIENT, PARTIAL STRUT FRACTURE (FIGURE 2), WHICH WAS PROBABLY INDUCED BY NONUNIFORM STENT EXPANSION IN A HIGHLY MOBILE AND HARD BRIDGED SEGMENT AREA TOGETHER WITH A FORCEFUL BRIDGE CONTRACTION IN OPPOSITE DIRECTION TO BALLOON EXPANSION, RESULTED IN CORONARY PERFORATION (FIGURE 1). USUALLY, STENT FRACTURE IS NOT RECOGNIZED AT THE TIME OF STENT PLACEMENT, BUT IS RATHER DIAGNOSED ON REPEAT ANGIOGRAPHY FOR ADVERSE OUTCOMES SUCH AS ISR. IN OUR PATIENT, STENT FRACTURE CAUSED INSTANTANEOUS PERFORATION, WHICH IS A VERY RARE COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679243 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |