MAUDE Adverse Event Report: CORDIS CORPORATION CYPHER SIROLIMUS-ELUTING CORONARY STENT; DRUG-ELUTING STENT (NIQ)

Catalog Number CYPHEROUS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

As reported by jung-sun et al serial randomized comparison of strut coverage of everolimus- and first-generation sirolimus-eluting stents; canadian journal of cardiology (2015) 723-730; there were 23 cases of stent malapposition after the procedure and at the 3-month follow-up in the cypher arm of the study.This study was a prospective, randomized, open-label, 2 2 factorial designed single-centre trial.Each patient was assigned to either type of des and intensity of statins.A total of 60 patients who fulfilled the inclusion criteria and were willing to undergo serial oct follow-up examinations were included in this trial, which was performed between (b)(6) 2011 and (b)(6) 2013.Each patient was randomly assigned into either the ees or first-generation ses (cypher) group.The ees was the target des in this study, and the first-generation ses was selected as an active comparator.Serial oct examinations were performed at 3 time points, including immediately after the procedure, and at 3 and 12 months after the procedure.Patients were 20 years old with stable or unstable angina and non-st-elevation myocardial infarction.Patients were visually examined and deemed eligible for participation if they were considered to be candidates for percutaneous coronary intervention (pci) of a de novo lesion with a reference vessel diameter of 2.5-3.5 mm, a stenosis diameter 70%, and a stent length 24 mm.Exclusion criteria were: (1) st elevation myocardial infarction or hemodynamically unstable status; (2) complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main coronary artery diseases, chronic total occlusion, in-stent restenosis, and vein-graft lesion); (3) des treatment within the preceding 6 months; (4) serum creatinine level 2.0 mg/dl or existence of end-stage renal disease; (5) contraindication to receiving antiplatelet agents; (6) left ventricular ejection fraction < 35%; (7) pregnant women or women of child-bearing potential; and (8) life expectancy < 1 year.This randomized study was approved by our institutional review board, and written informed consent was obtained from all enrolled patients.Randomization and study procedures study patients who fulfilled the enrollment criteria were randomly assigned in a 1:1 ratio to receive either an ees (n = 30) or a first-generation ses (n = 30), and either atorvastatin 40 mg (n = 29) or pravastatin 20 mg (n = 31) (2 2 design) using a concealed interactive web-based response system.To preserve a balance between the 2 des groups, stratified randomization was performed according to the estimated length and diameter of the implanted des.All patients received at least 75 mg aspirin and a loading dose of 300 mg clopidogrel at least 12 hours before pci.Unfractionated heparin was administered to maintain an activated clotting time of > 250 seconds.All pci procedures were performed according to current standard techniques.Treatment after the procedure included a 12-month prescription for dual antiplatelet therapy with 100 mg aspirin and 75 mg clopidogrel daily.Quantitative coronary angiography analysis was performed before and after stent implantation and at 3- and 12-month follow-ups using an off-line quantitative coronary angiographic system (caas system; pie medical instruments, maastricht, netherlands) in an independent core laboratory (cardiovascular research center, seoul, korea).Patients were examined immediately after the procedure and at 3 and 12 months after the procedure.Basically, preintervention oct examination was not mandatory and additional poststent balloon dilation was performed using angiography guidance.The primary end point was the percentage of uncovered struts for ees and first-generation ses implants in 12-month follow-up oct images.The secondary end points were the percentage of uncovered struts for ees and first-generation ses implants in 3-month follow-up oct images, and the percentage of uncovered struts in the 3-month vs 12-month follow-up samples.Clinical follow-up was performed at 1, 3, 6, 9, and 12 months after pci.All clinical events such as death, myocardial infarction, or repeated revascularization were monitored.Late-acquired stent malapposition was detected in 4 ses cases (15.4%) but not in any ees cases at the 12-month follow-up.Most of the stent struts were covered at 3 months and 12 months after everolimus-eluting stent implantation.The uncovered struts were frequently observed at 3 months and persisted until at least 12 months in sirolimus-eluting stent-treated lesions.

Manufacturer Narrative

(b)(6).One mdr report is being submitted for multiple patients (a quantity of 23 events) with no patient demographics or device specifics.This complaint was found during a recent literature search of this device.The citation is as follows: kim et al (2015, june).Serial randomized comparison of strut coverage of everolimus- and first-generation sirolimus-eluting stents, canadian journal of cardiology 31, 723-730.This is the initial and final report for this event.Complaint conclusion: as reported by jung-sun et al., serial randomized comparison of strut coverage of everolimus and first-generation cypher stents; canadian journal of cardiology (2015) 723-730.This study consisted of a total of 60 patients who fulfilled the inclusion criteria and were willing to undergo serial optimal coherence tomography (oct) follow-up examinations between (b)(6) 2011 and (b)(6) 2013.Each patient was randomly assigned into either the everolimus-eluting stent (ees) or the cypher stent group.Basically, pre-intervention oct examination was not mandatory and additional post-stent balloon dilation was performed using angiography guidance.There were 23 cases of stent malapposition after the procedure and at the 3-month follow-up in the cypher arm of the study.The product was not returned for evaluation and a review of the manufacturing records could not be conducted without lot numbers.The reported ¿stent - underexpanded¿ event could not be confirmed since the product was not returned.The exact cause of the failure could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

• Brand Name: CYPHER SIROLIMUS-ELUTING CORONARY STENT
• Type of Device: DRUG-ELUTING STENT (NIQ)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4929281
• MDR Text Key: 6052802
• Report Number: 9616099-2015-00312
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CYPHEROUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNFRACTIONATED HEPARIN