MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN CYPHER JAPAN; CORONARY DRUG-ELUTING STENT

Catalog Number CJSXXXX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The devices are cypher stents but the catalog and lot numbers are not available.Usui e, yonetsu t, kanaji y, hoshino m, yamaguchi m, hada m, hamaya r, kanno y, murai t, lee t, hirao k, kakuta t.Prevalence of neoatherosclerosis in sirolimus-eluting stents in a very late phase after implantation.Eurointervention 2018; jaa-443 2018, doi: 10.4244/eij-d-18-00486.As reported in the publication by usui, e.Et al., (2018).Prevalence of neoatherosclerosis in sirolimus-eluting stents in a very late phase after implantation.Eurointervention 2018; jaa-443; there were seventeen cases of stent malapposition at the 5 to 10 year follow-up.The products were not returned for analysis.No lot numbers were provided therefore product history record (phr) reviews could not be generated.The reported ¿stent underexpanded¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event, as calcified lesions may be resistant to stenting.According to the safety information in the instructions for use, ¿contraindications coronary artery stenting is generally contraindicated in the following patient types: patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.¿ according to the directions for use, which is not intended as a mitigation of risk, ¿under fluoroscopic visualization, inflate the balloon to deploy the stent but do not exceed the labeled rated burst pressure (16 atm).Optimal expansion requires the stent to be in full contact with the artery wall, with the stent internal diameter matching the size of the reference vessel diameter.Stent wall contact should be verified through routine angiography or intravascular ultrasound.¿ neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported in the publication by usui, e.Et al., (2018).Prevalence of neoatherosclerosis in sirolimus-eluting stents in a very late phase after implantation.Eurointervention 2018; jaa-443; there were seventeen cases of stent malapposition post cypher stent implantation at the 5 to 10 year follow-up.

• Brand Name: UNKNOWN CYPHER JAPAN
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863134823
• MDR Report Key: 8042140
• MDR Text Key: 128255601
• Report Number: 9616099-2018-02498
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CJSXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1