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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN CYPHER US CORONARY DRUG-ELUTING STENT

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CORDIS CORPORATION UNKNOWN CYPHER US CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number CYPHER
Device Problems Fracture (1260); Unintended Movement (3026)
Patient Problem Myocardial Infarction (1969)
Event Date 03/15/2017
Event Type  Injury  
Manufacturer Narrative
A cypher stent implanted in 2005 fractured in (b)(6) 2014. A migration occurred causing a heart attack. The product was not returned for analysis. No lot number was provided therefore a device history record (dhr) review could not be generated. The reported ¿stent fractured - in patient¿ and ¿stent migration¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics are unknown. As no lot number, catalogue code or other product information was supplied a dhr could not be completed. According to a review article ¿stents are more likely to fracture in the presence of the following factors: balloon or stent overexpansion, as it may theoretically weaken the stent struts; stent overlap, which results in localized rigidity creating hinge points that deform the stent leading to fracture; stent length: longer stents may be subjected to higher radial forces; inappropriate handling of stent; stenting technique: an example of stenting technique that might cause stent fracture is crush technique. A case has been reported of stent strut fracture in a bifurcation lesion treated with crush stenting, resulting in restenosis. Anatomic and pathologic factors which include the following: tortuous and highly angulated vessel; long lesions; change in vessel angulation after stent implantation, which can create a significant distortion force; complex lesions, as it was more frequent in the complex lesion subset of chronic total occlusion; stent location, as it is more common in right coronary artery (rca) and saphenous graft locations as these vessels are dynamic during cardiac contractions. Stents in these locations may be subjected to repetitive distorting forces, as some segments of these vessels have more flexion points during the cardiac cycle. Repetitive cardiac contraction exposes the stent to compression, torsion, kinking, elongation, bending, and shear stress, which can cause fracture from mechanical fatigue. The points of stent fractures are usually located at hinges subjected to either medial or shear forces created by non-uniform vessel anatomy. ¿ according to the instructions for use ¿adverse events (in alphabetical order) which may be associated with the implantation of a coronary stent in coronary arteries (may include); myocardial infarction, myocardial ischemia, occlusion, stent migration. ¿ the very limited information available does not suggest 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 by a caller, a cypher stent implanted in 2005 fractured on (b)(6) 2014. A migration occurred, causing a heart attack.
 
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Brand NameUNKNOWN CYPHER US
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
Manufacturer (Section G)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
Manufacturer Contact
cecil navajas
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6482143
MDR Text Key72438658
Report Number1016427-2017-00256
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P020026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYPHER
Device Catalogue NumberCYPHER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date03/15/2017
Event Location No Information
Date Manufacturer Received03/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2017 Patient Sequence Number: 1
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