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

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.

• Brand Name: UNKNOWN CYPHER US
• Type of Device: CORONARY 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 Key: 6482143
• MDR Text Key: 72438658
• Report Number: 1016427-2017-00256
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P020026
• Number of Events Reported: 1
• 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 Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CYPHER
• Device Catalogue Number: CYPHER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 03/15/2017
• Event Location: No Information
• Date Manufacturer Received: 03/15/2017
• 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