MAUDE Adverse Event Report: CORDIS DE MEXICO UNKSTENT; CORONARY DRUG-ELUTING STENT

Model Number UNKSTENT

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Not Applicable (3189)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows lee et al (2016).Early coverage of drug-eluting stents analyzed by optical coherence tomography: evidence of the impact of stent apposition and strut characteristics on the neointimal healing process.There was one event of a malapposed (under-expanded) stent in a pig during baseline procedure for the cypher arm of the study.Clinical research coronary interventions.The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Event Description

As noted in the publication, early coverage of drug-eluting stents analyzed by optical coherence tomography: evidence of the impact of stent apposition and strut characteristics on the neointimal healing process.There was one event of a malapposed (under-expanded) stent in a pig during baseline procedure for the cypher arm of the study.

Manufacturer Narrative

Complaint conclusion: as noted in the publication, early coverage of drug-eluting stents analyzed by optical coherence tomography: evidence of the impact of stent apposition and strut characteristics on the neointimal healing process.There was one event of a malapposed (under-expanded) stent reported in a pig during baseline procedure for the cypher arm of the study.The product was not returned for analysis.No lot number was supplied therefore a device history record (dhr) review could not be generated.The reported ¿stent under-expanded¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors may have contributed to the reported event but are unknown.According to the instructions for use ¿under fluoroscopic visualization, inflate the balloon to at least the nominal pressure to deploy the stent, but do not exceed the labeled rated burst pressure of 16 atm (1621 kpa).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 dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.(b)(4).

• Brand Name: UNKSTENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenenue; miami lakes, FL 33014
• MDR Report Key: 6029612
• MDR Text Key: 57441545
• Report Number: 9616099-2016-00652
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKSTENT
• Device Catalogue Number: UNKSTENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/16/2016
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1