MAUDE Adverse Event Report: CORDIS DE MEXICO UNKPALMAZCORONARY; STENT, CORONARY

Model Number UNKPALMAZCORONARY

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

(b)(4).One palmaz stent was placed too low and lodged in one of the iliac limbs of a non-cordis aaa graft-stent.Nonetheless, it served its function well in correcting the proximal endoleak.

Manufacturer Narrative

As noted in the publication by law et al ¿effectiveness of proximal intra-operative salvage palmaz stent placement for endoleak during endovascular aneurysm repair¿, hong kong medical journal (2016 oct 24); doi: 10.12809/hkmj154799; one palmaz stent was placed too low and lodged in one of the iliac limbs of a non-cordis aaa graft-stent.Nonetheless, it served its function well in correcting the proximal endoleak.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 inaccurate placement¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors are unknown.The device was effective despite the incorrect positioning.According to the instructions for use ¿inspect crimped stent for uniformity, protruding struts, adherence to balloon, and centered placement in relation to the balloon marker bands.Do not reposition stent or hand-crimp.In case of a deviation, return product to cordis.Two radiopaque marker bands indicate the dilating section of the balloon.When the cordis large palmaz balloon-expandable stent and delivery system is introduced into the vascular system, it should be manipulated under high quality fluoroscopic observation.¿ neither the dhr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: UNKPALMAZCORONARY
• Type of Device: STENT, CORONARY
• 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 avenue; miami lakes, FL 33014
• MDR Report Key: 6142895
• MDR Text Key: 61711714
• Report Number: 9616099-2016-00778
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKPALMAZCORONARY
• Device Catalogue Number: UNKPALMAZCORONARY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2016
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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