MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C08100MV

Device Problems Difficult or Delayed Positioning (1157); Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2014

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: it was reported that a 8x100 smart control stent could not cross through the left anterior descending artery lesion.(usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling).A gap was found on the tip of the stent.The delivery system was changed to another one to complete the procedure.There was no reported patient injury.One non-sterile pkg assy 8x100 smart (b)(4) was received coiled inside a plastic bag.The locking pin was observed in place.The unit was not deployed.The outer member distal tip was observed flayed.No more anomalies were found.Usable length was measured and was found acceptable.The outer diameter (od) of the outer sheath was measured and it was found acceptable.Functional test was performed, the stent could be deployed, and no anomalies were found.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The cause of the brite tip broken condition could not be conclusively determined; however it does not appear to be manufacturing related.Controls are in placed at the final assembly and packaging processes to detect these kind of issues.Handling and procedural factors could have contributed to this condition.The failures " stent delivery system (sds) failure to cross and deployment difficulty-premature/in patient¿ reported by the customer were not confirmed since during dimensional analysis the outer diameter was found within specification and the unit was received without deployment; additionally functional test was performed and no anomalies were found.The exact cause of the reported failure condition could not be conclusively determined.Neither the dhr review nor the product analysis suggests that the failure is related to the manufacturing process.Handling and procedural factors could be contributed to this condition.Therefore, no corrective actions will be taken.Based on the information available, it appears that the outer member distal tip flayed condition may have been caused by vessel characteristics or procedural factors and is not related to a product quality issue.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3682365
• MDR Text Key: 20477836
• Report Number: 9616099-2014-00193
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: C08100MV
• Device Lot Number: 15826190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 03/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1