MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Device Problem Fracture (1260)

Patient Problem Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

The patient is a (b)(6) male, diabetic but healthy/active and complaint, taking a regular dose of plavix.The procedure for stent placement was performed (b)(6) 2013 based on claudication.His right leg was treated with a zilver ptx stent.The physician said that the patient's stent had fractured.Re-intervention was performed on the right side and the doctor will also perform a bypass in the next month or two.No further adverse effects to the patient have been reported as a result of this specific occurrence.The info received indicated the patient is doing well.

Manufacturer Narrative

Udi#: unk.The specific rpn of the device involved in this complaint is unk.The info provided indicated the device to be a zilver ptx.The device involved in this complaint remains implanted in the patient; therefore, will not be returned to cook ireland for evaluation.With the info provided a document based investigation was carried out.To data images have not been reviewed relating to this event.The customer complaint could be confirmed based on customer testimony.Zilver ptx drug eluting stent is the component involved in this complaint and undergoes inspection.A review of the relevant manufacturing records for zilver ptx and zilver ptx drug eluting stents could not be performed as the lot number of the complaint device was not provided.As per instructions for use ifu0093-4, it may be noted that stent fracture is a potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subjected to visual inspection and functional checks to ensure device integrity.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, senior specialist ; 61334440
• MDR Report Key: 4283403
• MDR Text Key: 5299174
• Report Number: 3001845648-2014-00244
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/24/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR