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 Problems Stenosis (2263); Surgical procedure, additional (2564)

Event Date 11/03/2014

Event Type  Injury  

Event Description

Patient is a (b)(6) male, diabetic but healthy/active and compliant, taking a regular dose of plavix.The procedure to implant zilver ptx stents was performed on (b)(6) 2013 based on claudication.His right leg was treated with 3 zilver ptx devices and a bare zilver on the proximal end.Stent fracture of one zilver pts stent was initially reported (reference related mdr report 3001845648-2014-00244) and a further zilver ptx stent fractures reported as a result of re-intervention performed on the (b)(6) 2014 (reference related mdr reports 3001845648-2014-00300 and 3001845648-2014-00299).It was also noted during the re-intervention procedure performed on the (b)(6) 2014 that in stent re-stenosis had occurred in one zilver ptx stent.This report addresses the in stent re-stenosis of one zilver ptx stent.The patient is doing well.The dr will most likely perform a bypass procedure int he next month or two but wanted to try stenting as a re-intervention initially.

Manufacturer Narrative

The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.To date image reviews have not been received relating to this event.It may be noted that re-stenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.As per instruction for use for zilver pts devices, restenosis of the stented artery is noted as a potential adverse event associated with the placement of this device.The complaint is confirmed based on customer testimony.As the rpn and lot number was no provided a review of the manufacturing records could not be performed.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Quality engineering will continue to monitor complaints of this nature 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 quiad, sr specialist ; 61334440
• MDR Report Key: 4317524
• MDR Text Key: 5136023
• Report Number: 3001845648-2014-00301
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P10022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR