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 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 two zilver ptx stent fractures were reported as a result of re-intervention performed on the (b)(6) 2014 (reference this report and related mdr report 3001845648-2014-003299.It is reported that the stent fractures were re-aligned with viabahn stent-grafts.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.(reference mdr report 3001845648-2014-00301).This report address stent fracture noted during re-intervention performed on the (b)(6) 2014.It is currently unknown which zilver ptx stent fractured.

Manufacturer Narrative

The patient is doing well.The dr will most likely perform a bypass procedure in the next month or two but wanted to try stenting as a re-intervention initially.As the device is implanted in the patient it is not available for evaluation; therefore a document based investigation was carried out.To date an image review relating to this event has not been received.To complaint as confirmed based on customer testimony.As there was no rpn or lot number 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.As per instruction for use for all zilver pts devices, stent strut fracture is noted as a potential adverse event associated with the placement of this device.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 quaid, sr specialist ; 613344440
• MDR Report Key: 4317529
• MDR Text Key: 5206603
• Report Number: 3001845648-2014-00300
• 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: Physician
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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