MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NONE

Catalog Number ZIV6-35-125-7-40-PTX

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 10/27/2014

Event Type  Injury  

Manufacturer Narrative

The zilver ptx device involved in this complaint is as follows: ziv6-35-125-7-40-ptx of lot number c990551 containing the zilver ptx drug eluting stent.The ptx stent involved in this complaint was implanted in the pt and was therefore, no available for eval.With the info provided, a document based investigation was carried out.Images relating to this event were requested, but have not been provided.The following info was provided in relation to this complaint."the physician does not know exactly whey the stents thrombosed but did mention that the pt potentially may have not been adequately anticoagulated." due to the lack of images, no further info can be provide at this time.The complaint was confirmed based on customer testimony.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.As per the instructions for use which accompanies this device, arterial thrombosis is noted as a potential adverse effect associated with the placement of this device.A review of the relevant mfg records for zilver drug eluting stents revealed no discrepancies that could have contributed to this complaint.As the stent involved in this complaint was not available for eval and condition of use cannot be replicated in a lab setting, it is not possible to conclusively determine the root cause for this complaint.Based on the info provided, no further adverse effects to the pt have been reported as occurring.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

The pt had two zilver ptx stents implanted on (b)(6) 2014.The implant procedure appeared to have gone well and the stents looked great at implant.On (b)(6) 2014, the pt came back to the hospital as both stents were acutely thrombosed.A second procedure was performed on (b)(6) 2014 with a laser to open up the stents.The physician does not know exactly why the stents thrombosed, but did mention that the pt potentially may have not been adequately anticoagulated.No further adverse effects to the pt have been reported as occurring.Ref also related report 3001845648-2014-00249.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NONE
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr., specialist ; EI ; 61334440
• MDR Report Key: 4283364
• MDR Text Key: 49743108
• Report Number: 3001845648-2014-00250
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248912
• UDI-Public: (01)10827002248912(17)141129(10)C990551
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2014
• Device Catalogue Number: ZIV6-35-125-7-40-PTX
• Device Lot Number: C990551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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