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

Catalog Number ZIV6-35-125-6.0-40-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Reocclusion (1985)

Event Date 02/18/2014

Event Type  Injury  

Event Description

On (b)(6) 2012, the complaint product was placed in the lower part of the right sfa, (b)(6) 2014 restenosis (50-99%) in the lesion where the complaint stent was implanted was confirmed.Ulcer and worsened claudication was observed to the pt.Removal of the blood clots and stent placement (misago/ terumo) were performed against this.The condition of the pt recovered.No further adverse effects to the pt have been reported as occurring.

Manufacturer Narrative

(b)(4).Incident meets criteria of an fda mdr report based on the intervention carried out (removal of the blood clots and stent placement) as a result of restenosis occurring while a zilver ptx stent was indwelling.The zilver ptx device involved in this complaint was implanted in the pt therefore, is not available for eval.With the info provided, a document based investigation was carried out.Add'l comment received from the physician is as follows: "although some blood clots were seen in the stenosed part, since intimal thickening was also observed there, we diagnosed that it was not in-stent thrombosis." it may be noted that re-stenosis is a common adverse event of endovascular procedures and can be reached by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response tha t leads (or amplifies) ot the restenosis process.As per instructions for use: worsened claudication and restenosis of the stented artery are noted as a potential adverse event associated with the placement of this device.Although requested images were not available to support the complaint investigation.A review of the mfg records for ziv6-35-125-6.0-40- ptx device and functional checks to ensure device integrity.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Since there are no images available for review, there is no evidence to suggest that re-stenosis did not occur; therefore the complaint is confirmed based on customer testimony.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 ; EI ; 61334440
• MDR Report Key: 4254391
• MDR Text Key: 5110183
• Report Number: 3001845648-2014-00226
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2014
• Device Catalogue Number: ZIV6-35-125-6.0-40-PTX
• Device Lot Number: C772689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2012
• 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: 78 YR