MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Fracture (1260)

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

Event Date 11/03/2014

Event Type  Injury  

Event Description

This event has been reported under mdr report ref#3001845648-2014-00301.Two zilver ptx stent fractures had been initially reported (reference related mdr reports 3001845648-2014-00300 & 3001845648-2014-00299).It is reported that the stent fractures were re-aligned with viabahn stent-grafts.It was noted during this re-intervention procedure performed on the (b)(6) 2014 that in stent re-stenosis had occurred in one zilver ptx stent.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 are-intervention initially.Mdr report ref# 3001845648-2014-00301 and this report address the report of in stent restenosis.The lot numbers for the zilver ptx stents used in this case were c929367 and c929365.Only one stent had restenosis issues, but it could not be confirmed which of the two lots were affected.Therefore a separate report is submitted for each suspect lot.

Manufacturer Narrative

The 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.Two zilver ptx stent fractures have been reported (reference related mdr reports 3001845648-2014-00300 and 3001845648-2014-00299).It is reported that the stent fractures were re-aligned with viabahn stent-grafts.It was noted during this re-intervention procedure performed on the (b)(6) 2014 that in stent re-stenosis had occurred in one zilver ptx stent.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 are-intervention initially.Mdr report ref# 3001845648-2014-00301 and this report address the report of in stent restenosis.The lot numbers for the zilver ptx stents used in this case were c929367 and c929365.Only one stent had restenosis issues, but it could not be confirmed which of the two lots were affected.Therefore a separate report is submitted for each suspect lot.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.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 instructions for use restenosis of the stented artery is noted as a potential adverse event associated with the placement of this device.Images relating to this event were received and reviewed as follows: findings: four images photographed by an (b)(6) from an angiography monitor are provided.The first is a larger field of view image of a mid-right superficial femoral artery zilver ptx stent including its overlap with adjacent stents.A long segment of the more inferior stent is also imaged.The image demonstrates a step-off involving the medial proximal side of the mid stent.One or two stent apices are displaced towards the vessel lumen.The stent apices remain parallel to the lumen and the stent.Focal areas of calcified atheroma are present.One is just superior the displaced apices.The second image is a magnified version of the first.The third image according to the complaint report demonstrates a stent fracture proximal the depicted overlap.No fracture is detectable on the image.This is possibly a function of poor image quality.Densely calcified atheroma is just medial the overlap.The fourth image angiographically demonstrates nee-intimal hyperplasia through a 40mm long stent segment centered at the inferior overlap and reported second stent fracture site.A stent fracture is not imaged.The lumen is diffusely narrowed 50% maximal diameter.Impression: a type 1 stent fracture is possible in the proximal medial mid stent.Alternatively two stent apices could be displaced by the vessel wall into the lumen without fracture.The second reported stent fracture cannot be confirmed on the provided imaging.Nee-intimal hyperplasia is present.Given the diffuse distribution, the second stent fracture even if present was not an aggravating factor.The long stented length increased the restenosis risk.According to the independent image review the fourth image provided demonstrated nee-intimal hyperplasia through a 40mm long stent segment.The lumen is diffusely narrowed 50% maximal diameter.The tong stented length increased the restenosis risk.However, the root cause of this restenosis cannot be conclusively determined.The complaint is confirmed based on customer testimony.A review of the manufacturing records revealed no discrepancies related to this complaint issue.Prior to distribution, all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Quality engineering assessed the complaint and the risk has been determined to be low.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING 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 ; 61334440
• MDR Report Key: 4370123
• MDR Text Key: 5234731
• Report Number: 3001845648-2014-00335
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C929365
• Other Device ID Number: 01108270022489051713110110C929
• 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
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• 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