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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Reocclusion (1985); Claudication (2550); Surgical procedure, additional (2564)

Event Date 08/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2012: 3 zilver ptx stents, ziv6-35-125-6.0-120-ptx/c778568 x 1 (at distal side) + ziv6-35-125-6.0-120-ptx/c777375 x 1 (in the middle or at proximal side) + ziv6-35-125-6.0-40-ptx x 1 (in the middle or at proximal side) were placed from the right proximal sfa to pop.A (above-the-knee) with overlaps, approached from the left groin.Info received indicated that the pt had another manufacturer's stent (non-des) placed in the same lesion before.On (b)(6) 2014: approximately 75% of restenosis due to intimal hypertrophy was confirmed in the distal side of the ziv6-35-125-6.0-120-ptx/c778568 which was placed at the most distal side among the 3 stents.The user also reported that claudication had worsened.Pta (poba) was performed.On (b)(6) 2014: the pt had a favourable outcome.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).Incident meets the reporting criteria of an fda mdr report based on the surgical intervention carried out as a result of restenosis occurring in the distal side of the ziv6-35-125-6.0-120-ptx/c778568 which was placed at the most distal side among the 3 zilver ptx stents placed.The ziv6-35-125-6.0-120-ptx stent of lot number c778568 was implanted in the pt therefore is not available for evaluation.With the info provided a document based investigation was carried out.According to additional info provided for this complaint, a long lesion was listed as a factor that could have contributed to the event.Worsened claudication was listed as an adverse effect associated with the reported event.Additionally, in relation to this complaint the following comments were provided by the physician: "the restenosis was as mild as observed only in the distal side of one stent placed most distally among the 3 stents.I think it is not bad as a long-term clinical result.Regarding another manufacturer's non-des stent previously placed; i think it is unlikely that the bare metal stent related to the restenosis of ptx." it may be noted that restenosis 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 the leads to (or amplifies) the restenosis process.Worsened claudication indicated in the additional info form is the symptom of occlusive arterial disease and can be associated with reported restenosis.Based on the feedback provided by the physician, the reported restenosis was mild and this was considered as a good long-term clinical result.The long lesion was listed as a factor contributing to this event and therefore it is very unlikely that restenosis could have occurred due to zilver ptx malfunction.However, a definitive root cause of this stent restenosis cannot be determined.As no angiogram imaging was available to support the investigation, the complaint is confirmed based on customer testimony.As per instruction for use restenosis of the stented artery is noted as potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to info provided, pta (poba) was performed and the pt had a favourable outcome.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 ; 61334440
• MDR Report Key: 4254390
• MDR Text Key: 5046372
• Report Number: 3001845648-2014-00230
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P100022
• 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: 05/15/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C778568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/20/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2012
• 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: 58 YR