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

Catalog Number ZIV6-35-125-6.0-100-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Aspiration/Inhalation (1725); Thrombosis (2100); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

(b)(6) 2014 two ziv6-35-125-6.0-100-ptx stents were replaced in the right sfa by the right cfa approach after balloon pre-dilation.There was 5 cm distance between the two stents; one was placed in the sfa bifurcation and another was placed in the middle of the sfa.Around (b)(6) 2014 thrombotic occlusion was confirmed in the two stents.(b)(6) 2014, evt was performed for the thrombosis; approach was gained from the right brachial artery.Shuttle sheath (6fr.90 cm) was inserted and st.Jude medical's treasure xs was advanced.Thrombus aspiration was performed with goodman's rebirth, then poba was performed with a boston's sterling rx 4.0-4.0 and kaneka's jackal rx 5.0-80.After that, one terumo's misago 6.0-60 stent was additionally placed between the two ptx stents and another terumo misago 6.0-60 stent was additional placed in the distal side of the distal ptx stent.There have been no further adverse effects to the patient reported.As two zilver ptx devices are reported as involved in this event a separate report has been submitted for each device.Reference also related mdr report ref# 3001845648-2014-00322.

Manufacturer Narrative

The device involved in this complaint was implanted in the patient and was therefore not available for evaluation.With the information provided a document based investigation was carried out.As the device involved in this complaint was not returned for evaluation and conditions of use cannot be replicated in the laboratory, it is not possible to conclusively determine the root cause for this complaint.Arterial thrombosis is a known potential adverse effect associated with the placement of this device.The below list indicates potential risk factors that can generally contribute to the thromboses event: patient factors: history of coagulopathy/prior thrombosis (e.G., dvt), diabetes, especially if poorly controlled, cancer/chemotherapy, advanced age, obesity, hyperlipidemia, hypertension, smoking.Lesion factors: long lesion, small vessel diameter, severe calcification, lesion totally occluded prior to stent placement, placement for in-stent restenosis.Procedure factors: residual flow, outflow, or in-segment stenosis or dissection, poor run off (i.E., beyond trifurcation).Medication factors: inadequate procedural heparinization, inadequate loading dose of antiplatelet (ticlopidine or clopidogrel), inadequate dapt prescribed, non-responder to the apt, or non-compliant with prescribed regimen.According to the information provided the patient had the following known potential risk factors for thrombosis: hyperlipidemia, coronary artery disease, hypertension, uncontrolled diabetes.In addition there was a long lesion of 300 mm with a small degree of calcification prior to stent placement.An additional comment from the physician was received as follows" "i placed the ptx stents with no overlap but with approximately 5 cm distance between them.I assume that the event occurred maybe because the vessel where no stent was placed (approx.5 cm of space) had been injured during pre-poba during the procedure of initial ptx placement or mild stenosis had remained." as per the above feedback it can be stated that it is unlikely that stent thrombosis occurred due to zilver ptx malfunction.However, as there were no images available to support the complaint the root cause of the complaint cannot be conclusively determined.The complaint is confirmed based on customer testimony.A review of the manufacturing records revealed no discrepancies that could have contributed to this complaint.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Due to the lack of images no other comments can be provided at this time.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 ; cook ; EI ; 64334440
• MDR Report Key: 4346521
• MDR Text Key: 5202438
• Report Number: 3001845648-2014-00321
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Catalogue Number: ZIV6-35-125-6.0-100-PTX
• Device Lot Number: C907778
• Other Device ID Number: (01)10827002513447(17)150528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2013
• 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: 68 YR
• Patient Weight: 20