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

Catalog Number ZISV6-35-125-6.0-100-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.The zisv6-35-125-6.0-100-ptx device of lot number c1261618 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.There was another stent and complaint file linked to this occurrence.Refer to complaint file (b)(4) for the investigation details of the other device.From customer testimony, it is known that the device was used in a study, and the lesion had a rutherford classification of three.The patient was administered aspirin pre-procedurally.The customer was contacted to provide images of the implanted devices.The investigation will be updated once the images have been provided and reviewed.There is no evidence to suggest this event did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.From the information provided, it is known that the patient had risk factors for restenosis, including smoking and prior history of hypertension, hypercholesterolemia and atheromatous lesions, which the physician noted may have been a contributory factor.The patient exhibited a re-emergence of claudication, which could suggest a progression of the peripheral arterial disease in the proximal superficial femoral artery (sfa).However, as images of the device have not yet been provided, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.As per the product instruction for use, restenosis of the stented artery is listed under potential adverse effects.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.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1261618.From customer testimony, treatment for this event included further angioplasty.No other adverse effects were reported for the patient quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(6), occlusion possibly related to device.On (b)(6) 2016 during the index procedure the patient received two zilver© ptx© stents.The study lesion was in the right distal sfa and popliteal artery.The lesion status was de novo and there were no calcification or thrombus observed pre-procedure.The inflow tract was patient and there were three runoff vessels.The lesion length was 60 mm and the proximal and distal rvd were both 5 mm.The percentage diameter stenosis in study lesion was 100 %.A bare balloon angioplasty was performed prior to index procedure.Following pre-stent treatment the percentage diameter stenosis was 30 %.The post-procedure imaging showed 0 % diameter stenosis left in the study lesion.On (b)(6) 2017 (180 days post-procedure), the follow-up clinical assessment revealed a study leg rutherford classification of three.The study lesion status was patent but the maximum peak systolic velocity (psv) proximal to stented segment was 230 cm/sec and the percentage diameter stenosis was 70 %.The patient was still taking aspirin.An angioplasty was performed endovascularly in the study vessel due to persistent claudication and imaging evidence.The event was occlusion in the study lesion (including up to 5 mm proximal and/or distal to study lesion) and it was thought to be probably related to device and possibly related to procedure.A pre-existing condition of ¿multi-stage atheromatous lesions¿ was also noted as contributor to the event.(b)(4).

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6746845
• MDR Text Key: 81154281
• Report Number: 3001845648-2017-00304
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352848
• UDI-Public: (01)10827002352848(17)180613(10)C1261618
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-100-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/27/2017
• Date Device Manufactured: 08/12/2016
• 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: 52 YR
• Patient Weight: 46