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

Catalog Number ZIV6-35-125-6.0-60-PTX

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # : p100022/s001.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

On (b)(6) 2012: three of ziv6-35-125-6.0-60-ptx (c777742 x3) stent were placed on the patient's left below sfa.On (b)(6) 2017: occlusion in the area where stent were placed was confirmed.Rest pain and ulcer were confirmed on the patient.On (b)(6) 2017: pta was conducted against the restenosis and the condition of the patient recovered.

Manufacturer Narrative

Pma/510(k) # : p100022/s001.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113.Device evaluation three units of ziv6-35-125-6.0-60-ptx of lot number c777742 involved in this complaint were implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation ¿ n/a document review prior to distribution ziv6-35-125-6.0-60-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for ziv6-35-125-6.0-60-ptx of lot number c777742 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number.There is no requirement to take action as restenosis of the stented artery is listed as a known potential adverse event and can occur as a result of patient pre-existing conditions.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c777742.There is no evidence to suggest that the customer did not follow the instructions for use.However it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the ifu.The japanese packaging insert c-ci1202y06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patient¿s pre-existing conditions.From the information provided it is known that the patient had a medical history of hypertension, diabetes, hypercholesterolemia and had a history of smoking.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required percutaneous transluminal angioplasty (pta) as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

(b)(6) 2012: three of ziv6-35-125-6.0-60-ptx (c777742 x3) stent were placed on the patient's left below sfa.(b)(6) 2017: occlusion in the area where stent were placed was confirmed.Rest pain and ulcer were confirmed on the patient.(b)(6) 2017: pta was conducted against the restenosis and the condition of the patient recovered.

• 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
• MDR Report Key: 8802725
• MDR Text Key: 151442075
• Report Number: 3001845648-2019-00336
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513423
• UDI-Public: (01)10827002513423(17)140419(10)C777742
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

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 Expiration Date: 04/19/2014
• Device Catalogue Number: ZIV6-35-125-6.0-60-PTX
• Device Lot Number: C777742
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR