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

Catalog Number ZIV6-35-125-6.0-40-PTX

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022.Device evaluation: the ziv6-35-125-6.0-40-ptx device of lot number c1184555 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.Document review: prior to distribution ziv6-35-125-6.0-40-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 ziv6-35-125-6.0-40-ptx of lot number c1184555 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1184555.It should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0063-6).There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that 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.A possible root cause could also be attributed to patient pre-existing conditions.From the information provided it is known that the patient had a medical history of coronary artery disease, hypertension, hypercholesterolemia, type ii diabetes and cancer.It is possible that theses pre-existing conditions may have contributed to this event.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required endovascular angioplasty and stent placement as a result of this occurrence.The patient completed and exited the study.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

12-011, study pt with occlusion/restenosis within & distal to study lesion & in a non-study lesion ¿definitely¿ r/t study device.One zilver© ptx© stent was placed during the index procedure on (b)(6) 2016.The study lesion was in the left proximal sfa, 30 mm in length.The lesion status was de novo with no calcification or thrombus.The inflow tract was 50-99% stenosed and there was one patent runoff vessel.The proximal reference vessel diameter (rvd) was 7.0 mm, the distal rvd was 5.8 mm with 85% diameter stenosis in study lesion.The lesion was pre-dilated with 20% diameter stenosis in study lesion remaining.There were no difficulties during the procedure and there was no residual stenosis at the completion of the procedure.The patient was discharged on (b)(6) 2016.On (b)(6) 2017 (519 days post-procedure), the patient was diagnosed with an occlusion/restenosis requiring intervention.The location of the occlusion/restenosis was the proximal superficial femoral intrastent occlusion, the medial and distal sfa stenosis, with multifocal stenosis of the popliteal artery.The clinical signs and symptoms were persistent claudication.Treatment included endovascular angioplasty and stent placement.The physician indicated the event was definitely related to the study device, and the pre-existing condition of ¿other intervention¿ caused or contributed to the event.The device did not malfunction or deteriorate in characteristics or performance.On (b)(6) 2018 (794 days post-procedure), a follow-up clinical visit was completed.The study leg rutherford classification was 0, the study lesion was patent.The patient was taking aspirin and clopidogrel.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.The patient required endovascular angioplasty and stent placement following restenosis.

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 9172322
• MDR Text Key: 161812859
• Report Number: 3001845648-2019-00515
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513416
• UDI-Public: (01)10827002513416(17)171014(10)C1184555
• 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: Other
• Type of Report: Initial
• Report Date: 09/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2017
• Device Catalogue Number: ZIV6-35-125-6.0-40-PTX
• Device Lot Number: C1184555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• 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: 80 YR
• Patient Weight: 76