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

Catalog Number ZIV6-35-80-6.0-80-PTX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Occlusion (1984)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

12-011, study pt diagnosed with occlusion/restenosis within the 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 distal sfa, 60 mm in length.The lesion status was de novo with moderate calcification, thrombus, an occluded inflow tract, and three patent runoff vessels.The proximal reference vessel diameter (rvd) was 6 mm, the distal rvd was 6 mm with 100% diameter stenosis in study lesion.The lesion was pre-dilated with 30% 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) 2018 (839 days post-procedure), the patient was seen for a study follow-up clinical assessment.The study leg rutherford classification was two.The study lesion status was 70-99% stenosed.The patient was taking clopidogrel.The patient was diagnosed with an occlusion/restenosis requiring intervention within the study lesion.Treatment was planned for (b)(6) 2018.The clinical signs and symptoms were worsening claudication.The site indicated that the pre-existing condition of ¿evolution of the atherosclerosis artery¿ caused or contributed to the event.The physician indicated the event was definitely related to the study device.The device did not malfunction or deteriorate in characteristics or performance.On the same day, the patient completed and exited the study.No further information is available."as per complaint form": a ziv6-35-80-6.0-80-ptx has been implanted on (b)(6) 2018 on (b)(6) 2018), the patient was seen for a study follow-up clinica assessment.The study lesion status was 70-99% stenosed.The patient was taking clopidogrel.The patient was diagnosed with an occlusion/restenosis requiring intervention within the study lesion.Treatment was planned for (b)(6) 2018.The clinical signs and symptoms were worsening claudication.The physician indicated the event was definitely related to the study device.The device did not malfunction or deteriorate in characteristics or performance.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.Patient required intervention following restenosis.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Device evaluation: the ziv6-35-80-6.0-80-ptx device of lot number c1164259 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 ziv6-35-80-6.0-80-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 ziv6-35-80-6.0-80-ptx of lot number c1164259 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 c1164259.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 the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the information provided it is known that the patient had a history of coronary artery disease and is a current smoker.It is possible that these pre-existing conditions contributed to this event.As previously mentioned, restenosis of the stented artery is listed as a known potential adverse event within the ifu.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient underwent treatment for this event.However this information could not be provided to us as the patient had exited the study at the time when this was queried.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

12-011, study pt diagnosed with occlusion/restenosis within the 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 distal sfa, 60 mm in length.The lesion status was de novo with moderate calcification, thrombus, an occluded inflow tract, and three patent runoff vessels.The proximal reference vessel diameter (rvd) was 6 mm, the distal rvd was 6 mm with 100% diameter stenosis in study lesion.The lesion was pre-dilated with 30% 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) 2018 (839 days post-procedure), the patient was seen for a study follow-up clinical assessment.The study leg rutherford classification was two.The study lesion status was 70-99% stenosed.The patient was taking clopidogrel.The patient was diagnosed with an occlusion/restenosis requiring intervention within the study lesion.Treatment was planned for (b)(6) 2018.The clinical signs and symptoms were worsening claudication.The site indicated that the pre-existing condition of ¿evolution of the atherosclerosis artery¿ caused or contributed to the event.The physician indicated the event was definitely related to the study device.The device did not malfunction or deteriorate in characteristics or performance.On the same day, the patient completed and exited the study.No further information is available "as per complaint form": a ziv6-35-80-6.0-80-ptx has been implanted on (b)(6) 2018 on (b)(6) 2018), the patient was seen for a study follow-up clinica assessment.The study lesion status was 70-99% stenosed.The patient was taking clopidogrel.The patient was diagnosed with an occlusion/restenosis requiring intervention within the study lesion.Treatment was planned for (b)(6) 2018.The clinical signs and symptoms were worsening claudication.The physician indicated the event was definitely related to the study device.The device did not malfunction or deteriorate in characteristics or performance.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.Patient required intervention 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
• MDR Report Key: 9109640
• MDR Text Key: 161794051
• Report Number: 3001845648-2019-00490
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002552934
• UDI-Public: (01)10827002552934(17)170604(10)C1164259
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2017
• Device Catalogue Number: ZIV6-35-80-6.0-80-PTX
• Device Lot Number: C1164259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 83