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

Catalog Number ZISV6-35-125-6.0-60-PTX-C-CI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

13-002, 1370240, study pt with occlusion/restenosis prox to, within, distal to study lesion, possibly related to the study device.One study stent was placed during the index procedure on (b)(6) 2018, the study lesion was in the right distal sfa, 45 mm in length.There was 90 % stenosis in the study lesion noted on baseline angiography.The proximal reference vessel diameter (rvd) was 6.0 mm, the distal rvd was 6.0 mm.Pre-stent dilatation was performed with one inflation of a 6 mm x 40 mm balloon.The access site was contralateral.One study stent was placed without difficulty.Post stent dilatation was performed with two inflations of a 6 mm x 40 mm balloon.Final angiography measurements revealed 0% diameter stenosis in the study lesion.The patient was discharged on (b)(6) 2018.Discharge medications were aspirin and clopidogrel.On (b)(6) 2022 (1477 days post-procedure) the patient was contact by telephone for the four-year follow-up and indicated there had been no significant medical problems and has not been hospitalized since the last study contact.On (b)(6) 2022 (1526 days post-procedure), the patient was diagnosed with occlusion/restenosis proximal to, within, and distal to the study lesion.The patient presented with progressive claudication; no more information is known.The site indicated the event was possibly related to the study device, noting ¿occlusion within the study stent¿.Treatment included balloon angioplasty with both a bare and drug coated balloon.Date of discharge has not been reported.Investigators opinion on relationship to device: possibly related to the study device, noting ¿occlusion within the study stent¿.Investigators opinion on relationship to procedure: not related.Did the device malfunction or deteriorate in characteristics or performance: no no imaging was submitted with this event.The patient remains in the study.

Event Description

Supplemental follow-up report is being submitted due to the receipt of the image review related to this complaint on 09-feb-2023: impression: the complaint of right sfa and right sfa stent occlusion cannot be confirmed because imaging of the event was not provided.The ultrasounds demonstrated hemodynamically significant proximal sfa and in-stent stenosis progression that could have continued to the reported occlusion.

Manufacturer Narrative

Pma/510(k) #p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Device evaluation: the zisv6-35-125-6.0-60-ptx-c-ci device of lot number cf1310775 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.This complaint was opened to capture an occlusion/restenosis event observed with this study patient.This complaint is related to (b)(4) (mdr ref#3001845648-2023-00266) which was raised to capture the use of an expired device.The use of an expired device did not cause or contribute to the in stent restenosis.Lab evaluation the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review prior to distribution all zilver ptx drug-eluting peripheral stent devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.An nc was noted on the work but on review, it would not have contributed to this event.The review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.It should be noted that restenosis of the stented artery and occlusion are listed as known potential adverse events within the instructions for use (ifu0117).There is no evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comment was provided by the independent reviewer (ref att.(b)(4)_imaging review ver1'): impression 1.The complaint of right sfa and right sfa stent occlusion cannot be confirmed because imaging of the event was not provided.The ultrasounds demonstrated hemodynamically significant proximal sfa and in-stent stenosis progression that could have continued to the reported occlusion.Only 6-month, one year and two years data were provided but the complaint was related to sfa occlusion at 4.2 years.There was no 4.2 years post implantation images provided.Therefore, cri concluded that the stent occlusion cannot be confirmed.It was concluded that ¿the ultrasounds demonstrated hemodynamically significant proximal sfa and in-stent stenosis progression that could have continued to the reported occlusion (at 4.2 years)¿ based on 6-month, 1-year and 2-year data".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 that include a history of peripheral arterial disease, hypertension, hyperlipidemia and smoking (current).Restenosis of a stented artery and occlusion are listed as known potential adverse events within the ifu and are common adverse events of endovascular procedures that can be caused by obstruction to the vessel.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient remains in the study.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

A supplemental report is being submitted due to completion of the investigation on (b)(6)2023.

Manufacturer Narrative

Pma/510(k) # p100022/s014 supplier evaluation file in relation to xpedite ptx studies device evaluation the zisv6-35-125-6.0-60-ptx-c-ci device of lot number cf1310775 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.This complaint was opened to capture an occlusion/restenosis event observed with this study patient.This complaint is related to pr (b)(4) (mdr ref#3001845648-2023-00266) which was raised to capture the use of an expired device.The use of an expired device did not cause or contribute to the in stent restenosis.Lab evaluation the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review prior to distribution all zilver ptx drug-eluting peripheral stent devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.An nc was noted on the work but on review, it would not have contributed to this event.The review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.It should be noted that restenosis of the stented artery and occlusion are listed as known potential adverse events within the instructions for use (ifu0117).There is no evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comment was provided by the independent reviewer: impression 1.The complaint of right sfa and right sfa stent occlusion cannot be confirmed because imaging of the event was not provided.The ultrasounds demonstrated hemodynamically significant proximal sfa and in-stent stenosis progression that could have continued to the reported occlusion.Only 6-month, one year and two years data were provided but the complaint was related to sfa occlusion at 4.2 years.There was no 4.2 years post implantation images provided.Therefore, cri concluded that the stent occlusion cannot be confirmed.It was concluded that ¿the ultrasounds demonstrated hemodynamically significant proximal sfa and in-stent stenosis progression that could have continued to the reported occlusion (at 4.2 years)¿ based on 6-month, 1-year and 2-year data".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 that include a history of peripheral arterial disease, hypertension, hyperlipidemia and smoking (current).Restenosis of a stented artery and occlusion are listed as known potential adverse events within the ifu and are common adverse events of endovascular procedures that can be caused by obstruction to the vessel.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient remains in the study.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

A supplemental report is being submitted due to an update on the completion of the investigation on (b)(6) 2023.

• Brand Name: ZILVER PACLITAXEL-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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15801002
• MDR Text Key: 303703306
• Report Number: 3001845648-2022-00767
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2023

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 Catalogue Number: ZISV6-35-125-6.0-60-PTX-C-CI
• Device Lot Number: CF1310775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 10/19/2022; 10/19/2022; 10/19/2022
• Supplement Dates FDA Received: 03/09/2023; 06/30/2023; 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 82 KG