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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022.(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

This report is being submitted based on stent migration in 2018/2019.On (b)(6) 2017 i had a procedure for pad.Dr.Implanted cook¿s zing ptx paclitaxel - a pad device stent.Ever since then i had an ongoing side effects, medical problems and complications.Following the procedure i had humongous reaction, i spent 3 days in the hospital in excruciating pain and my leg was unrecognizable.My other leg and my hands were also exhibiting swelling and rash.After that for months i was in continuous pain and my leg was swollen.I had a throbbing pain in the area were the stents were from groin to the knee.In (b)(6) i was admitted to the hospital, the stent/stents were clogged.They tried clot busters but it did not work.They then tried to open the artery with balloon which also did not work, and i developed another severe reaction with red spots all over my leg and the leg swelled even more.This is in (b)(6) hospital.After a couple of months i decided to go see a vascular specialist in (b)(6) hospital in (b)(6).My leg hurt and was getting very cold and pale.From the beginning, i keep telling the doctors it¿s the stents giving me the problem.I did some research on the internet and found out the that paclitaxel is a chemotherapy drug for cancer patients.That's when i found out that i have chemotherapy drugs in my system.No one asked my permission to put this stent in.Now i have 2, 10cm each long stents in my right leg.Another blockage occured and i had to have another procedure in (b)(6) 2018.They treated me with clogbusters, unsuccessful.Then they reopened the stent.After that my knee started hurting very bad.I went to ortho dr.He took the x-ray of the front of my knee and the side of my knee.When i had the stent put in my leg cardiologist always showed me that 1st stent is from groin then there is a little space and then second stent is to above the knee.On the xray it showed that the stent was bent and it was below and behind my knee.Did the stent move? from the beginning i am feeling my body rejecting the stents.Now the fda has started worrying about mortality risk if patients with these stents and/or balloons treated with paclitaxel for treatment of pad.This drug may increase my risk of death in the 2nd of 5th year after procedure.What is next? why is this happening? since this company came up with this device they must have some answers how to get the stents out.I know the drug is already in my system but how long is it active.Intravenous paclitaxel for cancer has half life about 6 hours, while paclitaxel crystals for pad takes weeks to months.Does the company have any idea of how long? is there any way to cleanse my system of the drugs? i really need some answers.

Event Description

This report is being submitted based on stent migration in 2018/2019.On (b)(6) 2017 i had a procedure for pad.Dr.Implanted cook¿s zing ptx plactitaxel - a pad device stent.Ever since then i had an ongoing side effects, medical problems and complications.Following the procedure i had humongous reaction, i spent 3 days in the hospital in excruciating pain and my leg was unrecognizable.My other leg and my hands were also also exhibiting swelling and rash.After that for months i was in continuous pain and my leg was swollen.I had a throbbing pain in the area were the stents were from groin to the knee.In july i was admitted to the hospital, the stent/stents were clogged.They tried clot busters but it did not work.They then tried to open the artery with balloon which also did not work, and i developed another severe reaction with red spots all over my leg and the leg swelled even more.This is in cu auszultz hospital.After a couple of months i decided to go see a vascular specialist in yale new haven hospital in ct.My leg hurt and was getting very cold and pale.From the beginning, i keep telling the doctors it¿s the stents giving me the problem.I did some research on the internet and found out the that paclitaxel is a chemotherapy drug for cancer patients.That's when i found out that i have chemotherapy drugs in my system.No one asked my permission to put this stent in.Now i have 2, 10cm each long stents in my right leg.Another blockage occured and i had to have another procedure in (b)(6) 2018.They treated me with clogbusters, unsuccessful.Then they reopened the stent.After that my knee started hurting very bad.I went to (b)(6) dr.He took the x-ray of the front of my knee and the side of my knee.When i had the stent put in in my leg cardiologist always showed me that 1st stent is from groin then there is a little space and then second stent is to above the knee.On the xray it showed that the stent was bent and it was below and behind my knee.Did the stent move? from the beginning i am feeling my body rejecting the stents.Now the fda has started worrying about mortality risk if patients with these stents and/or balloons treated with paclitaxel for treatment of pad.This drug may increase my risk of death in the 2nd of 5th year after procedure.What is next? why is this happening? since this company came up with this device they must have some answers how to get the stents out.I know the drug is already in my system but how long is it active.Intravenous paciltaxile for cancer has half life about 6 hours, while pactitaxel crystals for pad takes weeks to months.Does the company have any idea of how long? is there any way to cleanse my system of the drugs? i really need some answers.

Manufacturer Narrative

Pma/510(k) #: p100022 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 it should be noted that there are four other investigations related to this file.For details of the other investigations please refer to (b)(4).The zisv6 device of unknown lot number 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.Lab evaluation ¿ n/a.Document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 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 there is no evidence to suggest that the customer did not follow the instructions for use.However it should be noted that stent migration is listed as a known potential adverse event within the ifu.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 location of the stent.From the information provided directly by the customer it is known that the stent was implanted just above the knee.From the information provided, it is known that the stents were implanted to treat peripheral arterial disease (pad).It is possible that knee flexion along with the patient¿s pre-existing condition of pad caused and/or contributed to excessive force/pressure on the stent resulting in movement of the stent.As further information and imaging of this event were not available, a definitive root cause could not be determined.Summary the complaint is confirmed based on customer testimony.From the information provided it is unknown if there were any adverse effects to the patient as a result of this event.It is also unknown if any interventions were performed as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 8762095
• MDR Text Key: 150151971
• Report Number: 3001845648-2019-00306
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1