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COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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| Catalog Number UNKNOWN |
| Device Problems
Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Pain (1994); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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Report is being submitted based on prolonged hospitalization (3 days in hospital following the index procedure).As reported to customer relations - per patient "my name is (b)(6).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 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).After a couple of months i decided to go see a vascular specialist in (b)(6) 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 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 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.
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Manufacturer Narrative
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Pma/510(k) # : p100022.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Report is being submitted based on prolonged hospitalization (3 days in hospital following the index procedure).As reported to customer relations - 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 (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 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.
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Manufacturer Narrative
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Pma/510(k) # : p100022.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Additional information has been received and the investigation has been re-opened.Initial description: report is being submitted based on prolonged hospitalization (3 days in hospital following the index procedure).As reported to customer relations - per patient "my name is (b)(6).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 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 (b)(6) 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 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 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.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 described an adverse reaction following the index procedure and required prolonged hospitalization.
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Event Description
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Report is being submitted based on prolonged hospitalization (3 days in hospital following the index procedure) as reported to customer relations - per patient "my name is alena heczkova.On december 26, 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 december 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 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.
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Manufacturer Narrative
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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)(6).Importer site establishment registration number: (b)(4).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 pr 239451, pr 267674, pr 238456 and pr 268014.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 the ifu states the following; ¿potential adverse events potential adverse events that may occur include, but are not limited to, the following: ¿ allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium.¿ allergic reaction to nitinol¿.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 sensitivity to the stent material, anaesthetic used during the procedure and/or other medications that the patient may have been given prior to or during the procedure (e.G.Anticoagulant or antithrombotic therapy or contrast medium).As further information was 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 known that the patient experienced high pain levels, swelling in both legs and hands and the patient also presented with a rash (exact location of the rash is unknown).The patient remained in hospital for 3 days after the index procedure as a result of the aforementioned complications.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Report is being submitted based on prolonged hospitalization (3 days in hospital following the index procedure).As reported to customer relations - per patient "my name is (b)(6).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 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 (b)(6) 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 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 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.
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Manufacturer Narrative
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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.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 (ifu0118-5).However, it should be noted that the ifu states the following; ¿potential adverse events potential adverse events that may occur include, but are not limited to, the following: allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium.Allergic reaction to nitinol¿.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to sensitivity to the stent material, anaesthetic used during the procedure and/or other medications that the patient may have been given prior to or during the procedure (e.G.Anticoagulant or antithrombotic therapy or contrast medium).As further information was 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 known that the patient experienced high pain levels, swelling in both legs and hands and presented with a rash (exact location is unknown).The patient remained in hospital for 3 days after the index procedure as a result of the aforementioned events.Complaints of this nature will continue to be monitored for potential emerging trends.
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Report is being submitted based on prolonged hospitalization (3 days in hospital following the index procedure).As reported to customer relations: per patient "my name is (b)(6).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 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.On (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 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 on (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 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.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 described an adverse reaction following the index procedure and required prolonged hospitalization.
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