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

Catalog Number ZISV6-35-80-6.0-80-PTX

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

Patient Problems Tingling (2171); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.The zisv6-35-80-6.0-80-ptx device of lot c1237312 was implanted in the patient, and is not available for evaluation.With the information provided, a document based investigation was conducted.Images of the procedure or the implanted device are not available.From customer information, the physician suggested that the patient had an allergy to the nickel in the nitinol stent.The complaint device was implanted in the superficial femoral artery (sfa).There is no evidence to suggest this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Clinical input was requested and provided.The following statements were made."this patient¿s pre and current medical condition were not clear.The location of numbness and tingling in this patient was not specified (both feet or one arm and one foot?).In zilver ptx, paclitaxel is used as an anti-proliferation agent (stop cell growing).Common side effects of paclitaxel include numbness and tingling in the hands and/or feet (peripheral neuropathy) which has been stated in the ifu.According to the latest information provided: ¿the physician thinks that the patient has a nickel allergy in patient after nitinol stent implant.The patient thinks it also.The patient did not require any additional treatments.¿ ¿allergic reaction to nitinol¿ has been documented in the ifu.The potential symptoms such as persistent pruritus, pruritic rashes, eczema or dermatitis and treatment/management are at the discretion of his/her physician." possible causes for this occurrence could be a patient allergy either to the material of the stent or the paclitaxel drug coating.The following is noted in the product ifu: ¿persons with allergic reactions to nitinol may suffer an allergic reaction to this implant¿ ¿persons allergic to paclitaxel may suffer an allergic reaction to this implant¿ in addition, potential adverse events associated with the placement of this device include the following: - allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium, - allergic reaction to nitinol, - hypersensitivity reactions, - peripheral neuropathy, also, allergic/immunologic reaction to the drug coating is listed in the potential adverse events that may be unique to the paclitaxel drug coating.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this 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 c1237312.From customer testimony, no further treatments were required as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Patient complained about being uncomfortable after procedure with numbness and tingling in half of his body.The treatment was performed in a different hospital.

Manufacturer Narrative

This follow up report is being submitted to cancel the initial report sent in relation to this event.Initial assessment was a conservative assessment pending completion of a risk assessment of this event.Risk analysis has now been completed and the overall risk is low.No medical/surgical intervention has been reported.The symptoms of numbness and tingling does not meet the definition of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No device malfunction has been reported and no malfunction reporting precedence's exist for this type of event for this device.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Pma/510(k) # p100022/s014.The zisv6-35-80-6.0-80-ptx device of lot c1237312 was implanted in the patient, and is not available for evaluation.With the information provided, a document based investigation was conducted.Images of the procedure or the implanted device are not available.From customer information, the physician suggested that the patient had an allergy to the nickel in the nitinol stent.The complaint device was implanted in the superficial femoral artery (sfa).There is no evidence to suggest this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Clinical input was requested and provided.The following statements were made."this patient¿s pre and current medical condition were not clear.The location of numbness and tingling in this patient was not specified (both feet or one arm and one foot?).In zilver ptx, paclitaxel is used as an anti-proliferation agent (stop cell growing).Common side effects of paclitaxel include numbness and tingling in the hands and/or feet (peripheral neuropathy) which has been stated in the ifu.According to the latest information provided: ¿the physician thinks that the patient has a nickel allergy in patient after nitinol stent implant.The patient thinks it also.The patient did not require any additional treatments.¿ ¿allergic reaction to nitinol¿ has been documented in the ifu.The potential symptoms such as persistent pruritus, pruritic rashes, eczema or dermatitis and treatment/management are at the discretion of his/her physician." possible causes for this occurrence could be a patient allergy either to the material of the stent or the paclitaxel drug coating.The following is noted in the product ifu: ¿persons with allergic reactions to nitinol may suffer an allergic reaction to this implant¿ ¿persons allergic to paclitaxel may suffer an allergic reaction to this implant¿ in addition, potential adverse events associated with the placement of this device include the following: - allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium - allergic reaction to nitinol - hypersensitivity reactions - peripheral neuropathy also, allergic/immunologic reaction to the drug coating is listed in the potential adverse events that may be unique to the paclitaxel drug coating.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this 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 c1237312.From customer testimony, no further treatments were required as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.H3 other text : this follow up report is being submitted to cancel the initial report sent in relation to this event.Initial assessment was a conservative assessment pending completion of a risk assessment of this event.Risk analysis has now been completed and the overall risk is low.No medical/surgical intervention has been reported.The symptoms of numbness and tingling does not meet the definition of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No device malfunction has been reported and no malfunction reporting precedence's exist for this type of event for this device.

Event Description

This follow up report is being submitted to cancel the initial report sent in relation to this event.Initial assessment was a conservative assessment pending completion of a risk assessment of this event.Risk analysis has now been completed and the overall risk is low.No medical/surgical intervention has been reported.The symptoms of numbness and tingling does not meet the definition of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No device malfunction has been reported and no malfunction reporting precedence's exist for this type of event for this device.Initial report details: patient complained about being uncomfortable after procedure with numbness and tingling in half of his body.The treatment was performed in a different hospital.

• 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 Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6460649
• MDR Text Key: 71733685
• Report Number: 3001845648-2017-00118
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353098
• UDI-Public: (01)10827002353098(17)180414(10)C1237312
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-80-6.0-80-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2017
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2017
• Date Device Manufactured: 05/30/2016
• 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