MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-6-100-PTX

Device Problem No Apparent Adverse Event (3189)

Patient Problem Rash (2033)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.According to the complaint description, three zilver ptx devices were implanted in the patient.This investigation addresses ziv6-35-125-6-80-ptx stent of lot number c1169941.The device involved in this complaint was not available for evaluation, the device remain implanted in the patient.With the information provided a document based investigation was carried out.According to the complaint information, two days post procedure the patient returned and indicated that she had a raised rash from her knee down to her foot on her left leg.Upon examination by the physician, there were no other noted allergic reactions or complications.The physician performed a blood test on the patient and confirmed there was no infection.At this point, the physician believed the rash was strictly secluded to the left leg due to the implanted stents.The physician prescribed a steroid dose pack for the patient.Upon follow up on (b)(6) 2016, the rash has reduced approximately 25%; however 75% percent of the rash remains.In this case, it is known that the patient has the following pre-existing conditions: allergy to nickel & pvd.The complaint details were forwarded for a clinical opinion.The following feedback was provided by the medical science officer: "is this rash a symptom of an allergic reaction to the stent materials? that¿s what the reporting physician suggested; it seems plausible, though impossible to say with absolute certainty could this reaction be deemed as life threatening? no, i would not consider this reaction life-threatening.I don¿t believe there is any way to refute the physician¿s claim that the rash resulted from the stents, and i doubt there¿s any way to definitively prove it.There are rare reports in the literature of allergic reactions to stents and other nickel-containing devices, though i¿ve not see anything with a localized rash as described here.I think there¿s a very reasonable likelihood that the allergic reaction is to the nickel in the stent.As noted in my earlier email, there¿s no way to be 100% certain of this¿.Additional information has been requested to support the complaint investigation however to date no further information has been provided.Images to support the complaint investigation were requested.If images are available the investigation will be updated with imaging review.Based on the above, it is possible the cause of this event was due to patient allergy to the nickel in the stent.The reaction was not considered life-threatening by the medical science officer.However, as the conditions of use could not be replicated in a laboratory setting, a definitive root cause cannot be determined.There is no evidence to suggest that this event did not occur; therefore the complaint is confirmed based on customer testimony.It may be noted that the following information is provided in the instructions for use: the zilver ptx drug-eluting peripheral stent is a self-expanding stent made of nitinol and coated with the drug paclitaxel.The following information is included in the instruction for use, section ¿warnings¿: persons with allergic reactions to nitinol, or its components, nickel and titanium, may suffer an allergic reaction to this implant.Persons allergic to paclitaxel or structurally-related compounds may suffer an allergic reaction to this implant.In addition, as per instruction for use, 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.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 revealed no discrepancies that could have contributed to this complaint.There is no evidence to suggest that this issue effects the entire lot # c1169941; upon review of complaints this failure mode has not occurred previously with this lot # c1169941.The physician prescribed a steroid dose pack to treat the rash.Upon follow up on (b)(6) 2016, the rash has reduced approximately 25%; however 75% percent of the rash remains.Additional information has been requested regarding the patient outcome.However no further information has been provided to date.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Three zilver grafts were implanted in the patients left leg on (b)(6) 2016.The procedure was completed successfully and the patient had great blood.On (b)(6) 2016 the patient called back into the office and spoke with the physician indicating she had a raised rash from her knee down to her foot.The physician told the patient to come back into the office straight away for examination.Upon examination by the physician, there were no other noted allergic reactions or complications.The physician performed a blood test on the patient and confirmed there was no infection.At this point, the physician believed the rash was strictly secluded to the left leg due to the implanted stents.The physician prescribed a steroid dose pack for the patient.Upon follow up on (b)(6) 2016, the rash has reduced approximately 25%; however 75% percent of the rash remains.The patients family is extremely concerned because the patient was placed on a blood thinner (plavix), which keeps the stents open.The facility believes the reaction is not due to the plavix, however solely related to the implanted stents.As three zilver stents are suspected to be involved in this event, a separate report has been submitted for each suspect device.Reference reports 3001845648-2016-00199 & 3001845648-2016-00200.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5853352
• MDR Text Key: 51370262
• Report Number: 3001845648-2016-00198
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)160818(10)C1169941
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2016
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2016
• Date Device Manufactured: 11/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76