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

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Human-Device Interface Problem (2949)

Patient Problems High Blood Pressure/ Hypertension (1908); Reaction (2414)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-6-80-ptx stent of lot number c1107343 was implanted in the patient and is unavailable for evaluation.Based on the information provided a document based investigation will be carried out.No images were available at the time of complaint investigation.Available information was forwarded for clinical input.The following comments were received: "we have not had similar reports from any of the clinical studies that i am aware of.Most hypersensitivity-type reactions reported in those studies were due to medications (antiplatelet or others) or contrast.¿ it may be noted that the following information is provided in the instructions for use provided with the device: "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.Hypersensitivity reactions.¿¿.Potential adverse events, not described in the above source, may be unique to the paclitaxel drug coating: allergic/immunologic reaction to the drug coating".There is no evidence to suggest that a reaction did not occur, therefore, the complaint is confirmed based on customer testimony.According to clinical input provided most hypersensitivity reactions reported in such studies are due to medications or contrast.However, as no imaging was provided and the conditions of use could not be replicated, no definite root cause can be determined for the adverse effects observed.Due to limited information no other comments can be made.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.According to information provided patient's condition improved with medical treatment and no other devices were used.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2015 a male patient in their early 70's underwent a leg angiogram procedure.When the zilver ptx stent was deployed, the patient had a reaction.Blood pressure dropped out, tingling in the face, hot forehead, minor chest pains, burning in the thigh.Hr was okay.Iv fluids were given to counteract the hypertension.Symptoms resolved within a couple of minutes of fluid administration.No other medications were given.Last sedation was given 10 minutes prior to this event.

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-6-80-ptx stent of lot number c1107343 was implanted in the patient and is unavailable for evaluation.With the information provided a document based investigation will be carried out.Available information was forwarded for clinical input.The following comments were received: "we have not had similar reports from any of the clinical studies that i am aware of.Most hypersensitivity-type reactions reported in those studies were due to medications (antiplatelet or others) or contrast.Also, i noticed that the medtronic dcb has a potential ae of hypotension/hypertension.¿ according to clinical input provided most hypersensitivity reactions reported in such studies are due to medications or contrast images were provided to support the complaint investigation.These were reviewed and the following comments were provided by the independent reviewer: ¿findings: ¿.5.The lesion was likely first treated with angioplasty as an un-inflated angioplasty balloon was demonstrated across the lesion.The lesion was then treated with silver hawk orbital atherectomy.Greater than 50% stenosis was present in the distal sfa and proximal popliteal artery post angioplasty and atherectomy.6.30-50% residual stenosis was also present in the popliteal artery at and just superior the patella.7.The most severe residual stenosis in the distal sfa and proximal popliteal artery was eliminated with the zilver ptx stent with the exception of mild residual stenosis in the proximal stent from residual heavily calcified plaque.Impression: 1.Angiography demonstrates successful resolution of residual stenosis with a zilver ptx stent after initial angioplasty and orbital atherectomy.The lesion was a heavily calcified moderate to severe distal right sfa into popliteal artery stenosis.2.Untreated 50% right common iliac artery origin and residual popliteal 30-50% stenoses represent a challenge to future patency.3.The clinical complaint most likely represented a type i hypersensitivity reaction.The most likely antigen was paclitaxel.A case report of presumed hypersensitivity to paclitaxel has been reported after taxus stent implantation (dermatology.2009;218(1):52-5).4.Significant findings regarding the patient¿s anatomy, disease state, and use of the device relating to the complaint of hypersensitivity reaction were not observed.Nothing was observed that suggested increased risk for hypersensitivity reaction.5.Significant findings relative to the patient¿s disease state, and use of the device were observed.Specifically the unresolved inflow and outflow stenoses increase the risk of future significant in-stent stenosis.6.Significant findings relative to the design or performance of the device were not observed.The mild residual in-stenosis was insignificant.¿ there is no evidence to suggest that this event did not occur; therefore the complaint is confirmed based on customer testimony.Based on the imaging review, significant findings relating to the complaint of hypersensitivity reaction were not observed.Nothing was observed that suggested an increased risk of a hypersensitivity reaction.According to the independent reviewer, the most likely cause of the type i hypersensitivity reaction was paclitaxel.However, as the conditions of use could not be replicated, no definitive root cause can be determined.It may be noted that the following information is provided in the instructions for use provided with the device: "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 - hypersensitivity reactions ¿¿.Potential adverse events, not described in the above source, may be unique to the paclitaxel drug coating: - allergic/immunologic reaction to the 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.According to information provided patient's condition improved with medical treatment and no other devices were used.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the receipt and review of images relating to this event.Initial description submitted as follows: on (b)(6) 2015 a male patient in their early 70's underwent a leg angiogram procedure.When the zilver ptx stent was deployed, the patient had a reaction.Blood pressure dropped out, tingling in the face, hot forehead, minor chest pains, burning in the thigh.Hr was okay.Iv fluids were given to counteract the hypertension.Symptoms resolved within a couple of minutes of fluid administration.No other medications were given.Last sedation was given 10 minutes prior to this event.

• 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: 5181920
• MDR Text Key: 29404492
• Report Number: 3001845648-2015-00211
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6-80-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: 09/29/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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