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

Catalog Number ZIV6-35-125-7.0-40-PTX

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Treatment with medication(s) (2571)

Event Date 12/31/2014

Event Type  Injury  

Event Description

On (b)(6) 2012, 1 (b)(4) ptx was implanted.On (b)(6) 2014 the patient developed cerebral infarction.The medication being administered to the patient was changed and transfusion was performed.By (b)(6) 2015 the condition of th patient had not changed.The physician confirmed that the reported incident was associated with antiplatelet medication as a result of stent placement.

Manufacturer Narrative

(b)(4).The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.Pma/510(k)#: p100022 and s001.

Event Description

This follow up report is being submitted to include the investigation conclusions.On (b)(6) 2012, 1 x (b)(4) was implanted.On (b)(6) 2014 the patient developed a cerebral infarction.The medication being administered to the patient was changed and transfusion was performed.By (b)(6) 2015 the condition of the patient had not changed.The physician confirmed that the reported incident was associated with antiplatelet medication administered as a result of stent placement.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-7.0-40-ptx of lot number c772909 was implanted in the patient and therefore is not available for evaluation.With the information provided, a document based investigation was carried out.Available information has been forwarded to medical science officer and clinical feedback has been requested.The following comments were received in regards to this event: ¿¿a known (but rare) complication of antiplatelet medication is intracerebral bleed, so it¿s possible that if this patient was on antiplatelet drugs solely because he had received a zilver ptx, and the antiplatelet drugs contributed to an intracerebral bleed, then it could be concluded that zilver ptx indirectly contributed to this patient having a stroke.Of course, it¿s impossible to make a definitive link between the zilver ptx and the stroke, just as it¿s impossible to rule out a definitive link between the two¿¿ ¿¿if it turns out the stroke was ischemic and not hemorrhagic, then it would be hard to attribute the stroke to the antiplatelet therapy.If they confirm it was hemorrhagic then you still can¿t definitively blame the stroke on the antiplatelets, but it certainly could contribute¿ in regards to the above comments, additional information has been requested in order to determine type of stroke that occurred in this case.It has been confirmed that this event was associated with the hemorrhage stroke.There is no evidence to suggest that the reported event did not occur, therefore the complaint can be confirmed based on customer testimony.It can be noted that the physician determined that complaint was associated with medication of antiplatelets, which is recommended with zilver ptx stents.According to feedback provided by medical science officer, antiplatelet therapy could have contributed to this event; however at the same time, it¿s impossible to make a definitive link between the zilver ptx and the stroke.Therefore, a definitive cause of the reported event cannot be determined.It can be noted that the following information is included in the package insert supplied with zilver ptx stents: ¿using of this product includes a recommendation for at least 60 days administration of antiplatelet agent after implantation.Therefore, always refer to the instruction of combined antiplatelet agent, and carefully consider the possibility of increasing in risk of bleeding, ttp, agranulocytosis and serious hepatopathy.Also, patient should be advised and understand the characteristics of this device (the risks and benefit) as well as the risks accompanied by the antiplatelet therapy after stent implantation.¿ contraindication section includes the following information: ¿use of this device is contraindicated in below patients.Patients who cannot receive appropriate anti-platelet and/or anti-coagulant therapy.¿ hematoma/hemorrhage is listed as potential adverse event associated with placement of zilver ptx device.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, change of medication and transfusion was performed.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(4).On (b)(6) 2012, 1 x ziv6-35-125-7.0-40-ptx was implanted.On (b)(6) 2014 the patient developed a cerebral infarction.The medication being administered to the patient was changed and transfusion was performed.By (b)(6) 2015 the condition of the patient had not changed.The physician confirmed that the reported incident was associated with antiplatelet medication administered as a result of stent placement.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 4941936
• MDR Text Key: 15589033
• Report Number: 3001845648-2015-00144
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2015,09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2013
• Device Catalogue Number: ZIV6-35-125-7.0-40-PTX
• Device Lot Number: C772909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/31/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR