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

Catalog Number ZIV6-35-80-7-100-PTX

Device Problems Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017)

Patient Problems Occlusion (1984); Therapy/non-surgical treatment, additional (2519); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

Four zilver ptx stents were placed in the pts left leg (b)(6) 2014.The patient was administered plavix at the time of the procedure.In (b)(6) 2014, the patient experienced difficulty with walking long distances and was scheduled for an abi/us where blockage of the stents was confirmed.During an angio procedure (b)(6) 2014 the physician could not get inside stents and open them up.The physician said he would send the patient for a bypass procedure or prescribe pletal.The patient declined the bypass surgery.Physician administered pletal and a full strength asa.The patient refused to take the pletal.The patient also stated that she had some bleeding in her nose and stopped taking her plavix because she read some data that showed that plavix causes bleeding.The patient self stopped this medication.The stents remain in the patient.The patient does not want to return to the user facility and is seeking a referral for a new vascular interventionist.As 4 zilver ptx devices are suspected to be involved in this event reference also related reports, 3001845648-2014-00215, 3001845648-2014-00216 and 3001845648-2014-00217.

Manufacturer Narrative

Pma/510 (k)#: p100022 and s001.Udi #: unknown.Complaint details were received as follows: procedure 4 zptx stents placed in left leg, it was done on (b)(6) 2014 at (b)(6).The physician prescribed the patient a baby asa and had the patient take plavix at the time of procedure.In (b)(6) 2014, the patient went on a "senior trip" for 3 days and was only able to walk short distances without stopping.When the patient returned she went to see the physician again and was scheduled for abi/us and physician found blockage of the stents.The physician set the patient up for an angio.The physician had the procedure on (b)(6) 2014 - where the physician explained he was not able to get inside the stents and open them up.The physician said he could send patient for a bypass or put her on pletal, patient declined bypass.The physician prescribed pletal and a full strength asa.The patient did not fill pletal and refused to take it.The patient also stated that she had some bleeding in her nose and stopped taking her plavix because she read some data that showed that plavix causes bleeding.The patient self stopped this medication.The device involved in this complaint was identified as the zilver ptx drug eluting stent.The specific rpn and lot number of the device involved has not been provided.The stent was implanted in the patient and therefore is not available for evaluation.With the information provided, a document based investigation was carried out.Although requested images relating to this event were not provided.Information received states that four zilver ptx stents were placed in the patients left leg.As per the instructions for use, ifu0093-4 which accompanies zilver ptx devices, "the effect of implanting more than three zilver ptx drug eluting peripheral stents in a patient has not been clinically evaluated".It may be noted that as per instructions for use ifu0093-4 which accompanies zilver ptx devices, re-stenosis is a common adverse event of endovascular procedures.This can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads (or amplifies) to the restenosis process.A review of the relevant manufacturing records for zilver ptx and zilver ptx drug eluting stents could not be performed as the lot number of the complaint device was not provided.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUDING STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUDING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 4223603
• MDR Text Key: 5002785
• Report Number: 3001845648-2014-00214
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-80-7-100-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 45