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

Catalog Number ZIV6-35-125-7-60-PTX

Device Problem No Flow (2991)

Patient Problem Thrombosis (2100)

Event Date 04/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, two ziv6-35-125-6-100-ptx and a ziv6-35-125-7-60-ptx were implanted on to a patient.The physician noticed that there was no blood outflow and angioplastied the distal segment again.The physician thought that there may be more disease distally in the fsa and decided to deploy another ziv6-35-125-6-60-ptx.The physician angioplastied the distal segment again and there was still very poor outflow.On inquiring, the physician confirmed that he had not given plavix to the patient.Additional information received stated that the physician administered tpa (trans-plasminogen activating factor) to the patient to see if outflow improved.As per the above complaint description events received, four zilver ptx devices are involved in this incident.Additional separate reports will be submitted in relation to the other three devices.Report reference numbers: 3001845648-2014-00080, 3001845648-2014-00081 and 3001845648-2014-00083.

Manufacturer Narrative

This complaint report meets the reporting criteria of an fda mdr report based on the intervention performed (tpa-trans-plasminogen activating factor) to improve outflow while a zilver ptx stent was implanted.The device involved in this complaint is: 1 x ziv6-35-125-7-60-ptx device of lot number c976466.Details regarding the other three other zilver ptx stents involved in this incident will be submitted under separate reports.Reference numbers 3001845648-2014-00080, 3001845648-2014-00081 and 3001845648-2014-00083.There were no zilver ptx devices of lot number c975466 in stock at the time of the complaint investigation.The stent remains implanted in the patient and therefore is not available for evaluation.A document based investigation was carried out as the device was not available for evaluation.Four undated photographs that were taken of a display monitor during the procedure.The images provided were reviewed.Two photographs show a completely occluded rt sfa.One photograph shows three zilver ptx stents in the rt sfa with slight flow seen proximal which then diminishes.The fourth image is of four zilver ptx stents in the rt sfa with limited blood flow seen throughout the stents.Per the complaint report, the physician implanted three zilver ptx stents from distal to proximal.The physician then performed angioplasty from distal to proximal and proceeded to hand inject afterwards with no blood outflow being seen.Angioplasty was again performed at the distal segment.Another zilver ptx stent was deployed distally as the physician thought there may be more disease distally.Another injection was done with very poor outflow being seen.After the patient was given tpa blood flow was restored according to the report.A total of four zilver ptx stents were placed during the procedure.There was limited blood outflow seen at the end of the procedure despite multiple angioplasty attempts.According to the report the patient was given tpa and blood flow was restored.Unfortunately without any pre-procedure imaging to determine the vessels appearance prior to intervention, it is difficult to determine a cause for this event.Based on the images provided, the customer complaint can be confirmed as limited blood outflow was seen at the end of the procedure despite multiple angioplasty attempts.It may be noted that zilver ptx device involved in this complaint was flushed through both flushing ports, the stent was deployed without issues and patient anatomy was not tortuous and with minimal calcium.The complaint information suggests that the patient experienced limited blood flow due to an acute thrombosis/occlusion key factors that might determine acute thrombosis are usually related to the following: pre and in-procedure anti-coagulation: patient must be appropriately anti-coagulated before and during the procedure.Long procedure times: in some instances many products are used - they all interfere with blood flow and again appropriate in-procedure anti-coagulation medication is needed.Long balloon angioplasty protocols: essentially stops flow for a period of time and appropriate in-procedure anti-coagulation medication is needed.Outflow: if there is any stenosis that is not fully addressed distal to invention area, this can restrict flow and increase the risk of thrombosis.Vessel run-off: if below the knee the flow in the three main tibials is compromised in any way, flow will be slower and the risk of thrombosis increases.Vessel dissection: during a procedure the inner lumen of the vessel can dissect typically during balloon angioplasty.The inner layer tears and flaps down into the vessel - this can restrict flow, so it is essential to address this usually by stenting the tear back up against the inner vessel wall.The following clinical input in relation this incident was provided."the complaint doesn't specifically mention acute thrombosis, but that would be the only reason they were using tpa, so yes, i agree the complaint relates to acute thrombosis.Tpa is not a standard practice in a stenting procedure; it would only be used in a case of acute thrombosis.The chest ((b)(6)) anticoagulation guidelines recommend aspirin or clopidogrel (our product ifu recommends both).We don't know if the patient was on aspirin.For all we know the patient may have had some other contributing factors - perhaps they were hypercoagulable; perhaps there was an underlying dissection resulting in a thrombus that propagated, etc.More metal, more time, more manipulation of devices, etc.Could all be contributing factors.As pointed out above, we don't know if patient had some underlying hypercoagulability disorder or perhaps during the procedure there was intimal damage that served as a nidus for thrombosis." to address the above comments additional information was requested from the sales representative.Additional information received revealed that the patient received clopidogrel (plavix) after the procedure instead of before or during the procedure (as recommended by the zilver ptx instruction for use).Aspirin was also not administered and the patient only received heparin during the procedure.Additional information also confirmed that there were no signs of dissection or intimal damage during the case that could contribute to thrombosis.The patient also did not have any history of clotting disorder.Based on the above it can be stated that medication factor (insufficient antiplatelet therapy) contributed to this acute stent thrombosis and it's very unlikely that poor outflow was caused by the zilver ptx stent.However, as the conditions of use cannot be replicated in the laboratory settings, a definitive root cause of this event cannot be conclusively determined.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan, unknown ; 6134440
• MDR Report Key: 3850484
• MDR Text Key: 4615448
• Report Number: 3001845648-2014-00082
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2015
• Device Catalogue Number: ZIV6-35-125-7-60-PTX
• Device Lot Number: C976466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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: 58 YR