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
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	08/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k)#: p100022.The ziv6-35-125-7-60-ptx stent of lot number c1164262 was implanted in the patient, and therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation and the following comments were provided by the independent reviewer: findings: a single image is provided demonstrating a distal left sfa stent measuring 64mm long and 5mm in diameter.Because the calibration tape was straight, it was likely on the table and not on the anterior leg.Consequently the stent¿s measured diameter was likely minified 10-20% depending on the legs thickness.The actual diameter was likely 5.5-6mm and the length 70-77mm.No external compression was present.No stent fracture was present however the resolution was such that only type 3 or greater fractures could be resolved.The sfa was severely calcified.Impression: other than likely being stretched, the stent appeared normal on this single image of the stent.Because the image was a fluoroscopic image without intravascular contrast, the occlusion cannot be confirmed.Significant findings relative to the patient¿s anatomy were not observed.Significant findings relative to the disease state were observed.The artery was severely calcified.Significant findings relative to the use of the device were not observed.Significant findings relative to the design or the performance of the device were not observed.Cause of adverse events was not observed.The image provided was a still fluoroscopic image with no intravascular contrast.As such, the occlusion cannot be confirmed from the image.However, there is no evidence to suggest this event did not occur, therefore the customer complaint is confirmed based on customer testimony.It was not reported if the patient had any potential risk factors for thrombosis.However, from the image review, it was noted that the patient had a severely calcified anatomy, which is a known potential risk factor for thrombosis.It is unlikely that the reported thrombosis occurred due to device malfunction, however as the conditions of use cannot be replicated and due to the limited information available, a definitive root cause cannot be determined and no other comments can be made.It may be noted that as per the instructions for use arterial thrombosis is a known potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Instruction.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.According to information provided, treatment included thrombolysis and stent placement.No adverse effects were reported for the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
Following zilver ptx stent implantation the patient returned with a pain in their foot.Physician took angio and the stent was confirmed to be thrombosed.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6036410
• Report Number: 3001845648-2016-00295
• Device Sequence Number: 10952138
• Product Code: NIU
• UDI-Device Identifier: 10827002248943
• UDI-Public: (01)10827002248943(17)160923(10)C1164262
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZIV6-35-125-7-60-PTX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 10/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR