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

Catalog Number ZIV6-35-125-7.0-60-PTX

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for stent fracture, regardless of the patient outcome.This complaint is related to 1 x ziv6-35-125-7.0-60-ptx device of lot number c774345.The ziv6-35-125-7.0-60-ptx of lot number c774345 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were requested to support the complaint investigation, however it has been confirmed that no images will be provided.As no imaging was available, there is no evidence to suggest that stent fracture did not occur therefore this complaint is confirmed based on customer testimony.It can be noted that stent fracture type 1 (single strut fracture) was observed 3 years after stent implantation.It is possible that the stent fracture could have occurred due to patient¿s lifestyle; however this cannot be confirmed.Due to limited information and lack of imaging, the root cause of this complaint cannot be determined and no other comments can be made.According to package insert supplied with each zilver ptx device, stent strut fracture is noted as potential adverse event associated with the placement of this device.In addition, the following information is provided: ¿through clinical trial, it has been shown that stent fracture rates in (b)(6) patients may be higher than the rest of the world.The clinical significance is unknown since these fractured cases have not been associated with any clinical sequelae, however, take enough consideration into the lifestyle of the patient in (b)(6).¿ 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 no medical or surgical intervention was performed and no adverse effects to the patient have been reported.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012: ziv6-35-125-7.0-60-ptx was placed in the left sfa of a (b)(6) male patient.On (b)(6) 2015:type i stent fracture was observed on middle part of the stent.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.This follow up report is being submitted to cancel the initial report submitted.Images relating to this event were reviewed which confirmed this event did not relate to a cook manufactured device.Image review details as follows: ¿findings: implantation angiography and 3 year post implantation x-rays are provided along with the complaint report.A mid-left stent with 6 markers on each end was fractured in the middle in a type 1 fashion.A more distal sfa stent with 6 markers on each end was intact.A proximal 60mm long stent with 4 markers on each end representing a zilver ptx stent was intact.Impression: the type i stent fracture involved a non-cook stent, likely a smart stent.The zilver ptx stent was normal.

Event Description

This follow up report is being submitted to cancel the initial report submitted.Images relating to this event were reviewed which confirmed this event did not relate to a cook manufactured device.Image review details as follows: findings: implantation angiography and 3 year post implantation x-rays are provided along with the complaint report.A mid-left stent with 6 markers on each end was fractured in the middle in a type 1 fashion.A more distal sfa stent with 6 markers on each end was intact.A proximal 60mm long stent with 4 markers on each end representing a zilver ptx stent was intact.Impression: the type i stent fracture involved a non-cook stent, likely a smart stent.The zilver ptx stent was normal.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5073623
• MDR Text Key: 25615762
• Report Number: 3001845648-2015-00173
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• 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: Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7.0-60-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: 07/23/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2012
• 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 Age: 69 YR