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

Model Number G38482

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information pertaining to contact officeas follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s014.¿the stent went in okay and when deploying the stent on the thumbwheel, the mechanism in the device broke.The thumbwheel would spin without any action on the stent.The physician treated it as a pin and pull and was able to deploy the device successfully.¿ the device was returned and received 20-oct-17.With the information currently available, a document based investigation was conducted.The investigation will be updated once the device has been evaluated.From customer testimony, it is known that the complaint device was advanced over a roadrunner wire guide, of 0.014¿ diameter which was switched for a quartus emerald wire.The complaint device was flushed prior to use.The stent was eventually deployed.The target lesion was severely calcified.Pre-dilation was conducted prior to stent deployment.There is no evidence to suggest that this incident did not occur.Complaint is confirmed based on the customer¿s testimony.Possible causes for this occurrence include the severely calcified lesion, or the use of an incorrect wire guide.The difficult anatomy could have created resistance during deployment, and the incorrect wire guide could have provided insufficient support during deployment, which could have caused or contributed to the failure to deploy the stent.However, as the complaint device has not yet been returned, and the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.It can be noted that as per the product instructions for use: ¿a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system¿ 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.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.It may be noted that the failure mode of "deployment difficult" has been provisionally assigned.The final failure mode will be confirmed following device return and evaluation.There is no evidence to suggest that this incident did not occur.Complaint is confirmed based on the customer¿s testimony.According to information provided, the patient did not experience any adverse effects due to this occurrence.The risk will be assessed for this complaint once the device has been evaluated by research and development.When completed the investigation will be updated with the risk details.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Reporting based on the device malfunction reporting precedence for this device family for the issue of 'thumbwheel malfunctions during deployment'' and 'stent fracture'.The stent went in okay and when deploying the stent on the thumbwheel, the mechanism in the device broke.The thumbwheel would spin without any action on the stent.The physician treated it as a pin and pull and was able to deploy the device successfully.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) #p100022/s014.A follow-up mdr is being submitted to include the device evaluation details.The zisv6-35-125-6-120-ptx device of lot number c1390840 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the complaint device was used with a roadrunner wire guide, of 0.014¿ diameter which was switched for a quartus emerald wire.The complaint device was flushed prior to use.The stent was eventually deployed.The target lesion was severely calcified.Pre-dilation was conducted prior to stent deployment.Further information was received from the customer.The complaint device was advanced from a contralateral, femoral access approach, through a six french 45cm access sheath.The target location was the distal superficial femoral artery (sfa).Details of the patients weight or height are unknown.The district manager cannot confirm the details of the quartus emerald wire guide, which was either 0.018¿ or 0.035¿ diameter.It is unknown which wire guide was used with the complaint device during deployment.On evaluation of the returned device, it was observed that the device was returned with the safety trigger depressed, and without the stent.The distal end of the stent retraction sheath (srs) was significantly shape set in a coil, with crinkles on the sheath at a 5mm pitch.A kink was observed in the stability sheath, 23.5cm from the strain relief.The engineers used the thumbwheel mechanism, which spun freely.The handle was opened, and the stent retraction wire was observed separated from the stent retraction sheath.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was observed separated from the stent retraction sheath.Possible causes for this occurrence include the severely calcified lesion, or the use of an incorrect wire guide.The difficult anatomy could have created resistance during deployment, which could have led to the shape set coiling and the crinkles in the stent retraction sheath.The incorrect wire guide could have provided insufficient support during deployment.These factors could have caused or contributed to the retraction wire separating from the stent retraction sheath during deployment.However, as the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.It can be noted that as per the product instructions for use: ¿a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system.¿ 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.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 lot number c1390840.According to information provided, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

A follow-up mdr is being submitted to include the device evaluation details.Initial report details: the stent was advanced successfully and when deploying the stent on the thumbwheel, the mechanism in the device broke.The thumbwheel would spin without any action on the stent.The physician treated it as a pin and pull and was able to deploy the device successfully.Reporting based on the device malfunction reporting precedence for this device family for the issue of 'thumbwheel malfunctions during deployment'' and 'stent fracture'.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6976185
• MDR Text Key: 90993635
• Report Number: 3001845648-2017-00484
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)180620(10)C1390840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

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 Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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