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

Catalog Number UNKNOWN

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations over the phone "the thumbwheel broke during deployement." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment'.No adverse effects to the patient have been reported as occurring.This complaint report does not meet the requirements of an adverse reaction/device defect report as per 21 cfr part 814.82 (a)(9).

Manufacturer Narrative

Device evaluation: the zilver ptx device of unknown lot number involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated once the device has been returned and evaluated.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0118-5) states the following: ¿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.If hydrophilic wire guides are used, they must be kept fully activated.¿ ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.It is possible that difficult patient anatomy resulted in resistance during advancement and attempted deployment which may have caused a build-up of tension along the retraction wire.It is possible that as the user attempted to rotate the thumbwheel, the tension along the retraction wire resulted in the wire separating from the stent retraction sheath resulting in inability for the user to begin/complete deployment of the stent.Summary: the complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations over the phone "the thumbwheel broke during deployement." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment' and 'retraction wire seperates from stent retraction sheath'.No adverse effects to the patient have been reported as occurring.

• 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; national technology park; limerick
• MDR Report Key: 9217247
• MDR Text Key: 220536061
• Report Number: 3001845648-2019-00559
• 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
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1