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 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.¿the ptx thumbwheel broke as 1 cm of the sheath came out.The wheel would just free spin without deploying the device.They removed everything from the patient and went back in with a new ptx and sheath and finished procedure as normal.¿ the zisv6-35-125-6-120-ptx device involved in this complaint is not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that the complaint device was advanced over a 0.014¿ diameter, roadrunner extra support wire guide.The device was flushed prior to use.Roughly 1 cm of the stent began deployment, before the thumbwheel malfunctioned, and the physician removed the device as a whole.No portion of the stent or device remained in the patient.The patient had tortuous iliac arteries.Pre-dilation was conducted prior to the attempted stent deployment.The customer has confirmed that the complaint device is unavailable to return for evaluation.The customer services representative was contact to clarify in what type of procedure the complaint device was used.Here is no evidence to suggest that this incident did not occur.Complaint is confirmed based on the customer¿s testimony.Possible cause for this occurrence could be the tortuous patient anatomy, or the use of a non-recommended wire guide.From customer testimony, it is known that the patient had tortuous iliac arteries, and the complaint device was advanced over a 0.014¿ diameter wire guide.A difficult anatomy could have created resistance during deployment, and the non-recommended wire guide could have provided insufficient support during deployment.These factors could have caused or contributed to malfunction of the thumbwheel during deployment.However, as the complaint device has not been returned, and the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.From the product instructions for use : precautions: ¿a 0.035 inch (0.89 mm) 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 the entire lot.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 once product development has reviewed the details of this complaint.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

Initial mdr is being submitted based on the device malfunction precedence: 'thumbwheel malfunctions during deployment'.The ptx thumbwheel broke as 1 cm of the sheath came out.The wheel would just free spin without deploying the device.They removed everything from the patient and went back in with a new ptx and sheath and finished procedure as normal.

• 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 ; EI
• MDR Report Key: 7037345
• MDR Text Key: 93341071
• Report Number: 3001845648-2017-00552
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)190721(10)C1394786
• 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
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/20/2017
• Date Device Manufactured: 08/30/2017
• 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
• Patient Age: 70 YR
• Patient Weight: 66