MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZFV6-125-8-6.0

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Device evaluation: the zfv6-125-8-6.0 device of lot number c1604936 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 05dec2019.The stent was partially deployed at the tip.The outer sheath was damaged at the approximately 18.5cm from the tip.The stent appeared distorted upon return.However once the stent was deployed and expanded no damage was observed.Document review: prior to distribution zfv6-125-8-6.0 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 a review of the relevant manufacturing records (c1604936) 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 c1604936.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0058-4).Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the outer sheath becoming compressed as the device was advanced in an area that was tortuous and/or calcified.This compression could cause or contribute to the premature stent deployment as the device was being advanced.The difficult patient anatomy may have also contributed to the resistance felt by the user during advancement and the damage on the outer sheath.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, 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

After the user advanced the delivery system alone the sheath into the target location, the user observed the stent was partly deployed , but the red safety valve has not pulled out.So the user removed the whole delivery system from the patient and change another new device with same type to finished the procedure successfully.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿premature stent deployment with safety lock in place'.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).

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick
• MDR Report Key: 9494551
• MDR Text Key: 220754163
• Report Number: 3001845648-2019-00761
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002518909
• UDI-Public: (01)10827002518909(17)220417(10)C1604936
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2022
• Device Catalogue Number: ZFV6-125-8-6.0
• Device Lot Number: C1604936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2019
• 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: 71 YR
• Patient Weight: 70