MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number	G43828
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During deployment the user was unsheathing the stent, but the sheath material was elongating without the intended sheath movement.When the handle reached the hub, the stent was not fully deployed.The dm advised to keep a little bit of tension and pull back slowly.The user followed advise and the stent was able to be deployed in the target location.
Event or Problem Description
During deployment the user was unsheathing the stent, but the sheath material was elongating without the intended sheath movement.When the handle reached the hub, the stent was not fully deployed.The dm advised to keep a little bit of tension and pull back slowly.The user followed advise and the stent was able to be deployed in the target location.Did any unintended section of the device remain inside the patient¿s body? no did the patient require any additional procedures due to this occurrence? no did the product cause or contribute to the need for additional procedures? no has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effects?.
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003 device evaluation the ziv6-35-125-7-80 device of lot number c1649230 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 (b)(6) 2020.The tip was missing.A request was sent to the customer to determine the location of the tip.See pr287936_additional information.No response has been received as per dv0001556 no further communication will be sent.If a response is received at a later stage the file will be updated.Document review prior to distribution ziv6-35-125-7-80 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 (b)(4) 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 c1649230.There is evidence to suggest that the customer did not follow the instructions for use (ifu0043-9).¿the zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty(pta) in the treatment of symptomatic disease of the iliac arteries¿ image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression 1.Stretching of the delivery sheath cannot be confirmed as imaging of the event was not provided.The imaging does confirm a stent appearance consistent with successful deployment and expansion for this location.2.The severe tortuosity inherent to this location is uniquely more challenging than other veins.At all other locations, a vein¿s ability to move and straighten under the influence of the guidewires and catheters reduces friction.Because the sinuses are adherent to the bone, they are incapable of straightening.This generates more friction than similar tortuosity would elsewhere.Root cause review a definitive root cause could be determined from the available information.The device was used in the transverse sinus which is off label use.It is unknown how the device would function outside of its intended use.Summary the complaint is confirmed based on customer testimony.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.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9590291
• Report Number: 3001845648-2020-00037
• Device Sequence Number: 16292499
• Product Code: NIO
• UDI-Device Identifier: 10827002438283
• UDI-Public: (01)10827002438283(17)220913(10)C1649230
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2022
• Device Model Number: G43828
• Device Catalogue Number: ZIV6-35-125-7-80
• Device Lot Number: C1649230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR