MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number G57448

Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Common name: qan.Pma # (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As initially reported to customer relations via email: a (b)(6) year old male patient underwent a filter placement procedure in which a vena cava 16x100 filter was used.Access was via right common femoral vein antegrade with cook medical mpis.Stent placement was right common iliac vein.It was a 16x100, but when deployed looked more like a 16x80.After reviewing the case, it looked like the stent deployment system was possibly pushed forward during deployment causing the stent struts to collapse together.The stent was checked with ivus and the stent did not look fractured and had luminal gain.The stent collapse was noticed immediately post deployment.Angiographic findings: left lower extremity - synechiae and spurs formation left common iliac vein - significant compression, narrowing and stenosis with significant visible reflux left external iliac vein - significant compression, narrowing and reflux left common femoral vein - moderate narrowing right common iliac vein - significant compression, narrowing with reflux right external iliac vein - significant compression, narrowing and reflux right common femoral vein - moderate narrowing.Intravascular ultrasound interpretation: ivc - 206mm2/13x19mm left common iliac vein - reference area 200mm2, compression area/ difference 73mm2/7x15mm.Difference = 51% left external iliac - vein reference area 150mm2, compression area/difference 73mm2/7x15mm.Difference = 51% left common femoral - vein reference area 125mm2, compress area/diameter - 116mm2/11x13mm right common iliac - vein reference area 200mm2, compress area / diameter - 124mm2/11x14mm.Difference 38%.Post stenting area/diameter - 164mm2/12x16mm right external iliac - vein reference area of 150mm2, compress area / diameter - 68mm2/7x13mm.Difference 55%.Post stenting area/diameter - 135mm2/13x14mm right common femoral - vein reference area of 125mm2, compress area / diameter 94mm2/10x12 mm.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? if yes, please describe.The patient will be brought back in 1 month post stent deployment to ivus the placement of the stent and to confirm symptoms have cleared.Did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.The patient will be brought back in 1 month post stent deployment to ivus the placement of the stent and to confirm symptoms have cleared.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? no.Please specify adverse effects and provide details.

Event Description

Supplemental report is being submitted due to the imaging review on 23-feb-2022: impression: 1.Zvt7-35-80-16-100 implantation with crowding and or telescoping of the inferior stent is confirmed.However, this did not restrict the lumen.2.The provided imaging cannot confirm why the stent deployed crowded and or telescoped.Engineering user error confirmed on 08-mar-2022.Imdrf a code updated to capture user error.

Manufacturer Narrative

Common name: qan.Pma # p200023.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Common name: qan.Pma # p200023.Device evaluation: the zvt7-35-80-16-100 device of lot number c1855133 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution zvt7-35-80-16-100 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 manufacturing records for zvt7-35-80-16-100 of lot number c1855133 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1855133.It should be noted that the instructions for use ifu0091-8 states the following: ¿continue deployment of stent by sliding the handle toward the hub in a slow, smooth and consistent fashion¿.There is evidence to suggest the user did not follow the instructions for use.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.Zvt7-35-80-16-100 implantation with crowding and or telescoping of the inferior stent is confirmed.However, this did not restrict the lumen.2.The provided imaging cannot confirm why the stent deployed crowded and or telescoped.Root cause review: a definitive root cause of user error was identified from the available information.The ifu states that : ¿continue deployment of stent by sliding the handle toward the hub in a slow, smooth and consistent fashion¿.According to the complaint, the device was pushed forward during deployment.The user did not use the pin and pull method for deployment.As a result of this incorrect/improper technique, the stent crumpled out as the user deployed the stent.Summary: complaint is confirmed as the failure was verified in the images.Implantation with crowding and or telescoping of the inferior stent was confirmed in the image review.The lumen was not restricted.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

Supplemental report is being submitted due to completion of investigation on 28-apr-2022.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13188760
• MDR Text Key: 294143075
• Report Number: 3001845648-2022-00005
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)240804(10)C1855133
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1855133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2021
• Event Location: Hospital
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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 Sex: Male