MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Model Number G57449

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: p200023.Product code: qan.

Event Description

A patient of undisclosed gender and age underwent an undisclosed procedure in which the zilver vena venous self-expanding stent, g57449, was used.The stent was deployed in a tight lesion.When deployed the stent stretched to 200 cm from a 160cm length.When it deployed it went into the tissue tract of the patient.The patient was transferred from the facility to the hospital with an emergent procedure.Patient outcome: 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? no; if yes, please describe.Did the product cause or contribute to the need for additional procedures? no; if yes, please specify additional procedures and provide details.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.

Manufacturer Narrative

Product code - qan.Common name - qan.Pma/510(k) # p200023.

Event Description

Supplemental report required to update event description with additional information received on 19-nov-21: the doctor did not observe the stent detach from the delivery catheter (rushing) and pulled the stent and stretched it.The patient had to go to the hospital for emergency removal of the stent.

Manufacturer Narrative

Pma/510(k) # p200023.Common name - qan.Product code - qan.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the confirmation received from eng on (b)(6) 2022 that it would be considered user error if the doctor was rushing and did not observe the stent detach from the delivery system in turn stretching the stent when pulled.

Manufacturer Narrative

Pma/510(k) #p200023.Device evaluation user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The zvt7-35-80-16-140 device of lot number c1771926 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The file is related to (b)(4)./ mdr ref#3001845648-2023-00543 which was raised to capture the incorrect size access sheath used.Manufacturing records.Prior to distribution all zvt7 devices are subjected to a visual inspection and functional inspection to ensure device integrity a review of the manufacturing records for zvt7-35-80-16-140 of lot number c1771926 did not reveal any discrepancies that could have contributed to this complaint issue.An nc (gen-111) was noted on the work order, however this was subsequently scrapped and would not have attributed to this complaint issue.Review historical data.The review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/or label.It should be noted that the instructions for use, ifu0091, states the following: ¿ensure the handle remains in a stabilized position while deploying the stent.Tension to remove the slack outside the patients body should be applied; however, do not apply excessive tension on the system as stretching of the stent may occur.Once stent deployment has begun, the stent must be fully deployed¿.There is evidence to suggest the user did not follow the ifu.Image review.An image was not returned for evaluation.Root cause review.A definitive root cause of user error was determined from the available information.Based on the available information, it is known that the user did not observe the deployed stent detach from the delivery system due to rushing.When the physician then attempted to withdraw the delivery system, tension was placed on the system which resulted in the stent getting pulled and becoming stretched.As per the instructions for use ¿ensure the handle remains in a stabilized position while deploying the stent.Tension to remove the slack outside the patients body should be applied; however, do not apply excessive tension on the system as stretching of the stent may occur.Once stent deployment has begun, the stent must be fully deployed¿.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Summary.According to the initial reporter when deployed, the stent stretched to 200 cm from a 160cm length.When it deployed it went into the tissue tract of the patient.The doctor did not observe the stent detach from the delivery catheter (rushing) and pulled the stent and stretched it.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient required surgical intervention to remove the stent.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of ifu.From the information available it is known that the doctor did not observe the stent detach from the delivery catheter due to rushing and pulled the stent and stretched it.As per ifu ¿'ensure the handle remains in a stabilized position while deploying the stent.Tension to remove the slack outside the patients body should be applied; however, do not apply excessive tension on the system as stretching of the stent may occur.Once stent deployment has begun, the stent must be fully deployed¿.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 22-sep-23.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: STENT, ILIAC VEIN
• 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: sinead o'leary ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12533636
• MDR Text Key: 273367240
• Report Number: 3001845648-2021-00701
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)231029(10)C1771926
• 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,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1771926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 09/01/2021; 09/01/2021; 09/01/2021
• Supplement Dates FDA Received: 12/15/2021; 02/16/2022; 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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 Outcome(s): Required Intervention