MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; Stent, iliac vein

Model Number G57448

Device Problem Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stent migration from right common fem to the atrium.Patient is stable and not symptomatic.Information from medwatch report received 01-oct-21: stent that was placed in right cfv (common femoral vein ) was found to have migrated to the patient ' s heart when he came into the hospital for another procedure.He underwent venogram for evaluation of the left iliac venous system when his right common iliac vein stent was observed within the right atrium.Cardiothoracic surgery and cardiology were consulted who recommended evaluation with echocardiography.This was obtained and the patient is now being admitted for observation overnight.

Manufacturer Narrative

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

Event Description

Supplemental report due to updated description on event on 05-oct-21: stent migration from right common fem to the atrium.Patient is stable and not symptomatic.Information from medwatch report received 01-oct-21: stent that was placed in right cfv (common femoral vein ) was found to have migrated to the patient ' s heart when he came into the hospital for another procedure.He underwent venogram for evaluation of the left iliac venous system when his right common iliac vein stent was observed within the right atrium.Cardiothoracic surgery and cardiology were consulted who recommended evaluation with echocardiography.This was obtained and the patient is now being admitted for observation overnight.As per information recieved on 05-oct-21: 4.Are patient demographics available such as age, gender, weight or pre-existing conditions? yes.5.Where any type of interventional procedures performed due to the occurrence? ct removed the stent.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Pma #: p200023.Product code: qan.The zvt7-35-80-16-100 device of lot number c1772420 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.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 c1772420 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 c1772420.It should be noted that stent migration is listed as a known potential adverse event within the instructions for use.There is no evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patients pre-existing condition, pts and scar tissue, which may have exerted high pressure on the stent.This could have contributed to the migration of the stent.The complaint is confirmed based on customer testimony.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient required echocardiography and surgical intervention in order to remove the migrated device from the body.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Pma/510(k) # p200023.Common name- (b)(6).Device evaluation the zvt7-35-80-16-100 device of lot number c1772420 involved in this complaint was implanted in the patient and 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 c1772420 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 c1772420.It should be noted that stent migration is listed as a known potential adverse event within the instructions for use, ifu0091-7.There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patients pre-existing condition, pts and scar tissue, which may have exerted high pressure on the stent.This could have contributed to the migration of the stent.As previously noted stent migration is listed as a known potential adverse event within the instructions for use.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient was stable and not symptomatic.The migration was noted when the patient came to the hospital for another procedure.The patient required echocardiography and surgical intervention in order to remove the migrated device from the body.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental correction report is being submitted following a review of this complaint file.Updates were made to annex e and f codes and investigation evaluation.

• 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: 12596645
• MDR Text Key: 277487321
• Report Number: 3001845648-2021-00718
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231030(10)C1772420
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/10/2021,03/22/2024

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: 10/30/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1772420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 09/10/2021
• Distributor Facility Aware Date: 09/10/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 09/16/2021; 09/16/2021; Not provided
• Supplement Dates FDA Received: 11/03/2021; 02/08/2022; 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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): Life Threatening; Required Intervention