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

Model Number G57453

Device Problem Migration (4003)

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

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As initially reported to customer relations: a patient of unspecified gender and age underwent an unspecified procedure previously in which the zilver vena venous self-expanding stent, g57453, was used.On (b)(6) 2023 it was noted that the stent had migrated into the patient's heart.The patient is doing okay.Updated information: noted during other procedure, ultrasound done at 1 month and 6 months and these images can be shared.Additional information received (b)(6) 2023: additional questions answered.Incorrect size access sheath used.Additional file requested.Patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? yes.If yes, please describe.Stent in right atrium across valve.2.Was the patient hospitalized or was there prolonged hospitalization? will be hospitalized for procedure to remove device, date yet to be determined.3.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Yes, will require sternotomy to remove device.4.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Yes, will require sternotomy to remove device.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no patient was asymptomatic, but patient will need to have open surgery to remove stent.6.Has the complainant reported that the product caused or contributed to the adverse effects? yes, because patient will need sternotomy to remove stent in right atrium please specify adverse effects and provide details.Patient/event info - notes: prefix zvt7 3.91 are images of the device or procedure available? yes 3.92 did the patient have pre-existing conditions? yes ¿ if yes, please specify: history of htn, afib, varicose veins, may thurner, anxiety 3.93 please describe the native state of the vessel (i.E.Was the anatomy tortuous? not tortuous was the vessel fibrotic?) no ¿ if other, please specify: 3.94 was a stent previously placed during previous procedures? no 3.95 was the device used percutaneously? yes 3.96 where on the patient was the percutaneous access site? left femoral vein 3.97 was the access site jugular or femoral? n/a, jugular, femoral other ¿ if other, please specify: left femoral vein 3.98 what disease pathology was being treated? may thurner ¿ if other, please specify 3.99 was the lesion approached via contralateral or ipsilateral? ipsilateral 3.100 was pre-dilation performed ahead of placement of the stent? yes predilated with 14 balloon 3.101 what was the target location for the stent? left common iliac vein 3.102 details of access sheath used (name, fr size, length)? 9fr x 11cm super sheath 3.103 was the device flushed through both flushing ports before the procedure, as per ifu? yes 3.104 details of the wire guide used (name, diameter, hyrdophyllic)? emerald j wire, 035x150cm 3.105 was resistance encountered when advancing the wire guide to the target location? no 3.106 was resistance encountered when advancing the delivery system to the target location? no 3.107 if resistance was met, how did the physician address this? n/a 3.108 did the tip of the delivery system cross the target location? yes 3.109 did the user pull the handle towards the hub during deployment, per ifu? yes 3.110 did the user push the hub during deployment? no 3.111 did the user remove slack in the delivery system before deployment, per ifu? yes 3.112 was the stent deployed smoothly / without resistance? yes 3.113 was the stent fully deployed in the patient? yes 3.114 was the stent fully deployed before removing the delivery system from the patient? yes 3.115 was post dilation performed after the placement of the stent? no; evaluated under ivus with good wall apposition 3.116 was the delivery system damaged/kinked/twisted during deployment? no 3.117 what intervention (if any) was required? none 3.118 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? another day 3.119 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a please specify if yes additional information received 16-may-2023.***district manager response received on 12may2023 regarding follow up procedure and images: th (b)(6) 2023 i [district manager] spoke to [the physician] today and there isn¿t a follow up procedure scheduled yet, and she [physician] mentioned she may not be the one doing the procedure.She [physician] has images but we had a very busy day and she [physician] was working with one of the nurses there to figure out how to send them securely.I [district manager} will follow up with her [physician] next week to see if she [physician] was able to do so.

Manufacturer Narrative

Pma/510(k) #p200023.Device evaluation: the zvt7-35-120-16-60 device of lot number c1824523 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.This file is related to (b)(4) / mdr#3001845648-2023-00425- user error: incorrect size access sheath.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed 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: the instructions for use ifu0091 which accompanies this device, informs the user, that stent migration is listed as a potential adverse event of this device.It also states ¿determine the proper stent size after complete diagnostic evaluation.Note: selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: images were not returned for evaluation.It was asked of the user if images were available to which they replied that there was but after numerous requests, none were acquired.Should these images become available for review at a later date, the file will be re-opened and re-assessed accordingly.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause of stent migration into the heart could be potentially attributed to inappropriate stent size selection which may have led to stent migration.An image review would be required to confirm this but as of yet, images have not been submitted for review.If images become available, the file can be updated accordingly.As previously mentioned, the ifu lists stent migration as a potential adverse event.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter, a patient of unspecified gender and age underwent an unspecified procedure previously in which the zilver vena venous self-expanding stent, g57453, was used.On april 24, 2023 it was noted that the stent had migrated into the patient's heart.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient will need to have open surgery to remove the stent.Investigation findings conclude a definitive root cause was not established.A possible root cause could likely be attributed to an inappropriate stent size selection.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 25-mar-2024.

• 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
• MDR Report Key: 16972870
• MDR Text Key: 315840540
• Report Number: 3001845648-2023-00382
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574530
• UDI-Public: (01)10827002574530(17)240428(10)C1824523
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: G57453
• Device Catalogue Number: ZVT7-35-120-16-60
• Device Lot Number: C1824523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2023
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 34 KG