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

Model Number G57455

Device Problem Migration (4003)

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

Event Date 03/14/2022

Event Type  malfunction  

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

Per rep - on (b)(6) 2022 - the doctor said that, when he landed the stent, it moved up a little bit into the ivc.He did not like they way it deployed.The procedure was successfully completed with the device in question.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 due to this occurrence? 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.Prefix zvt7.Are images of the device or procedure available? n/a, yes, no -no.Did the patient have pre-existing conditions? n/a, yes, no -unkr if yes, please specify.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other -vein anatomy was not uncommon.If other, please specify.Was a stent previously placed during previous procedures? n/a, yes, no.Was the device used percutaneously? n/a, yes, no.Where on the patient was the percutaneous access site? -right groin.Was the access site jugular or femoral? n/a, jugular, femoral other -femoral if other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? -iliac vein being treated.If other, please specify was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral -ipsilateral.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no.What was the target location for the stent? -iliac vein details of access sheath used (name, fr size, length)? unkr.Was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no.Details of the wire guide used (name, diameter, hydrophylic)? was resistance encountered when advancing the wire guide to the target location? n/a, yes, no.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.If resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? n/a, yes, no.Did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no.Did the user push the hub during deployment? n/a, yes, no.Did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no.Was the stent deployed smoothly / without resistance? n/a, yes, no.Was the stent fully deployed in the patient? n/a, yes, no.Was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no.Was post dilation performed after the placement of the stent? n/a, yes, no.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no not that was reported.What intervention (if any) was required? none.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day no secondary procedure.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no disposed of by customer please specify if yes.

Manufacturer Narrative

Pma/510(k) # p200023.Product code - qan.Device evaluation: the zvt7-35-120-16-140 device of lot number c1852095 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.Lab evaluation - the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: prior to distribution zvt7-35-120-16-140 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zvt7-35-120-16-140 of lot number c1852095 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 c1852095.It should be noted that the instructions for use (ifu0091) states the following: ¿potential adverse effects ¿ stent migration¿.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 product handling from the delivery system adjustment before deployment or the stent could have migrated due to post-dilation as per engineering input.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.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 14081848
• MDR Text Key: 298629193
• Report Number: 3001845648-2022-00213
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574554
• UDI-Public: (01)10827002574554(17)240721(10)C1852095
• 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
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57455
• Device Catalogue Number: ZVT7-35-120-16-140
• Device Lot Number: C1852095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2022
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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