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

Model Number G57448

Device Problem Migration (4003)

Patient Problems Stacking Breaths (1593); High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

Common device name: nio stent, iliac.

Event Description

Per patient's wife he had to have open heart surgery at (b)(6) hospital (c21635-0) because the stent had migrated.He had problems with leg swelling before the stent was implanted.He had high blood pressure after the implant and the leg swelling became worse due to 60 mg of lasix.The device was implanted by dr.(b)(6) at the vascular experts (c43414-0).The doctor thought the patient had a mass but it was the migrated stent.The stent had wrapped around a ventricle causing a minute leak.After explant, it was noticed that the filter never fully opened.Now, the patient was not feeling well/tired and has had anxiety after the explant.After cardiac physical therapy, they put the machine on him and he went into afib.He is not recovering as expected.Did any unintended section of the device remain inside the patient¿s body? not that was reported if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? yes.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.-open heart surgery.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Open heart surgery has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? yes.Please specify adverse effects and provide details.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 15321425
• MDR Text Key: 298903676
• Report Number: 3005580113-2022-00098
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231016(10)C1768452
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1768452
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2022
• Distributor Facility Aware Date: 08/01/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Date Device Manufactured: 10/16/2020
• 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
• Patient Age: 53 YR
• Patient Sex: Male