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

Model Number	G57448
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Stacking Breaths (1593); High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: nio stent, iliac.
Event or Problem 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
• Report Number: 3005580113-2022-00098
• Device Sequence Number: 20114935
• Product Code: NIO
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231016(10)C1768452
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022
• Report Date (Section F): 08/30/2022

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
• Operator of Device: 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
• Distributor Facility Aware Date: 08/01/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2022
• Date Device Manufactured: 10/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/30/2022