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

Model Number	G57448
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name - qan.
Event or Problem Description
Per rep - (b)(6) 2021 - the stent elongated upon deployment.They had to put another shorter stent inside the first stent.The procedure was completed successfully.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.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.General questions for complaint occurring during use, request the following: where was the access site? left common femoral vein.What was the patient¿s anatomy? (i.E.Scarred, tortuous, calcified, etc.) calcified.What was the target location for the stent? common iliac vein.Was the target location severely calcified or tortuous? calcified.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? yes.Physician met with quite a bit of resistance upon unsheathing/delivering the stent.Was the stent fully deployed before removing the delivery system from the patient? yes.What other devices were used in the procedure?.035 cook roadrunner uniglide wire, 9 fr sheath.Please provide manufacturer, model, brand, and size if possible.035 cook roadrunner uniglide wire, 9 fr sheath.Were any additional procedures necessary as a result of this event? no.Can any photos, images, or reports of the procedure or device be provided? the device and photos will be provided.Please review following ¿failure¿ modes with contact to determine if additional questions apply.If the event involves thrombosis, restenosis, and/or occlusion, request the following: n/a.Did the patient have any risk factors for thrombosis, restenosis, or occlusion? what other medications and/or treatments was the patient receiving? if occlusion occurred, can it be confirmed if the occlusion is related to thrombosis or restenosis? if the event involved claudication / pain, request the following: n/a.Is the reported event a symptom of restenosis or thrombosis? if no restenosis or thrombosis occurred how it was determined that the zilver stents caused / contributed to the event? if the event involves stent shortening, request the following: n/a.Was there any evidence of post deployment stent compression or deformation? was the delivery system able to be advanced to the target site easily / with no resistance? was the handle pulled toward the hub while the delivery system remained stationary during deployment? if the event involves sheath separation, request the following: n/a.Was there high resistance encountered during any part of the procedure, wire guide advancement, stent deployment, etc.? was pre-dilatation conducted prior to stent deployment? was the handle puled toward the hub while the delivery system remained stationary during deployment? if the event involving deployment difficulties, request the following: was the stent eventually deployed? yes.Was pre-dilatation conducted before stent deployment? yes.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? unkr.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11959214
• Report Number: 3005580113-2021-00067
• Device Sequence Number: 3789648
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231005(10)C1765208
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2021
• Report Date (Section F): 06/07/2021

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: 10/05/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1765208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention