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

Model Number	G57449
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name - qan.Product code - qan.
Event or Problem Description
According to the initial reporter: a female patient in her 60s with compression of the common iliac and external iliac veins on right side underwent an ivus and venography procedure in which the zilver vena venous self-expanding stent, g57449 and g57448, were used.Access site was right groin and a ivus and venography was performed.The physician selected 16x140 vena to stent from the confluence into the external iliac vein on right side.No predilation was done.After deploying stent optimally, physician advanced a (another manufacturer's) 16x60 balloon into the stent.The tech who was scrubbed in states the physician was not stepping on fluoro while advancing balloon, and once he did step on fluoro both the physician and tech saw that the stent had almost completely, about 95%, migrated into the patient¿s ivc (subject of this report).They both agreed that the balloon catheter bumped the caudal edge of the stent and caused it to migrate significantly.Physician attempted to use the bard atlas balloon to pull the stent back down into the common iliac, but was unsuccessful.Then, physician deployed another 16x140 vena into common iliac, overlapping the 2 stents a few centimeters.Due to stent migration, a third stent, the 16x100, was needed to extend into the external iliac.Physician used same 16x60 atlas balloon to post dilate the stents, and as he was advancing the balloon into the 16x100 stent, the balloon bumped into this stent also and caused it to jump about 2 cm but was able to use the balloon to pull the stent back down to original landing zone (ref: (b)(4).

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14854479
• Report Number: 3005580113-2022-00070
• Device Sequence Number: 5245515
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)250202(10)C1910129
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2022
• Report Date (Section F): 06/29/2022

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: 02/02/2025
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1910129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2022
• Date Device Manufactured: 02/02/2022
• 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 Sex: Female
• Date Report Sent to FDA: 06/29/2022