MAUDE Adverse Event Report: COOK MEDICAL LLC. ZILVER VENA; STENT, ILIAC VEIN

Model Number ZVT7-35-80-16-100

Device Problems Difficult or Delayed Positioning (1157); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2021

Event Type  Injury  

Event Description

Multiple 2d imaging of the entire right iliac vein was performed demonstrating that the stent placed at the right external iliac vein had migrated into the proximal ivc post venoplasty.Since the distal end of the wire was still at the common femoral vein, we prepared for retrieval procedure.In order to have better access to the inferior vena cava the right groin area was prepped to access the right common femoral vein.While patient was still sedated the right groin was prepped and draped in sterile fashion.The right common femoral vein was then identified with limited ultrasound images and access with an 18 ga.Needle then followed by a.035 glide wire, then the needle was removed/replaced with a 10 fr.Sheath.The guide wire was then managed within the migrated stent at the proximal ivc for security purposes (maintaining the wires within the stent in order to prevent stent migration into the atrium).A 16mm x 60mm atlas bard balloon catheter was placed through the right ij access site and advanced at the proximal end of the stent over the wire, then the balloon was inflated up to 4 atm's and gently pushed under fluoro guidance until the distal end of the stent was within the proximal right common iliac vein confluence.Once the stent was placed at a satisfactory location the balloon was fully deflated and at this point the stent migrated once again over the deflated stent stopping at the level of the ivc/svc junction.The same process was repeated at least 4 times with the same result then the same procedure was duplicated now through the femoral access at least in four different occasions with the same results.Finally an 18mm x 60mm atlas bard balloon was placed through the right ij access and a 16 mm x 60mm atlas bard balloon through the right femoral access, then after inflating both balloons simultaneously one within the stent (femoral access) and the second one proximal to the proximal end of the stent (right ij access).Once both balloons were inflated, the balloon within the stent was pulled as the balloon at the right ij was pushed simultaneously until the distal end of the stent was placed within the proximal end of the right common iliac vein.Once the 16mm x 100mm zilver vena cook stent was retracted as much as possible into the common iliac vein, the balloon through the femoral access within the stent was fully deflated and exchanged for an 18 mm x 100 mm medtronic abre venous stent.The stent was then advanced over the wire and placed at least 4 cm within the distal aspect of the cook stent while maintaining the proximal balloon fully inflated in order to prevent stent migration while second stent was deployed under fluoroscopic surveillance.Once the abre stent was successfully deployed, the stent deployment system was then replaced with an 18 mm x 60mm atlas gold bard balloon.The balloon was then placed at the level of the proximal end of both stents and venoplasty was accomplished for at least 30 seconds to a maximum of 10 atm's.Venoplasty was performed to the area of stents overlapped and to the distal end of the stents for up to 30 seconds each time to a maximum of 8 atm's.Both balloons were deflated and discontinued from the access sites, and the ivus catheter was then advanced through the femoral access site while maintaining access through both sites and with the wire still in place.Fda safety report id# (b)(4).

• Brand Name: ZILVER VENA
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK MEDICAL LLC.; bloomington IN 47404
• MDR Report Key: 13417005
• MDR Text Key: 284979058
• Report Number: MW5107095
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZVT7-35-80-16-100
• Device Catalogue Number: G57448
• Device Lot Number: C1851669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 16MM X 60MM ATLAS BARD BALLOON CATHETER; 18 MM X 100 MM METRONIC ABRE VENOUS STENT; 18MM X 60MM ATLAS BARD BALLOON CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White