MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Codes	Dyspnea (1816); Unspecified Heart Problem (4454)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was difficult to position and stent migration occurred.A 14x120mm, 100cm and a 16x60mm, 100cm vici stent system were selected for use in a procedure on (b)(6) 2021.The patient presented with compression of the left common iliac vein (lciv) and stenosis of the left external iliac vein (leiv) upon obtaining intravascular ultrasound (ivus) images.The reference external iliac vein (eiv) averaged 13mm.The eiv was measured because there was not a place within the confluence that was able to be measured.A 14x120mm vici stent was placed from the common iliac vein (civ) to the distal eiv.Upon deployment, the stent dropped below the civ compression due to the severity of the compression.Only 2cm of the stent was in the confluence.A 16x60mm vici stent was placed above the 14x120mm stent with approximately a 2-3cm overlap into the 14x120mm stent.The stents were post-dilated with a balloon.Ivus images were obtained showing complete apposition to the vein walls.On (b)(6) 2021, the patient went to the emergency department with heart fluttering and shortness of breath.Images were obtained that showed both vici stents had migrated to the right atrium as a unit.The patient was stable and awaiting surgery to remove the vici stents.On (b)(6) 2021, the stents were surgically removed.Post surgery, the patient's chest tubes were removed.The patient was stable and doing well.
Event or Problem Description
It was reported that the stent was difficult to position and stent migration occurred.A 14x120mm, 100cm and a 16x60mm, 100cm vici stent system were selected for use in a procedure on (b)(6) 2021.The patient presented with compression of the left common iliac vein (lciv) and stenosis of the left external iliac vein (leiv) upon obtaining intravascular ultrasound (ivus) images.The reference external iliac vein (eiv) averaged 13mm.The eiv was measured because there was not a place within the confluence that was able to be measured.A 14x120mm vici stent was placed from the common iliac vein (civ) to the distal eiv.Upon deployment, the stent dropped below the civ compression due to the severity of the compression.Only 2cm of the stent was in the confluence.A 16x60mm vici stent was placed above the 14x120mm stent with approximately a 2-3cm overlap into the 14x120mm stent.The stents were post-dilated with a balloon.Ivus images were obtained showing complete apposition to the vein walls.On (b)(6) 2021, the patient went to the emergency department with heart fluttering and shortness of breath.Images were obtained that showed both vici stents had migrated to the right atrium as a unit.The patient was stable and awaiting surgery to remove the vici stents.On (b)(6) 2021, the stents were surgically removed.Post surgery, the patient's chest tubes were removed.The patient was stable and doing well.It was further reported that there was a may-thurner lesion.Additionally, there was a distal external compression and it seemed like a long diffused section of compression.There was noted to be not much normal vein.Initially, the stent did extend to the confluence but once deployed, the stent began to pull back or become squeezed down.This was post-partum treatment after more and more swelling post-birth.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The returned product consisted of a vici stent 14x120mm for vici stent system, 14x120mm, 100cm.The delivery system was not returned for analysis.A visual and microscopic examination found no damage or issues with the returned stent.The dimensions of the stent were confirmed to be 14x120mm using calibrated ruler and found to be within specification as per veniti product specifications and traceability veniti design trace matrix.
Event or Problem Description
It was reported that the stent was difficult to position and stent migration occurred.A 14x120mm, 100cm and a 16x60mm, 100cm vici stent system were selected for use in a procedure on (b)(6) 2021.The patient presented with compression of the left common iliac vein (lciv) and stenosis of the left external iliac vein (leiv) upon obtaining intravascular ultrasound (ivus) images.The reference external iliac vein (eiv) averaged 13mm.The eiv was measured because there was not a place within the confluence that was able to be measured.A 14x120mm vici stent was placed from the common iliac vein (civ) to the distal eiv.Upon deployment, the stent dropped below the civ compression due to the severity of the compression.Only 2cm of the stent was in the confluence.A 16x60mm vici stent was placed above the 14x120mm stent with approximately a 2-3cm overlap into the 14x120mm stent.The stents were post-dilated with a balloon.Ivus images were obtained showing complete apposition to the vein walls.On (b)(6) 2021, the patient went to the emergency department with heart fluttering and shortness of breath.Images were obtained that showed both vici stents had migrated to the right atrium as a unit.The patient was stable and awaiting surgery to remove the vici stents.On (b)(6) 2021, the stents were surgically removed.Post surgery, the patient's chest tubes were removed.The patient was stable and doing well.It was further reported that there was a may-thurner lesion.Additionally, there was a distal external compression and it seemed like a long diffused section of compression.There was noted to be not much normal vein.Initially, the stent did extend to the confluence but once deployed, the stent began to pull back or become squeezed down.This was post-partum treatment after more and more swelling post-birth.It was further reported that the stenosis was 80-90% and there was no predilatation of the lesion however, both stents were post dilated.Both stents migrated to the heart as a single unit.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11717044
• Report Number: 2134265-2021-05194
• Device Sequence Number: 3765514
• Product Code: QAN
• UDI-Device Identifier: 00852725008140
• UDI-Public: 00852725008140
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2021

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: 09/30/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019090016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/04/2021; 05/27/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/24/2021; 06/18/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92672766-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 29 YR