MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent migrated.A 16x120mm, 100cm vici was selected for use.The patient had significant compression bilaterally, and it was planned to treat bilaterally.During the entire procedure, the patient was noted to be non-compliant and was continuously moving, which caused difficulty.There were two venous access points at the groin.A venogram was performed, and intravascular ultrasound (ivus) was used to help size the stent.Measurements were performed, which indicated that a 16x120mm vici stent was appropriate.The compression area was approximately 68mm squared: 7.1mm x 11.5mm at the min and max diameters.The compressed lesion area was 8mm.The reference vein diameter central to the compression was approximately 170mm squared: 10.6mm x 20.4mm at the min and max diameters.The healthy portion of the vein was approximately 15mm average diameter.The reference vein diameter proximal to the compression was approximately 146mm squared: 10mm x 14mm at the min and max diameters.The stent was deployed successfully and placed as intended.Immediately after deployment, the patient moved and bore down.The wire moved back.Post-ballooning had not yet been performed.The ivus catheter was advanced in order to image and re-advance the wire.Upon physician review with ivus, it was noted that the distal end of the stent had moved from the distal common iliac to level with the l2 vertebra.The stent migrated up into the inferior vena cava.The patient was stable, but the stent was tacked down, and the patient was transferred to another facility for further treatment.Upon transfer to another facility, a partner physician confirmed with a wire that the stent would not migrate to the heart and then went in through the right jugular down to snare and retrieve the stent.Through the jugular again, the previous lesion measurements were confirmed, and another 16x120mm vici stent was placed successfully.It was noted that the case went well, and there was good apposition.The patient was doing well.The physician believes this was a patient issue (patient noncompliance, movement, and bearing down) that caused the stent to migrate.While it could not be confirmed, there was also discussion of potential interaction of the wire and/or ivus catheter with the stent when the patient moved.
Event or Problem Description
It was reported that the stent migrated.A 16x120mm, 100cm vici was selected for use.The patient had significant compression bilaterally, and it was planned to treat bilaterally.During the entire procedure, the patient was noted to be non-compliant and was continuously moving, which caused difficulty.There were two venous access points at the groin.A venogram was performed, and intravascular ultrasound (ivus) was used to help size the stent.Measurements were performed, which indicated that a 16x120mm vici stent was appropriate.The compression area was approximately 68mm squared: 7.1mm x 11.5mm at the min and max diameters.The compressed lesion area was 8mm.The reference vein diameter central to the compression was approximately 170mm squared: 10.6mm x 20.4mm at the min and max diameters.The healthy portion of the vein was approximately 15mm average diameter.The reference vein diameter proximal to the compression was approximately 146mm squared: 10mm x 14mm at the min and max diameters.The stent was deployed successfully and placed as intended.Immediately after deployment, the patient moved and bore down.The wire moved back.Post-ballooning had not yet been performed.The ivus catheter was advanced in order to image and re-advance the wire.Upon physician review with ivus, it was noted that the distal end of the stent had moved from the distal common iliac to level with the l2 vertebra.The stent migrated up into the inferior vena cava.The patient was stable, but the stent was tacked down, and the patient was transferred to another facility for further treatment.Upon transfer to another facility, a partner physician confirmed with a wire that the stent would not migrate to the heart and then went in through the right jugular down to snare and retrieve the stent.Through the jugular again, the previous lesion measurements were confirmed, and another 16x120mm vici stent was placed successfully.It was noted that the case went well, and there was good apposition.The patient was doing well.The physician believes this was a patient issue (patient noncompliance, movement, and bearing down) that caused the stent to migrate.While it could not be confirmed, there was also discussion of potential interaction of the wire and/or ivus catheter with the stent when the patient moved.It was further reported that the patient was morbidly obese and a lot of respiratory variation.The physician did not perform venography for implantation.The physicians intent was to deploy kissing stents in the common iliac vein.The right stent was deployed first.When the physician proceeded to deploy the left stent, the stent on the right migrated.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11315397
• Report Number: 2134265-2021-01484
• Device Sequence Number: 2713040
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 06/22/2021

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: 10/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019100019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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: Required Intervention