MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Thrombosis (2100)

Event Date 01/14/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that a stent fracture occurred.On (b)(6) 2015 the subject was enrolled in the (b)(6) study due to due to post-thrombotic etiology and on the same day, index procedure was performed.The target lesion was located in the left common iliac vein extending to external iliac vein with 100% stenosis and was 190 mm long with a shortest diameter of 0 mm by venogram and 0 mm by intravascular ultrasound (ivus).Treatment was performed with placement of a 16 mm by 120 mm first study stent in the common iliac vein extending to external iliac vein and a 16 mm by 120 mm second study stent in the external iliac vein extending to common femoral vein (cfv) in an overlapping manner with 15 % residual stenosis by venogram and 13 % residual stenosis by ivus.Of note, cfv was not considered as target lesion although study stent extended into cfv as percentage stenosis was less than 50 %.On the same day, subject was discharged on anticoagulant/antiplatelet regimen.On (b)(6) 2020 the subject visited the hospital for 48- months follow up and stated that he had worsening of left lower extremity pain and swelling over the last three months.Subsequently, duplex ultrasound was performed which revealed: chronic, non-occlusive deep vein thrombosis within the left common and external iliac vein stents and left common femoral and proximal femoral veins.Patent and clear inferior vena cava, right common iliac vein and external iliac veins was noted.It was noted that the left external iliac vein stenosis was a new finding compared to the previous exam performed on (b)(6) 2019.Based on the above findings, the subject was planned for further evaluation and treatment in later days.On (b)(6) 2020, venogram was performed which demonstrated area of external iliac vein patent and 90% in-stent thrombotic stenosis in the remaining external iliac vein and the stent in the external iliac vein was also noted to be fractured.There was area of common iliac vein patent and 50% in-stent stenosis noted in the remaining common iliac vein.Subsequently, ivus was performed which revealed: patent common external iliac vein and common femoral vein stents, however, there was an area of stent fracture and almost 100% tight stenosis noted at the level of the terminal external iliac vein.There was stenosis throughout the common iliac vein and common femoral vein stents.The terminal common femoral vein below the level of the stent was noted to be completely normal.On (b)(6) 2020, stenosis noted in the common femoral vein, external iliac vein and common femoral vein was initially pre-dilated with 16 x 4 balloon.Post ballooning, a 16 mm x 100 mm non-bsc stent was stented within the existing stents in the common iliac vein and external iliac vein.Post stenting, balloon angioplasty was performed with dilation to 16 mm within the old stent in the common femoral vein.Post procedure, completion venogram and completion ivus was performed which showed an excellent technical result with no gap between the stents and no apparent flow defect inside the new stent core lab x-ray dated (b)(6) 2016 revealed one stent fracture.12 month follow up, x-ray dated (b)(6) 2016 revealed type 4 stent fracture.On (b)(6) 2020, the event was considered resolved.

Manufacturer Narrative

Date of event was updated from (b)(6) 2016 to (b)(6) 2020.Device code updated from fracture to adverse event without identified device or use problem.

Event Description

Virtus clinical study: it was reported that a stent fracture occurred.On (b)(6) 2015 the subject was enrolled in the virtus clinical study due to due to post-thrombotic etiology and on the same day, index procedure was performed.The target lesion was located in the left common iliac vein extending to external iliac vein with 100% stenosis and was 190 mm long with a shortest diameter of 0 mm by venogram and 0 mm by intravascular ultrasound (ivus).Treatment was performed with placement of a 16 mm by 120 mm first study stent in the common iliac vein extending to external iliac vein and a 16 mm by 120 mm second study stent in the external iliac vein extending to common femoral vein (cfv) in an overlapping manner with 15 % residual stenosis by venogram and 13 % residual stenosis by ivus.Of note, cfv was not considered as target lesion although study stent extended into cfv as percentage stenosis was less than 50 %.On the same day, subject was discharged on anticoagulant/antiplatelet regimen.On (b)(6) 2020 the subject visited the hospital for 48- months follow up and stated that he had worsening of left lower extremity pain and swelling over the last three months.Subsequently, duplex ultrasound was performed which revealed: chronic, non-occlusive deep vein thrombosis within the left common and external iliac vein stents and left common femoral and proximal femoral veins.Patent and clear inferior vena cava, right common iliac vein and external iliac veins was noted.It was noted that the left external iliac vein stenosis was a new finding compared to the previous exam performed on (b)(6) 2019.Based on the above findings, the subject was planned for further evaluation and treatment in later days.On (b)(6) 2020, venogram was performed which demonstrated area of external iliac vein patent and 90% in-stent thrombotic stenosis in the remaining external iliac vein and the stent in the external iliac vein was also noted to be fractured.There was area of common iliac vein patent and 50% in-stent stenosis noted in the remaining common iliac vein.Subsequently, ivus was performed which revealed: patent common external iliac vein and common femoral vein stents, however, there was an area of stent fracture and almost 100% tight stenosis noted at the level of the terminal external iliac vein.There was stenosis throughout the common iliac vein and common femoral vein stents.The terminal common femoral vein below the level of the stent was noted to be completely normal.On (b)(6) 2020, stenosis noted in the common femoral vein, external iliac vein and common femoral vein was initially pre-dilated with 16 x 4 balloon.Post ballooning, a 16 mm x 100 mm non-bsc stent was stented within the existing stents in the common iliac vein and external iliac vein.Post stenting, balloon angioplasty was performed with dilation to 16 mm within the old stent in the common femoral vein.Post procedure, completion venogram and completion ivus was performed which showed an excellent technical result with no gap between the stents and no apparent flow defect inside the new stent core lab x-ray dated (b)(6) 2016 revealed one stent fracture.12 month follow up, x-ray dated 20-dec-2016 revealed type 4 stent fracture.On january 23, 2020, the event was considered resolved.It was further reported that the stent fracture occurring on 20-dec-2016 was previously reported under report # 2134265-2019-07397.Only one stent was fractured.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 10570567
• MDR Text Key: 208145624
• Report Number: 2134265-2020-13085
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0015040005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR