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Model Number 26930 |
Device Problem
Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that stent migration occurred.A 16 x 60mm x 100cm vici self-expanding stent was selected for use in the right iliac vein.A venogram and intravascular ultrasound (ivus) were used to image the lesion prior to stent implantation.There was no significant lesion or obstruction present, and the physician opted to stent based on symptoms alone.The reference vessel was 14mm and the stent was upsized by 2 mm.The stent was implanted without any difficulties and a balloon was used for post-dilation.Upon deployment, ivus was performed showing a well apposed stent and patent lumen.However, on the same day, after the patient was discharged, the stent migrated to the heart.The patient condition was stable, and the patient returned to the hospital where intervention was performed.The stent was retrieved and removed from the heart.
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Manufacturer Narrative
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A2 - age at time of event: 18 years or older.
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Event Description
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It was reported that stent migration occurred.A 16 x 60mm x 100cm vici self-expanding stent was selected for use in the right iliac vein.A venogram and intravascular ultrasound (ivus) were used to image the lesion prior to stent implantation.There was no significant lesion or obstruction present, and the physician opted to stent based on symptoms alone.The reference vessel was 14mm and the stent was upsized by 2 mm.The stent was implanted without any difficulties and a balloon was used for post-dilation.Upon deployment, ivus was performed showing a well apposed stent and patent lumen.However, on the same day, after the patient was discharged, the stent migrated to the heart.The patient condition was stable, and the patient returned to the hospital where intervention was performed.The stent was retrieved and removed from the heart.It was further reported that the patient was treated due to symptomatic may-thurner on the left side.There was approximately an 85% focal compression on the left side.A vici stent was placed with no issues.A 16x60mm stent was also placed on the right side based on the patient symptoms.There was no compression and no identifiable lesion to treat.The landing zones were measured via ivus to be approximately 14mm.The 16x60 vici stent placed on the right side landed well below the ivc-civ confluence and entirely in the iliac vein.Both vici stents expanded as expected and were post-dilated with a balloon.Post-discharge (same day), the patient was readmitted and transferred to another hospital as the stent from the right iliac had migrated to the heart.The stent was removed from the heart.
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Search Alerts/Recalls
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