BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Model Number 24653 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Perforation of Vessels (2135); Pseudoaneurysm (2605); Ruptured Aneurysm (4436)
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Event Date 08/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that a pseudoaneurysm occurred and it had ruptured.On (b)(6) 2021, a carbon dioxide contrast was performed to visualize a chronic total occlusion in the right superficial femoral artery (sfa) due to contrast medium shock.Patient anatomy conditions revealed that the lesion was 100% stenosed, had severe calcification and was located in moderately tortuous anatomy.Lesion access was obtained through the left femur using a 6french destination guiding sheath.The lesion was accessed after multiple attempts with non-boston scientific (bsc) guidewires.Pre-dilation of the lesion was performed using 5mm shiden hp balloon.A 7mm x 120mm eluvia was implanted in the proximal section of the sfa ostium.A 5mm x 100mm non-bsc stent was implanted in the mid section of the sfa.However, the stent that was implanted in the distal section became detached.Therefore a 6mm x 120mm eluvia was implanted in the distal section.The blood flow was concluded to be improving, and the procedure was completed.On (b)(6) 2021, a pseudoaneurysm in the 7mm x 120mm eluvia occurred and ruptured.The proximal sfa pseudoaneurysm was confirmed using a non-bsc device and intravascular ultrasound.The aneurysm was completely sealed by implanting a non-bsc stent overlapping the 6mm x 120mm eluvia in the distal section, and another non-bsc stent in proximal section.The entire stent was inflated with a non-bsc balloon.The aneurysm was resolved.There were no patient complications reported.According to the physician, it was presumed that a vessel wall degeneration did not occur.Based on the images taken after implanting the 7mm x 120mm eluvia stent on (b)(6) 2021, there was a possibility that the contrast medium may have leaked.It was implied that the bleeding from that event might have caused the rupture of the pseudoaneurysm that was observed on (b)(6) 2021.
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Manufacturer Narrative
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E1.Initial reporter phone and initial reporter fax updated with correct information.E1.Initial reporter facility name: (b)(6) medical center.H6.Patient codes were updated.
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Event Description
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It was reported that a pseudoaneurysm occurred and it had ruptured.On (b)(6) 2021, a carbon dioxide contrast was performed to visualize a chronic total occlusion in the right superficial femoral artery (sfa) due to contrast medium shock.Patient anatomy conditions revealed that the lesion was 100% stenosed, had severe calcification and was located in moderately tortuous anatomy.Lesion access was obtained through the left femur using a 6french destination guiding sheath.The lesion was accessed after multiple attempts with non-boston scientific (bsc) guidewires.Pre-dilation of the lesion was performed using 5mm shiden hp balloon.A 7mm x 120mm eluvia was implanted in the proximal section of the sfa ostium.A 6mm x 150mm non-bsc stent was implanted in the mid section of the sfa.However, a slight dissection and rupture-like contrast were seen in the distal section when advancing the 5mm x 100mm lutonix drug coated balloon for post-inflation.As a result, a 6mm x 120mm eluvia was implanted in the distal section.The blood flow was concluded to be improving, and the procedure was completed.On (b)(6) 2021, a pseudoaneurysm in the 7mm x 120mm eluvia occurred and ruptured.The proximal sfa pseudoaneurysm was confirmed using a non-bsc device and intravascular ultrasound.The aneurysm was completely sealed by implanting a non-bsc stent overlapping the 6mm x 120mm eluvia in the distal section, and another non-bsc stent in proximal section.The entire stent was inflated with a non-bsc balloon.The aneurysm was resolved.The patient was hospitalized for two weeks while recovering from the pseudoaneurysm and was discharged safely.There were no patient complications reported.According to the physician, it was presumed that a vessel wall degeneration did not occur.Based on the images taken after implanting the 7mm x 120mm eluvia stent on (b)(6) 2021, there was a possibility that the contrast medium may have leaked.It was implied that the bleeding from that event might have caused the rupture of the pseudoaneurysm that was observed on (b)(6) 2021.
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