MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Pseudoaneurysm (2605); Ruptured Aneurysm (4436)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12866566
• MDR Text Key: 281199351
• Report Number: 2134265-2021-14605
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization