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

Model Number 24657

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

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that thrombosis and occlusion occurred.On (b)(6) 2021, following an atherectomy procedure, imaging showed a patent but small flow channel in the left superficial femoral artery (sfa).Balloon angioplasty was performed to the entire sfa with a 5 x 250 mm balloon inflated to full profile for 3 minutes using 2 overlapping inflations.Repeat imaging showed a good result with the exception of a significant residual stenosis at the level of the distal occlusion cap.An additional 5 minute inflation was performed with the 5 mm balloon.No significant improvement was seen during repeat imaging.Therefore, a 6x60, 130 cm eluvia drug-eluting vascular stent system was selected to be deployed in the left sfa in standard fashion.Final imaging of the target lesion showed no significant residual stenosis, brisk flow through the femoral-popliteal system and preserved runoff.The patient tolerated the procedure and was taken to recovery in good condition.On (b)(6) 2022, during index procedure, it was noted that the superficial femoral artery was occluded at its origin.Using roadmap imaging, a non-boston scientific guidewire and a rubicon crossing catheter were advanced through the occluded sfa.Upon reaching the stent and the below-knee popliteal artery, the wire and catheter advanced easily, indicating fairly fresh thrombus.The intraluminal position was confirmed by catheter injection, and a non-boston scientific embolic protection device was deployed in the below-knee popliteal artery.Atherectomy of the sfa was then performed in the blades down position using a 2.1/3.0 mm jetstream atherectomy device.A second pass was performed in the blades down position, but the device became difficult to advance in the mid sfa.The catheter ruptured just outside of the sheath, so the device was removed.Balloon angioplasty was then performed in the above-knee popliteal and superficial femoral arteries with a ranger 5 x 200 mm drug-eluting balloon catheter.Repeat imaging showed the sfa and the above-knee popliteal arteries to be widely patent but with sluggish flow.There appeared to be stenosis in the below-knee popliteal artery, so balloon angioplasty was performed in the below-knee popliteal artery with an inflation of 3 minutes.Repeat imaging showed great improvement.Final imaging showed a good result with no significant residual stenosis and relatively brisk flow to the foot through preserved runoff.The patient tolerated the procedure well and was taken to recovery in good condition.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13933297
• MDR Text Key: 288097623
• Report Number: 2134265-2022-03404
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027288161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White