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 Ischemia (1942); Vasoconstriction (2126); Restenosis (4576)

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that restenosis occurred.On (b)(6) 2023, a boston scientific pathways rotablator atherectomy device and eluvia was selected to treat the superficial femoral artery with total occlusion through a previously placed stent and reconstitution below hunter's canal in the distal above-knee popliteal artery.The rotablator was used to treat the entire length of the superficial femoral and popliteal arteries to below the knee joint.This was done without complication.The wire was then exchanged for av 18 and a 5 x 200 balloon was used to dilate the entire length of the above-knee popliteal, the entire length of the superficial femoral artery and the entire length of the common femoral artery.Each inflation was taken to nominal pressure with multiple ways noted but complete expansion obtained.Each inflation was held for 3 minutes, deflated and then removed.Repeat angiogram showed the upper portion of the superficial femoral artery to be widely patent and the previously placed stent was widely patent.Below the stent there was a significant dissection and irregularity, so a 6 x 120, 130 cm eluvia drug-eluting vascular stent system was selected to cover 1cm of the previously placed stent down to just above the knee joint.The stent was then post dilated with the 5 x 200 balloon.Repeat angiogram showed wide patency to the superficial femoral and popliteal arteries.Runoff films showed significant vasospasm in the posterior artery.A balloon was selected and passed down to below the ankle and inflated and held for 5 minutes, deflated and then repositioned.After the entire length of the posterior tibia had been balloon dilated and generous amount of nitroglycerin given, the repeat angiogram showed resolution of the spasm with brisk flow now seen distally.These findings were accepted and the sheath was removed.A starclose device deployed at the puncture site, with direct pressure held in excellent hemostasis was obtained.The patient was taken to the recovery area in stable condition.She tolerated the procedure well.On 29february2024, follow-up angiogram revealed left leg revascularization with critical limb threatening ischemia of the left leg.Due to diffuse nature of femoral disease, atherectomy was performed before angioplasty in order to minimize risk of dissection and therefore minimize the need for additional intralingual stenting.A 2.0 rotablator device was used for atherectomy of the left superficial femoral artery, and then balloon angioplasty was performed using 5 mm drug-coated balloon.Completion angiogram performed with satisfactory result.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18987807
• MDR Text Key: 338725675
• Report Number: 2124215-2024-18546
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030153225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White