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

Model Number 24657

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier - (b)(6).A2: age at time of event - 65 years old at the time of study enrollment.

Event Description

Elegance clinical trial.It was reported that the delivery system jammed, and the stent elongated.The subject underwent treatment with the eluvia drug eluting stent and ranger drug coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left distal superficial femoral artery (sfa) extending up to left proximal popliteal artery with 5.0 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 132 mm and 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, lithotripsy was performed with shockwave lithotripsy device and pre-dilation was performed using a 2.5 mm x 150 mm coyote pta balloon.Treatment of target lesion was performed by dilation using study device of size 5 mm x 200 mm and 6 mm x 80 mm ranger drug-coated balloons.A dissection of grade e was noted in the left femoropopliteal junction due to the 5 mm x 200 mm ranger drug coated balloon.In response to the dissection, a 6 mm x 120 mm eluvia drug eluting stent was placed in the left distal sfa extending to popliteal artery.During deployment of the eluvia drug-eluting stent, the stent delivery system became jammed, and the stent was deployed in a slightly elongated fashion in its mid segment.The stent was post dilated using a 5 mm x 20 mm sterling balloon.Post treatment, the final residual stenosis was noted to be 30%.On 17-mar-2023, the subject was discharged from the hospital on dual antiplatelet therapy.

• 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: 17735639
• MDR Text Key: 323275886
• Report Number: 2124215-2023-49835
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0029503938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White