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

Model Number 24657

Device Problems Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an eluvia drug-eluting vascular stent system with a non-boston scientific sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the proximal inner was separated 163.9 cm from the tip.The proximal section was still attached to the clip.The middle sheath appears to be separated at the retainer.There are multiple kinks to the outer sheath, middle sheath, inner liner, and proximal inner, and multiple buckled areas to the outer sheath.The pull rack was separated at the handle.Microscopic examination revealed no additional damages.Part of the stent was visible protruding out of the sheath.X-ray of the sheath revealed that the stent was separated and only the proximal section of the stent was inside the sheath.Another x-ray of the handle confirmed that the middle sheath was separated from the retainer.Product analysis found damage that confirms the issues reported from the field.

Event Description

It was reported that the stent fractured.A 6x150, 130 cm eluvia drug-eluting vascular stent system was selected to treat peripheral arterial disease of the lower leg extremity.The target vessel was an extremely calcified with a previous bypass graft that had gone down.The eluvia 6x150x130 was placed in the sheath over the wire.Up and over the bifurcation, there was slight resistance, but nothing that would spark concern.The eluvia was advanced into the distal superficial femoral artery (sfa) and placement of the deployment zone was determined; the tri-axial system was held straight without any slack in the system.The physician started to use the thumbwheel and deployed the eluvia.The martini glass shape of the stent was out and secure.The thumbwheel was used to deploy the rest of the stent and the blue plunger was used to deploy the remainder of the 150 mm stent without any resistance.It was noticed that the proximal end of the stent was not visible.At first, it was thought to be because of the severity of the calcium that the stent couldn't be seen very well.Magnification of the stent revealed that about 20 mm of the stent was deployed and the rest of the stent was missing.There was no proximal end because the stent had fractured and completely separated.A few minutes were spent looking for the rest of the stent and it was thought to be in the catheter of the tri-axial system of the eluvia.The physician started to pin and pull the eluvia system over the wire to take it out.The eluvia catheter got stuck on the aortic bifurcation in the sheath.Upon removal, the eluvia only had the outer blue covering of the tri-axial system.It was missing the silver and brown layers.The physician pulled the sheath out, and the sliver layer was found inside the sheath and the brown layer was completely stuck to the wire.The remainder of the missing stent was lodged in the sheath.It was determined that all the pieces of the tri-axial system and stent were accounted for.A balloon was advanced down to the partial stent and inflated to secure it to the vessel wall.The physician lined the next eluvia to partially cover the stent that had fractured and proceeded to use two more eluvia stents and an innova to finish the case.No harm to the patient and the sfa was completely open on the final run.

• 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: 19073931
• MDR Text Key: 339776827
• Report Number: 2124215-2024-21078
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• 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: 04/09/2024

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 Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030582376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male