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 09/07/2023

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed and stretched.A 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in the right lower extremity.The patient was being treated for peripheral artery disease (pad).This was a contralateral approach with access through the left femoral artery using a non-boston scientific 7f x 65 sheath.The 100% stenosed target lesion was a chronic total occlusion (cto) with severe calcification and located in the moderately tortuous superficial femoral artery (sfa).The entire sfa was ballooned with non-boston scientific 5mm and 6mm diameter balloons.Additionally, using a non-boston scientific device, atherectomy was performed due to eccentric lesions.Non-boston scientific shockwave therapy was also performed throughout the sfa.A 7x150 eluvia was then placed in the distal to mid sfa over a 0.14 wire.A second 7x150 eluvia was placed in the mid to proximal sfa.During this deployment, the thumbwheel was used to place the stent for the first 30mm while letting the stent expand for a few seconds to adhere to the vessel wall.The blue handle was then pulled to deploy the rest of the stent, which is how this physician deploys all of their stents.The blue handle became jammed when approximately 1/2 to 3.4 of the stent was deployed.The physician tried using the thumbwheel again, but it was also jammed.More force was applied on the blue handle with little deployment.Eventually with force, the blue handle was pulled all the way back with the remaining portion of the stent still not deployed.The main white body of the stent deployment system was pried open.Inside it was observed that the two inner catheters of the deployment system were twisted up.The catheters were attempted to be straightened, but the mangled catheters were cut.A pin and pull method was used to try and expand the stent the rest of the way with extreme resistance.Eventually the stent was able to be deployed completely out of the catheter, but it was also stretched in the process to approximately a 250mm length.The stents were post dilated, and repeat angiograph showed no restrictive flow.No patient complications were reported, and the patient fully recovered.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014-inch guidewire stuck in the device.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the handle was open.There was multiple buckling to the middle sheath.The outer sheath was buckled at the nosecone.The proximal inner was prolapsed.The middle sheath was separated from the retainer.The proximal inner liner was separated 15cm from the proximal end.The clip that attaches the proximal inner liner to the handle was missing.The pull rack was damaged, and the thumbwheel teeth were damaged.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue and stent deformation.

• 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: 17856973
• MDR Text Key: 324780016
• Report Number: 2124215-2023-53976
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030402840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male