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

Model Number	24657
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent partially deployed and elongated.A 7x120, 130 cm eluvia self-expanding stent was selected for use in a superficial femoral artery (sfa) stenting procedure.A contralateral approach was used to access the target location in the sfa that was dissected, moderately calcified, and located in mildly tortuous anatomy.A 7x45 non-boston scientific guiding sheath, a.035x150 non-boston scientific support catheter, and.014x300 non-boston scientific guidewire were placed in the patient.The physician performed 2.0 laser atherectomy on the popliteal as well as the sfa.Afterwards, a non-boston scientific scoring balloon catheter was used to treat the sfa and popliteal residual disease.After angiography, diffuse disease was noted along with dissection, so it was decided to place an eluvia.The vessel was predilated with a 6x100 sterling balloon catheter.The physician proceeded to deploy a 7x120 eluvia.Resistance was felt during advancement.The physician noted that deployment felt 'off' from the beginning.The stent was deploying elongated and not evenly.The physician was unable to traditionally deploy the stent with the thumbwheel.High force was exerted on the thumbwheel.Approximately 80-90mm of the stent was deployed when the physician was forced to pop open the delivery system and perform a salvage deployment.The stent was successfully deployed via the salvage method; however, the stent was elongated roughly 100mm.The stent was post dilated.The blue delivery shaft was noted to be kinked inside the deployment system.The guidewire was then exchanged for a larger diameter guidewire, and an additional 7x150 eluvia was deployed, covering the elongated, improperly deployed 7x120 eluvia.The patient fully recovered.
Event or Problem Description
It was reported that the stent partially deployed and elongated.A 7x120, 130 cm eluvia self-expanding stent was selected for use in a superficial femoral artery (sfa) stenting procedure.A contralateral approach was used to access the target location in the sfa that was dissected, moderately calcified, and located in mildly tortuous anatomy.A 7x45 non-boston scientific guiding sheath, a.035x150 non-boston scientific support catheter, and.014x300 non-boston scientific guidewire were placed in the patient.The physician performed 2.0 laser atherectomy on the popliteal as well as the sfa.Afterwards, a non-boston scientific scoring balloon catheter was used to treat the sfa and popliteal residual disease.After angiography, diffuse disease was noted along with dissection, so it was decided to place an eluvia.The vessel was predilated with a 6x100 sterling balloon catheter.The physician proceeded to deploy a 7x120 eluvia.Resistance was felt during advancement.The physician noted that deployment felt 'off' from the beginning.The stent was deploying elongated and not evenly.The physician was unable to traditionally deploy the stent with the thumbwheel.High force was exerted on the thumbwheel.Approximately 80-90mm of the stent was deployed when the physician was forced to pop open the delivery system and perform a salvage deployment.The stent was successfully deployed via the salvage method; however, the stent was elongated roughly 100mm.The stent was post dilated.The blue delivery shaft was noted to be kinked inside the deployment system.The guidewire was then exchanged for a larger diameter guidewire, and an additional 7x150 eluvia was deployed, covering the elongated, improperly deployed 7x120 eluvia.The patient fully recovered.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with a 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 outer sheath.There were multiple kinks along the middle sheath and outer sheath.The proximal inner was prolapsed.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 difficulty to advance, deployment issue and stent deformation.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: 17703712
• Report Number: 2124215-2023-48728
• Device Sequence Number: 7511054
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030075537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: Black Or African American