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

Model Number	H74939294701210
Medical Device Problem Codes	Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partially deployed, and upon pulling the system the stent fully deployed albeit stretched.The target lesion was in the superficial femoral artery; 85% stenosed with mild tortuosity and moderate calcification.Pre-dilatation was performed using coyote balloon and then treated with shockwave treatment.After shockwave treatment, an angiogram was obtained and revealed that approximately 50% stenosis remained and that a stent was needed.The 7mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected with no apparent issues upon prepping and insertion.The stent advanced to target area with no issues or resistance; however, upon deployment of the stent about 1/3 of the stent was deployed and the deployment wheel started to make a different audible noise and then it completely locked up.With the stent not fully deployed, the physician tried several measures to get the rest deployed.The thumb wheel was frozen and would not turn either direction and the deployment handle was also frozen and would not move.The physician also attempted to slowly walk back the stent catheter to see if the stent would pull out of the catheter, but was unsuccessful.The physician cut the stent catheter and wire just in front of the white handle, and with the handle removed were able to successfully deploy the rest of the stent.The remainder of the catheter was successfully removed, and the stent was post-dilated with a 7x100mm mustang balloon.The final angiogram revealed successful stent deployment with proper wall apposition and slightly elongated/stretched approximately 2-3 centimeters.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: this eluvia drug-eluting vascular stent system was returned for analysis with a 0.014-inch guidewire stuck in the device; however, the stent was implanted and did not return for analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pull rack is separated 10.5cm from the knob.The outer sheath, middle sheath, proximal inner, and inner liner are separated at the nosecone.There is multiple areas of buckling along the outer sheath and multiple kinks along the whole device.Microscopic examination revealed no additional damages.X-ray of the device handle found that the proximal inner is prolapsed.Product analysis confirmed that proximal inner is prolapsed which would have contributed to the deployment issue, stent deformation, and stuck on wire.
Event or Problem Description
It was reported that the stent was partially deployed, and upon pulling the system the stent fully deployed albeit stretched.The target lesion was in the superficial femoral artery; 85% stenosed with mild tortuosity and moderate calcification.Pre-dilatation was performed using coyote balloon and then treated with shockwave treatment.After shockwave treatment, an angiogram was obtained and revealed that approximately 50% stenosis remained and that a stent was needed.The 7mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected with no apparent issues upon prepping and insertion.The stent advanced to target area with no issues or resistance; however, upon deployment of the stent about 1/3 of the stent was deployed and the deployment wheel started to make a different audible noise and then it completely locked up.With the stent not fully deployed, the physician tried several measures to get the rest deployed.The thumb wheel was frozen and would not turn either direction and the deployment handle was also frozen and would not move.The physician also attempted to slowly walk back the stent catheter to see if the stent would pull out of the catheter, but was unsuccessful.The physician cut the stent catheter and wire just in front of the white handle, and with the handle removed were able to successfully deploy the rest of the stent.The remainder of the catheter was successfully removed, and the stent was post-dilated with a 7x100mm mustang balloon.The final angiogram revealed successful stent deployment with proper wall apposition and slightly elongated/stretched approximately 2-3 centimeters.No patient complications were reported.

• Brand Name: ELUVIA?
• 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: 21480088
• Report Number: 2124215-2025-11880
• Device Sequence Number: 8435865
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: (01)08714729876731(17)260621(10)34404212
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/02/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2026
• Device Model Number: H74939294701210
• Device Catalogue Number: H74939294701210
• Device Lot Number: 0034404212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 014 ASAHI CONFIANZA; 014 ASAHI CONFIANZA; COYOTE BALLOON; COYOTE BALLOON; MUSTANG BALLOON; MUSTANG BALLOON; SHOCKWAVE TREATMENT; SHOCKWAVE TREATMENT
• Patient Sex: Unknown