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

Model Number 24653

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed and stretched.Vascular access was gained via contralateral approach.The 80% stenosed target lesion was located in the moderately tortuous superficial femoral artery (sfa).A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.The bending angle was moderate.A non-boston scientific guide catheter and a 014 guidewire were advanced without difficulty.Pre-dilation was performed with a coyote mr 4.0x220 without difficulty.The eluvia was advanced without difficulty.The thumbwheel was rotated, and deployment was started; however, it was stiffer than usual.The stent was gradually deployed while continuously rotating the thumbwheel.The thumbwheel stopped rotating when about half of the 120mm stent was deployed.The arrow on the pull grip was visible.The pull grip could not be pulled any further.The entire stent was slightly pulled but it could not be released.The stent stretched approximately 5cm, and the upper end of the stent extended to the upper end of the common femoral artery (cfa).The system was damaged, and the middle sheath was pulled; however, the stent could not be pulled out.The stent was able to deploy when the inner sheath was pushed proximally on the innermost.The non-boston scientific guidewire got stuck with the stent and the delivery system and the guidewire were removed together.A new non-boston scientific guidewire was passed through the stent again, and the procedure was completed with post expansion using a mustang 6.0x40 balloon.There were no patient complications.

Event Description

It was reported that the stent partially deployed and stretched.Vascular access was gained via contralateral approach.The 80% stenosed target lesion was located in the moderately severe superficial femoral artery (sfa).A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.The bending angle was moderate.A non-boston scientific guide catheter and a 014 guidewire were advanced without difficulty.Pre-dilation was performed with a coyote mr 4.0x220 without difficulty.The eluvia was advanced without difficulty.The thumbwheel was rotated, and deployment was started; however, it was stiffer than usual.The stent was gradually deployed while continuously rotating the thumbwheel.The thumbwheel stopped rotating when about half of the 120mm stent was deployed.The arrow on the pull grip was visible.The pull grip could not be pulled any further.The entire stent was slightly pulled but it could not be released.The stent stretched approximately 5cm, and the upper end of the stent extended to the upper end of the common femoral artery (cfa).The system was damaged, and the middle sheath was pulled; however, the stent could not be pulled out.The stent was able to deploy when the inner sheath was pushed proximally on the innermost.The non-boston scientific guidewire got stuck with the stent and the delivery system and the guidewire were removed together.A new non-boston scientific guidewire was passed through the stent again, and the procedure was completed with post expansion using a mustang 6.0x40 balloon.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system with a flimsy 0.035 inch hydrophilic guidewire stuck inside.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open.There are multiple locations of buckling to the proximal inner.Microscopic examination revealed no damages.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18502502
• MDR Text Key: 332770239
• Report Number: 2124215-2023-75901
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: DESTINATION; GUIDE CATHETER: DESTINATION; GUIDEWIRE: 014 RADIFOCUS; GUIDEWIRE: 014 RADIFOCUS