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 07/12/2023

Event Type  Injury  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that the stent was partially deployed and was elongated as a result.An additional device was required to adequately treat the lesion.An eluvia eu, 6x120, 130 cm was selected for use in the percutaneous transluminal angioplasty procedure.The mildly tortuous target lesion was located in the superficial femoral artery (sfa) and was reported to have moderate calcification and 80% stenosis.Using a 0.014 non-boston scientific guidewire and a contralateral approach, the physician first deployed a non-boston scientific drug eluting stent in the p2 segment, and the first eluvia 6x120, before attempting to deploy the second eluvia.During deployment, the stent did not deploy completely, leaving approximately 10mm undeployed.The thumbwheel continued to spin freely.At this point, the physician observed that the guidewire was stuck in the catheter.The physician pulled the pull-grip, but the stent remained partially deployed.At this time, the physician disassembled the handle of the eluvia deployment system to attempt to deploy the stent, but the issue persisted.The physician cut the outer sheath and removed the handle to deploy the stent.The stent deployed but was elongated to approximately 130mm and the stent structure appeared weak on angiography.The physician elected to add an additional bare-metal stent next to the eluvia.The procedure was completed, and there were no reported patient complications.

Event Description

It was reported that the stent was partially deployed and was elongated as a result.An additional device was required to adequately treat the lesion.An eluvia eu, 6x120, 130 cm was selected for use in the percutaneous transluminal angioplasty procedure.The mildly tortuous target lesion was located in the superficial femoral artery (sfa) and was reported to have moderate calcification and 80% stenosis.Using a 0.014 non-boston scientific guidewire and a contralateral approach, the physician first deployed a non-boston scientific drug eluting stent in the p2 segment, and the first eluvia 6x120, before attempting to deploy the second eluvia.During deployment, the stent did not deploy completely, leaving approximately 10mm undeployed.The thumbwheel continued to spin freely.At this point, the physician observed that the guidewire was stuck in the catheter.The physician pulled the pull-grip, but the stent remained partially deployed.At this time, the physician disassembled the handle of the eluvia deployment system to attempt to deploy the stent, but the issue persisted.The physician cut the outer sheath and removed the handle to deploy the stent.The stent deployed but was elongated to approximately 130mm and the stent structure appeared weak on angiography.The physician elected to add an additional bare-metal stent next to the eluvia.The procedure was completed, and there were no reported patient complications.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Device analysis: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 in.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 pull rack was separated 10.6 cm.From the knob.The outer sheath was separated 1.8 cm.From the nosecone.The tip, distal end of the middle sheath, distal end of the outer sheath, distal end of proximal inner liner, and distal end of inner liner were all missing.The outer sheath was kinked at the nosecone.Microscopic examination revealed no additional damages.X-ray of the device showed that the proximal inner liner was prolapsed.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the froze on wire, 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: 17481952
• MDR Text Key: 320657609
• Report Number: 2124215-2023-41107
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0030091697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male