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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed and became stretched.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 50% stenosed, moderately tortuous, and moderately calcified lesion was located in the superficial femoral artery (sfa).A crossover approach was performed for the procedure, and after crossing the wire, plain old balloon angioplasty was performed to dilate the sfa lesion which involved the entire length of the sfa from the sfa bifurcation to the distal sfa.After implanting two eluvia stents distally, an attempt was made to use this 7x150 eluvia stent in the proximal sfa.The deployment was attempted by using the thumbwheel and pull grip; however, it was only partially deployed with approximately 4cm remaining.Then the non-boston scientific guidewire used with this stent became stuck and could not be deployed despite pulling the handle.Therefore, both the guidewire and stent system were pulled toward the proximal side and the stent was then deployed.The stent became stretched at that time and the proximal edge had reached the common femoral artery (cfa).The stent was implanted inside the body, and although the stent had stretched up to the cfa, the implantation position was within an acceptable range.Post-dilatation was then performed with a balloon, there were no issues observed with the flow, and the procedure was completed.There was no patient injury.

Event Description

It was reported that the stent partially deployed and became stretched.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 50% stenosed, moderately tortuous, and moderately calcified lesion was located in the superficial femoral artery (sfa).A crossover approach was performed for the procedure, and after crossing the wire, plain old balloon angioplasty was performed to dilate the sfa lesion which involved the entire length of the sfa from the sfa bifurcation to the distal sfa.After implanting two eluvia stents distally, an attempt was made to use this 7x150 eluvia stent in the proximal sfa.The deployment was attempted by using the thumbwheel and pull grip; however, it was only partially deployed with approximately 4cm remaining.Then the non-boston scientific guidewire used with this stent became stuck and could not be deployed despite pulling the handle.Therefore, both the guidewire and stent system were pulled toward the proximal side and the stent was then deployed.The stent became stretched at that time and the proximal edge had reached the common femoral artery (cfa).The stent was implanted inside the body, and although the stent had stretched up to the cfa, the implantation position was within an acceptable range.Post-dilatation was then performed with a balloon, there were no issues observed with the flow, and the procedure was completed.There was no patient injury.

Event Description

It was reported that the stent partially deployed and became stretched.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 50% stenosed, moderately tortuous, and moderately calcified lesion was located in the superficial femoral artery (sfa).A crossover approach was performed for the procedure, and after crossing the wire, plain old balloon angioplasty was performed to dilate the sfa lesion which involved the entire length of the sfa from the sfa bifurcation to the distal sfa.After implanting two eluvia stents distally, an attempt was made to use this 7x150 eluvia stent in the proximal sfa.The deployment was attempted by using the thumbwheel and pull grip; however, it was only partially deployed with approximately 4cm remaining.Then the non-boston scientific guidewire used with this stent became stuck and could not be deployed despite pulling the handle.Therefore, both the guidewire and stent system were pulled toward the proximal side and the stent was then deployed.The stent became stretched at that time and the proximal edge had reached the common femoral artery (cfa).The stent was implanted inside the body, and although the stent had stretched up to the cfa, the implantation position was within an acceptable range.Post-dilatation was then performed with a balloon, there were no issues observed with the flow, and the procedure was completed.There was no patient injury.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia self-expanding stent system was returned with a flimsy 0.035in hydrophilic guidewire stuck inside.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no damages.The handle was x-ray, and the proximal inner was prolapsed.The stent appeared to have been deployed and was not returned for analysis.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the reported deploy issue, froze on wire, 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: 18730940
• MDR Text Key: 336632902
• Report Number: 2124215-2024-09595
• 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,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0032092996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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