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)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that this device partially deployed.This 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 100% stenosed, moderately tortuous, and mildly calcified lesion was located in the superficial femoral artery.During the procedure, a crossover approach was used, and plain old balloon angioplasty (poba) was performed for the lesion using a non-boston scientific balloon.Then an eluvia stent was placed from the peripheral side along with a second eluvia stent to cover the lesion more fully.During deployment of this third eluvia stent, the thumbwheel became idle with one to two centimeters of the stent left to deploy.Therefore, the stent was fully deployed by pulling the entire handle.Then the guidewire and shaft became stuck and had to be removed together.There was no patient injury.

Event Description

It was reported that this device partially deployed.This 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 100% stenosed, moderately tortuous, and mildly calcified lesion was located in the superficial femoral artery.During the procedure, a crossover approach was used, and plain old balloon angioplasty (poba) was performed for the lesion using a non-boston scientific balloon.Then an eluvia stent was placed from the peripheral side along with a second eluvia stent to cover the lesion more fully.During deployment of this third eluvia stent, the thumb wheel became idle with one to two centimeters of the stent left to deploy.Therefore, the stent was fully deployed by pulling the entire handle.Then the guidewire and shaft became stuck and had to be removed together.There was no patient injury.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia drug-eluting vascular stent system was inspected for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic and x-ray examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a kink on the device that may have contributed to the reported event.

• 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: 17258874
• MDR Text Key: 318649799
• Report Number: 2124215-2023-35071
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029744877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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