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

Model Number 24653

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  Injury  

Event Description

It was reported that the stent fractured.A 6mmx120mm, 130cm eluvia drug-eluting vascular stent system was selected for an arterial stenting procedure.During the procedure, the stent fractured into two segments.One portion remained in the patient's artery and the other within the non-boston scientific 6fr sheath.An additional stent was placed.There were no further patient complications reported.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system.The proximal section of the pull rack and the distal section of the stent were not returned for analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual and microscopic examination were completed.Analysis revealed that the pull rack is separated and the distal section is inside the handle.The handle was open and the first teeth near the retainer is flattened.The pull rack measures approximately 14.4cm from the retainer to the separation.The outer sheath is separated from the nosecone.The middle sheath is separated from the retainer.The outer sheath is buckled 47.7cm from the outer sheath separation.The proximal section of the stent appears to be stuck inside the guide sheath.The stent appears to have been stretched prior to separating.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent fractured.A 6mmx120mm, 130cm eluvia drug-eluting vascular stent system was selected for an arterial stenting procedure.During the procedure, the stent fractured into two segments.One portion remained in the patient's artery and the other within the non-boston scientific 6fr sheath.An additional stent was placed.There were no further patient complications reported.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11117463
• MDR Text Key: 225091368
• Report Number: 2134265-2020-18759
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0025998318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 02/12/2021
• Patient Sequence Number: 1
• Treatment: 6F ARROW SHEATH (65 CM); 6F ARROW SHEATH (65 CM); 6F ARROW SHEATH (65 CM)
• Patient Outcome(s): Required Intervention