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

Model Number 24653

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the stent foreshortened.An ipsilateral antegrade approach was used to access the target lesion.The 100% stenosed target lesion was located in the severely calcified right superficial femoral artery (sfa) ostium to the popliteal.It was a complex lesion where balloons and guidewire had difficulty crossing.Pre-dilation was performed with a 4mm balloon.Two 6x120, 130 cm eluvia drug-eluting vascular stent systems and one 6x80, 130 cm eluvia drug-eluting vascular stent system were selected for use.The first 6x120 eluvia was desired to be placed above the knee.However, the eluvia was unable to advance to that placement location and was placed in the middle.During deployment, the last thumbwheel movement spun idly and the pull grip was used to complete deployment.The stent was shortened approximately 40mm.The shaft after deployment was difficult to remove.Pre-dilation was performed with a 5mm balloon and the second 6x120 eluvia was placed in the distal lesion beyond the first eluvia.It was planned to overlap with the distal end of the first eluvia with a margin, but the stent shortened approximately 20mm, and it had a gap.The shaft after deployment was also difficult to remove.When the 6x80 eluvia was placed, the stent shortened 10mm and it seemed that the tip of the stent was not fully expanded.No additional interventions were performed.Standard post-dilation was completed for all three stents.There were no patient complications.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10886420
• MDR Text Key: 219154728
• Report Number: 2134265-2020-16299
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0025204957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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