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

Model Number 24653

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use with a 0.014 guidewire in the moderately tortuous superficial femoral artery (sfa).A contralateral approach was used to access the lesion.A strong force was used on the thumbwheel to deploy.After 90% of the stent was deployed, it was unable to further deploy.The handle was disassembled and the shaft was removed safely.The stent deployed and the procedure was completed with this device.There were no patient complications.The physician considered the cause was that some force was applied to the inner shaft and the middle shaft could not be pulled.The inner shaft may have become bent in the system while pushing and pulling the wire, which caused deployment failure.

Manufacturer Narrative

A2: age at time of event: 18 years or older.Device eval by manufacturer: the returned product consisted of an eluvia self-expanding stent system.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, and there were multiple kinks to the proximal inner.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use with a 0.014 guidewire in the moderately tortuous superficial femoral artery (sfa).A contralateral approach was used to access the lesion.A strong force was used on the thumbwheel to deploy.After 90% of the stent was deployed, it was unable to further deploy.The handle was disassembled and the shaft was removed safely.The stent deployed and the procedure was completed with this device.There were no patient complications.The physician considered the cause was that some force was applied to the inner shaft and the middle shaft could not be pulled.The inner shaft may have become bent in the system while pushing and pulling the wire, which caused deployment failure.It was further reported that the mildly calcified target lesion was pre-dilated with a 5mm balloon.The target lesion was a chronic total occlusion, but after expansion, the residual stenosis was 80%.A contralateral approach was used in this procedure.

• 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: 10809619
• MDR Text Key: 215308533
• Report Number: 2134265-2020-15517
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024275755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1