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

Model Number 24653

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.The 99% stenosed target lesion was located in the severely calcified and mildly tortuous superficial femoral artery (sfa).A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.Pre-dilatation was performed and the stent was advanced contralaterally over a non-bsc 0.035" guidewire.During the procedure, the stent was deployed using the thumbwheel with strong force.However, about 4cm of the stent remained inside the middle sheath.The middle sheath felt stuck.The entire length of the stent was deployed by removing the system.The procedure was completed with this device.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: 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 inner liner 10.8cm from the tip and a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.Per product specification, a 0.035" test guidewire was advance into the device and was able to pass through.The handle was x-ray with the test guidewire still inside and no abnormalities were found.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed.The 99% stenosed target lesion was located in the severely calcified and mildly tortuous superficial femoral artery (sfa).A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.Pre-dilatation was performed and the stent was advanced contralaterally over a non-bsc 0.035" guidewire.During the procedure, the stent was deployed using the thumbwheel with strong force.However, about 4cm of the stent remained inside the middle sheath.The middle sheath felt stuck.The entire length of the stent was deployed by removing the system.The procedure was completed with this device.There were no patient complications.It was further reported that the stenosed lesion was recoiled (became undilated again) after it was pre-dilatated.No stent elongation occurred.

Manufacturer Narrative

Device evaluated by mfr: 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 inner liner 10.8cm from the tip and a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.Per product specification, a 0.035" test guidewire was advance into the device and was able to pass through.The handle was x-ray with the test guidewire still inside and no abnormalities were found.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed.The 99% stenosed target lesion was located in the severely calcified and mildly tortuous superficial femoral artery (sfa).A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.Pre-dilatation was performed and the stent was advanced contralaterally over a non-bsc 0.035" guidewire.During the procedure, the stent was deployed using the thumbwheel with strong force.However, about 4cm of the stent remained inside the middle sheath.The middle sheath felt stuck.The entire length of the stent was deployed by removing the system.The procedure was completed with this device.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
• MDR Report Key: 9284511
• MDR Text Key: 168298126
• Report Number: 2134265-2019-13313
• 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,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023682850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DESTINATION 6F, 45CM INTRODUCER SHEATH.; DESTINATION 6F, 45CM INTRODUCER SHEATH.; DESTINATION 6F, 45CM INTRODUCER SHEATH.; RADIFOCUS STIFF TYPE, 0.035INCH, 300CM GUIDEWIRE.; RADIFOCUS STIFF TYPE, 0.035INCH, 300CM GUIDEWIRE.; RADIFOCUS STIFF TYPE, 0.035INCH, 300CM GUIDEWIRE.