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

Model Number 24657

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated as event date was not reported.

Event Description

It was reported that partial stent deployment occurred.Two 6x120x130 eluvia drug-eluting vascular stent systems were selected for a procedure in the popliteal artery, distal and mid superficial femoral artery (sfa).During the procedure, the stent was advanced contralaterally over a 0.035 bentson guidewire inside a 6fr non-boston scientific sheath to the target lesion.The lesion was pre dilated by a 5 mm mustang balloon.The first 6x120x130 eluvia stent deployed successfully in the popliteal artery.The second stent had difficulty to separate from delivery system which caused the stent to elongate.Then, the physician manually pulled the delivery system.The patient was taken to operating room and the stent was successfully removed by surgical intervention.The vascular surgeon determined that the stent was fully deployed but it was not placed properly.There were no patient complications and the patient's was doing great post-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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10791156
• MDR Text Key: 214747476
• Report Number: 2134265-2020-15262
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0024324997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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
• Treatment: TERUMO - 6F DESTINATION SHEATH; UNKNOWN - 0.035 BENTSON GUIDEWIRE
• Patient Outcome(s): Required Intervention