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

Model Number 24657

Device Problems Entrapment of Device (1212); Difficult or Delayed Activation (2577); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Event Description

It was reported that the stent elongated during deployment and the device became stuck on the wire.The target lesion was located in the mildly tortuous and mildly calcified lower extremity.Contralateral approach was performed.The lesion was 50 percent stenosed after atherectomy.During deployment to place the 7 x 120, 130cm eluvia drug-eluting vascular stent system, the thumbwheel and pull grip were used to deploy the stent.The stent became slightly elongated approximately 3cm.The delivery system locked on the thruway guidewire.The delivery system and the guidewire were removed together as one from the patient.There were no patient complications and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr: the device was returned with a.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is separated.The proximal section is missing, and the distal section is still inside the handle.The handle was open so the inside could be inspected.The proximal inner prolapsed.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 partial deployment occurred and the device became elongated and stuck on the guidewire.The target lesion was located in the mildly tortuous and mildly calcified lower extremity.Contralateral approach was performed.The lesion was 50 percent stenosed after atherectomy.During deployment to place the 7x120, 130cm eluvia drug-eluting vascular stent system, the stent became slightly elongated approximately 3cm.The delivery system locked on the thruway guidewire.The delivery system and the guidewire were removed together as one from the patient.There were no patient complications and the patient's status was fine.

• 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: 10163189
• MDR Text Key: 195426695
• Report Number: 2134265-2020-08067
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0023144770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Date Manufacturer Received: 07/09/2020
• Patient Sequence Number: 1
• Treatment: GUIDE SHEATH: TERUMO DESTINATION SHEATH 7FR; GUIDE SHEATH: TERUMO DESTINATION SHEATH 7FR; GUIDEWIRE: THRUWAY; GUIDEWIRE: THRUWAY; GUIDE SHEATH: TERUMO DESTINATION SHEATH 7FR; GUIDEWIRE: THRUWAY