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

Model Number 24657

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that stent partial deployment occurred.The 70% pre-dilated target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery (sfa).A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected to be deployed in the index procedure in the sfa intervention.The physician was deploying the eluvia over a.014 inch non-boston scientific guidewire when approximately 2/3 of the way through deployment, the stent would not deploy any further.The blue handle on the back of the delivery system was pulled out completely, yet the stent would not fully deploy.The physician broke the handle and manually pulled on the catheters until the stent was off of the delivery system.The original stent was deployed to complete the procedure.There were no patient complications reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15438228
• MDR Text Key: 304916138
• Report Number: 2124215-2022-34795
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028546141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female