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

Model Number 24657

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - mid 60's.Date of event estimated using the first day of aware month.Implant date estimated using the first day of aware month.

Event Description

It was reported that the delivery system was difficult to remove.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in the extremely tortuous, highly calcified superficial femoral artery (sfa).The eluvia stent was deployed in the sfa, but the delivery system was unable to be pulled back through the non-boston scientific 6f sheath.Therefore, both devices were removed together.Both devices had accordioned due to the heavy calcium.A second stent was placed without incident.No patient complications were reported.

Event Description

It was reported that the delivery system was difficult to remove.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in the extremely tortuous, highly calcified superficial femoral artery (sfa).The eluvia stent was deployed in the sfa, but the delivery system was unable to be pulled back through the non-boston scientific 6f sheath.Therefore, both devices were removed together.Both devices had accordioned due to the heavy calcium.A second stent was placed without incident.No patient complications were reported.It was further reported that the target lesion was 70% stenosed.After implanting the stent, the delivery system and wire were removed together.The device was removed intact.The second stent was originally planned as part of this procedure.

Manufacturer Narrative

A2: age at time of event - mid 60's.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16900167
• MDR Text Key: 314888780
• Report Number: 2124215-2023-22224
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• 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,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0029333328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F ANSEL COOK SHEATH.; 6F ANSEL COOK SHEATH.