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

Model Number 24653

Device Problem Difficult to Insert (1316)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was discontinued due to severe pain and excessive bleeding.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure in the superficial femoral artery.The 100% stenosed target lesion was located in severely calcified and moderately tortuous anatomy.During the procedure, the eluvia device was unable to cross the side hole of the non-boston scientific guide catheter.Therefore, the catheter was pushed harder; however, the procedure was discontinued as the patient experienced severe pain at the approach site and excessive bleeding was observed.No further patient complications were reported.

Event Description

It was reported that the procedure was discontinued due to severe pain and excessive bleeding.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure in the superficial femoral artery.The 100% stenosed target lesion was located in severely calcified and moderately tortuous anatomy.During the procedure, the eluvia device was unable to cross the side hole of the non-boston scientific guide catheter.Therefore, the catheter was pushed harder; however, the procedure was discontinued as the patient experienced severe pain at the approach site and excessive bleeding was observed.No further patient complications were reported.It was further reported that the bleeding and pain was not related to the eluvia device.The pain was due to the bleeding, so no treatment was performed other than a little more anesthesia was added.The bleeding was stopped by manual compression for a long time.

• 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: 15763342
• MDR Text Key: 307311550
• Report Number: 2124215-2022-46346
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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: 05/15/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027498495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• 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: RIKISHI CATHETER; RIKISHI CATHETER
• Patient Sex: Female