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

Model Number 24653

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.Three eluvia eu, 6x120, 130 cm stents were selected for use in the superficial femoral artery (sfa) for the endovascular therapy procedure to treat the patient's pulmonary artery disease.The target lesion was reported to be 100% stenosed with moderate tortuosity and severe calcification.The sfa was accessed contralaterally and was predilated prior to stent placement.The first eluvia delivery system was advanced over the non-bsc guidewire to the target lesion.There was resistance noted during deployment, and the last few centimeters of the stent did not deploy.The entire system was pulled, and the remainder of the stent was successfully deployed.It was noted that the shaft of the catheter appeared stretched as a result of the deployment difficulties.It was unknown whether the stent was stretched.The same series of issues occurred with the placement of the additional two eluvia eu, 6x120, 130 cm stents.All three stents were reported to be fully expanded and had deployed to the expected length.There were no adverse consequences reported for the patient.

• 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: 16378280
• MDR Text Key: 309560726
• Report Number: 2124215-2023-06370
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028059665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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: ELUVIA EU, 6X120, 130 CM; ELUVIA EU, 6X120, 130 CM