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

Device Problems Fracture (1260); Device-Device Incompatibility (2919)

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

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported that the stent fractured.A 3mm x 40mm x 146cm coyote es balloon catheter was selected for use in an endovascular therapy procedure.The 99% stenosed, moderately calcified, and severely tortuous lesion was located below the knee.The coyote balloon was inflated in the lesion, and when attempting to dilate and withdraw the balloon, resistance was felt while removing it.When it was removed, the balloon end was separated.It was noted that this eluvia drug-eluting vascular stent system was implanted approximately two to three years ago in the popliteal vessel and had fractured due to the joint site.When the coyote balloon was used, it was thought to have become stuck on the fractured stent.Another balloon was inflated distal to the fragment, and the fragment was able to be removed withdrawing it to the guide catheter.The procedure was completed with a non-boston scientific device and plain old balloon angioplasty.There was no patient injury.

• Brand Name: ELUVIATM 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17756937
• MDR Text Key: 323519583
• Report Number: 2124215-2023-49373
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention