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

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/25/2022

Event Type  Injury  

Event Description

It was reported that in-stent thrombotic occlusion occurred.The target lesion was 95% stenosed with mild tortuosity and mild calcification and located in the left superficial femoral artery (sfa).On (b)(6)2021, a ranger drug-coated balloon was used in the left distal sfa.A non-bsc sent was used in the proximal sfa.On (b)(6)2022, an eluvia drug-coated stent was placed in the left sfa and popliteal artery.A non-bsc drug-coated balloon was used for post-dilation.On (b)(6) 2022, thrombotic occlusion was observed between the non-bsc stent and the eluvia stent in the sfa.On (b)(6) 2022, the target limb was amputated.On (b)(6) 2022, the patient died.The cause of was multiple cerebral infarctions, unrelated to amputation of the target limb.Per the physician assessment, the patient death was not to lower extremity treatments or devices such as eluvia and ranger.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17301927
• MDR Text Key: 318924308
• Report Number: 2124215-2023-35956
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• 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
• Patient Age: 96 YR
• Patient Sex: Female