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

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

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event - event date was not reported and approximated (b)(6) 2022.

Event Description

Literature review indicated the stent was occluded and treated with catheter thrombolytic therapy.It was reported that this eluvia drug-eluting vascular stent placed in the superficial femoral artery had an acute thrombotic total occlusion.The case indicated there was successful treatment of the occlusion using catheter thrombolytic therapy.No further detail were known or able to be obtained.

Manufacturer Narrative

B3: date of event - event date was not reported and approximated 01march, 2022.

Event Description

Literature review indicated the stent was occluded and treated with catheter thrombolytic therapy.It was reported that this eluvia drug-eluting vascular stent placed in the superficial femoral artery had an acute thrombotic total occlusion.The case indicated there was successful treatment of the occlusion using catheter thrombolytic therapy.No further detail were known or able to be obtained.Additional information clarified that after the guidewire was placed along with intravascular ultrasound, pre-dilation was performed using 5.0mm balloon angioplasty.It was reported that there was a dissection of the chronic total occlusion site, and two eluvia 6.0mm x 120mm were placed to treat the area.Post-treatment, the claudication had disappeared and the abi was improved.However, two days later the patient was readmitted to the hospital due to reoccurrence of resting pain of the left leg, and angiography revealed a stent occlusion of the left sfa.Intravascular ultrasound revealed a massive thrombus in the entire stented area.Balloon angioplasty along with catheter-directed thrombolytic therapy using urokinase 120,000 units/day and heparin 150,000 units/day for three days was able to successfully dissolve the thrombus.The pain was noted as resolved, and no further complications occurred during hospitalization.

• Brand Name: ELUVIATM 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14012460
• MDR Text Key: 288579693
• Report Number: 2134265-2022-03709
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female