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 Occlusion (1984)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: (b)(6).Device is combination product.

Event Description

(b)(6) study.It was reported that stent occlusion occurred.The patient underwent treatment with three eluvia study stents on (b)(6) 2019.The target lesion was located in the left ostial, proximal, middle and distal superficial femoral artery (sfa).It had a 5mm reference vessel diameter, proximally and distally, 250mm in length and 100% stenosis.Pre-dilation was performed using one balloon and three eluvia stents were implanted ( two 6x120mm stents, and a 6x100mm stent).Post-dilation was performed using one balloon and residual stenosis was 0%.On (b)(6) 2019, the subject experienced an in-stent occlusion of all three study stents of the left sfa measured occlusion was over 30cm.The subject was hospitalized and thrombolysis with percutaneous transluminal angioplasty (pta) of the left sfa was performed.The event was reported as serious and ongoing.

Event Description

Regal study.It was reported that stent occlusion occurred.The patient underwent treatment with three eluvia study stents on (b)(6) 2019.The target lesion was located in the left ostial, proximal, middle and distal superficial femoral artery (sfa).It had a 5mm reference vessel diameter, proximally and distally, 250mm in length and 100% stenosis.Pre-dilation was performed using one balloon and three eluvia stents were implanted ( two 6x120mm stents, and a 6x100mm stent).Post-dilation was performed using one balloon and residual stenosis was 0%.On (b)(6) 2019, the subject experienced an in-stent occlusion of all three study stents of the left sfa measured occlusion was over 30cm.The subject was hospitalized and thrombolysis with percutaneous transluminal angioplasty (pta) of the left sfa was performed.The event was reported as serious and ongoing.It was further reported that the event was resolved as of (b)(6) 2019.

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: (b)(6).Device is combination product.

• 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
• MDR Report Key: 9273013
• MDR Text Key: 165068400
• Report Number: 2134265-2019-13302
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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
• Device Lot Number: 0023305720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: ELUVIA 6X100; STENT: ELUVIA 6X100; STENT: ELUVIA 6X120; STENT: ELUVIA 6X120
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR