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 No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160)

Event Date 04/25/2019

Event Type  Injury  

Event Description

It was reported that a dissection occurred.On (b)(6) 2019 thrombectomy was performed in the distal superficial femoral artery (sfa) to remove thrombi in a study stent and stenosis in the mid sfa.There was 100 % thrombotic stenosis within the previously placed study stent and 90% stenosis in mid sfa.Post this, sfa extending to the popliteal artery was treated with balloon angioplasty and the deployment of a 6 x 120 mm non-study eluvia stent.This resulted in a dissection which was further treated with the deployment of another 6 x 120 mm non-study eluvia stent in the sfa.Following post-dilatation, the residual stenosis was noted to be 25%.Follow up core-lab angiography dated (b)(6) 2019 noted thrombus of grade 0 and absence of aneurysm.However, core-lab noted the presence of isr pattern 4.Additionally, the stenosis noted in the left tibial artery was treated with ballooning with 25% residual stenosis.On (b)(6) 2019 abi was done again which measured 0.87 and 0.84 on the right side and left sides respectively.On (b)(6) 2019, the event was considered resolved and the patient was discharged on the same day.

Manufacturer Narrative

Device is a combination product.Correction based on additional information that was received.H6 patient code dissection 3160 was corrected to no known impact or consequence to patient 2692.

Event Description

It was reported that a dissection occurred.On (b)(6) 2019 thrombectomy was performed in the distal superficial femoral artery (sfa) to remove thrombi in a study stent and stenosis in the mid sfa.There was 100 % thrombotic stenosis within the previously placed study stent and 90% stenosis in mid sfa.Post this, sfa extending to the popliteal artery was treated with balloon angioplasty and the deployment of a 6x120mm non-study eluvia stent.This resulted in a dissection which was further treated with the deployment of another 6x120mm non-study eluvia stent in the sfa.Following post-dilatation, the residual stenosis was noted to be 25%.Follow up core-lab angiography dated (b)(6) 2019 noted thrombus of grade 0 and absence of aneurysm.However, core-lab noted the presence of isr pattern 4.Additionally, the stenosis noted in the left tibial artery was treated with ballooning with 25% residual stenosis.On (b)(6) 2019 abi was done again which measured 0.87 and 0.84 on the right side and left sides respectively.On (b)(6) 2019, the event was considered resolved and the patient was discharged on the same day.Additional information further reported that the dissection did not occur due to the placement of the eluvia stent.The two eluvia stents were placed after the dissection occurred.

• 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
• MDR Report Key: 9088300
• MDR Text Key: 161055315
• Report Number: 2134265-2019-11387
• 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: 10/17/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR