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 (2100)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

This is a combination device.Age at time of event: subject was (b)(6) years old at time of enrollment.

Event Description

(b)(6) clinical study.It was reported that occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid to distal superficial femoral artery (sfa) with 100% stenosis and was 180mm long with a proximal reference vessel diameter of 6mm and distal reference vessel diameter of 6mm and was classified as tasc ii c lesion.Target lesion was treated with pre-dilation following by placement of two 6 mm x 100 mm study stents in the target lesion.Following post dilation, the residual stenosis was 30%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, 91 days post index procedure, the subject presented with the symptoms of acute deterioration while walking up to 20 m distance from past 2 days down.The onset date of the event is entered as (b)(6) 2019.On (b)(6) 2019, duplex revealed in-stent occlusion of the stent in the middle third flow of left sfa.Over the further length, long segment stent occlusion was also noted.The subject was recommended to undergo surgical intervention on a later date to treat this event.On (b)(6) 2019, the subject was hospitalized for further evaluation and treatment.Doppler index was 0.88 on the right and 0.53 on the left.On (b)(6) 2019, peripheral artery occlusive disease (paod) clinical stage was iib associated with acute occlusion of two drug eluting stents in the left-sfa.On the same day, rotarex thrombectomy with 6 french device was performed in the left sfa by insertion of a lysis catheter.On (b)(6) 2019, 98 days post index procedure, atherectomy of the proximal sfa and the popliteal in the pi segment using hawkone 7 french atherectomy catheter was performed which resulted in plaque reduction up to 30%.Following this, drug coated balloon angioplasty of the proximal sfa using 6 x 100 mm stellarex and the popliteal using 5 x 80 mm stellarex was also performed to treat this event.Of note, site has been queried to confirm if the event would be reported as a cec event of tvr as well.Response awaited.On (b)(6) 2019, the event was considered resolved and the subject was discharge on the same day in a good general state.

Event Description

Eminent clinical study.It was reported that occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid to distal superficial femoral artery (sfa) with 100% stenosis and was 180mm long with a proximal reference vessel diameter of 6mm and distal reference vessel diameter of 6mm and was classified as tasc ii c lesion.Target lesion was treated with pre-dilation following by placement of two 6 mm x 100 mm study stents in the target lesion.Following post dilation, the residual stenosis was 30%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, 91 days post index procedure, the subject presented with the symptoms of acute deterioration while walking up to 20 m distance from past 2 days down.The onset date of the event is entered as on (b)(6) 2019.On (b)(6) 2019, duplex revealed in-stent occlusion of the stent in the middle third flow of left sfa.Over the further length, long segment stent occlusion was also noted.The subject was recommended to undergo surgical intervention on a later date to treat this event.On (b)(6) 2019, the subject was hospitalized for further evaluation and treatment.Doppler index was 0.88 on the right and 0.53 on the left.On (b)(6) 2019, peripheral artery occlusive disease (paod) clinical stage was iib associated with acute occlusion of two drug eluting stents in the left-sfa.On the same day, rotarex thrombectomy with 6 french device was performed in the left sfa by insertion of a lysis catheter.On (b)(6) 2019, 98 days post index procedure, atherectomy of the proximal sfa and the popliteal in the pi segment using hawkone 7 french atherectomy catheter was performed which resulted in plaque reduction up to 30%.Following this, drug coated balloon angioplasty of the proximal sfa using 6 x 100 mm stellarex and the popliteal using 5 x 80 mm stellarex was also performed to treat this event.Of note, site has been queried to confirm if the event would be reported as a cec event of tvr as well.Response awaited.On (b)(6) 2019, the event was considered resolved and the subject was discharge on the same day in a good general state.It was further reported that checkup angiography showed residual thrombi and therefore a lysis catheter was inserted after the thrombectomy on (b)(6) 2019.Intra-arterial administration of actilyse was performed.The catheter was fixed here.The patient was transferred to the intensive care ward for further monitoring.The checkup angiography showed good result after the procedure on (b)(6) 2019.As there was good flow, the sheath and catheter material were removed.The patient had a strong posterior pulse.

Manufacturer Narrative

A2: age at time of event: subject was 78 years old at time of enrollment.

• 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: 9937782
• MDR Text Key: 187890069
• Report Number: 2134265-2020-04663
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022992323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention