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 Problems Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 59 years old at the time of study enrollment.

Event Description

Eminent clinical study it was reported that in-stent 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 superficial femoral artery (sfa) with 100% stenosis and was 200 mm long with a proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.5 mm and was classified as tasc ii a lesion.Target lesion was treated with pre-dilatation, followed by placement of two 6 mm x 120 mm study stents.Post dilatation was performed with final stenosis of 0%.On (b)(6) 2019, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2022, 1120 days post index procedure, the subject presented for protocol scheduled 36 month follow up visit with the symptoms of some pain or cramps in calves and claudication about a distance of 200 mts.On arrival, rutherford category was 3 (severe claudication).Abi on the left was 0.87.On the same day, arterial color duplex ultrasound was performed, which revealed closed vessel at the proximal tract and occlusion of the endoprosthesis in the middle and distal tract of left sfa also left popliteal artery vessel was diffusely atheromatous and were readapted from collateral circulation to the proximal tract where velocimetric profiles reduced in terms of width and monophasic shape.The subject was diagnosed with obliterating arterial disease of the lower limbs and occlusion of the endoprosthesis in the left superior femoral artery.The event was treated medically.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15941020
• MDR Text Key: 305073167
• Report Number: 2124215-2022-50504
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023144488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White