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); Thrombosis/Thrombus (4440)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Clinical trial (b)(6).It was reported that in-stent thrombosis occurred.The subject was enrolled in the (b)(6) clinical study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was 70% stenosis located in the right distal superficial femoral artery (sfa), 60 mm long with a proximal reference vessel diameter of 8 mm and distal reference vessel diameter of 6 mm and was classified as a tasc ii a lesion.The target lesion was treated with direct placement of a 6 mm x 60 mm eluvia drug-eluting vascular stent system.Following post-dilation, residual stenosis was 18%.The subject was discharged with antiplatelet therapy the next day.On (b)(6) 2021, 980 days post-index procedure, the subject presented due to recently worsening lower limb pain without trophic disorder and a complete thrombosis noted in the right sfa stent.Doppler ultrasound examination of the lower extremity arterial system revealed the stent completely thrombosed with a resumption of patency in the region of the proximal popliteal artery with subsequent demodulated and dampened flow in the three arteries of the leg, which were still perfectly patent.The common femoral artery was nicely patent, however, a large posterior calcified plaque, without anything to suggest significant stenosis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12481288
• MDR Text Key: 271690996
• Report Number: 2134265-2021-11623
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021887981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR