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 07/20/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient was (b)(6) at the time of enrollment.Initial reporter address 1: (b)(6).

Event Description

Eminent clinical trial: it was reported that thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in left mid to distal superficial femoral artery (sfa) with 90% stenosis and was 84mm long with a proximal reference vessel diameter of 4.25mm and distal reference vessel diameter of 4.59mm and was classified as tasc ii a lesion.Target lesion was treated with pre-dilatation followed by placement of a 6mm x 100mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2021, the subject presented to the protocol specified 36-month follow-up visit with the symptoms of slight pain in the left leg and experienced moderate difficulty in walking and moderate problems noted while doing daily activities.On arrival, rutherford category was 2 (moderate claudication).Abi on the left was 0.78, per source.Per source, duplex ultrasound scan performed on the same day revealed a long stretch occlusion from the origin of left sfa to the distal sfa was noted.The implanted stent in distal sfa was also occluded up to the distal end.Additionally, refilling with pathological monophasic flow pulse curve with reduced velocities of up to max 15 cm/s was detected downstream from the distal part of the stent.A pathological refilling curve was also detected in popliteal artery with peak velocities up to 20 cm/s.Thus, the above-mentioned diagnosis confirmed that the target lesion was occluded.No action was taken to treat this event.

• 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: 12305364
• MDR Text Key: 265972614
• Report Number: 2134265-2021-10088
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P180011
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020786304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1