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 Reocclusion (1985)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that in-stent restenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the (b)(6) clinical trial.The target lesion, located in the right mid and distal superficial femoral artery (sfa), had a 6 mm reference vessel diameter proximally and distally.The lesion had a total length of 100 mm.The target lesion was 100% occluded and was crossed through the true lumen.Pre-dilatation was performed using one balloon.Afterwards, two eluvia stents were successfully implanted (6 x 120 mm and 6 x 40 mm).Post-dilatation was performed using one balloon.Residual stenosis was 10%.There was no thrombus seen at the end of the procedure.On (b)(6) 2019, in-stent restenosis of the target lesion was observed without clinical symptoms.No action or treatment was performed.The event is ongoing.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8993637
• MDR Text Key: 157457653
• Report Number: 2134265-2019-10894
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019735465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR