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 07/05/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

It was reported that stenosis at the proximal edge of the placed stent occurred.The patient underwent treatment on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the distal superficial femoral artery (sfa) of the left leg which had a 5.5mm reference vessel diameter proximally and distally, and a total length of 50mm visually estimated.The target lesion was 80% occluded and crossed through the true lumen.Pre-dilatation was performed using one balloon.Afterwards, one 6x60mm eluvia stent and one 6x40mm eluvia stent were implanted.Post-dilatation was performed using one balloon and 0% residual stenosis remained.No thrombus was seen at the end of the procedure.On (b)(6) 2019, a middle-graded stenosis of the sfa left leg at the proximal edge of the 6x40mm eluvia stent was observed.No actions were taken yet and the event was reported as 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8837029
• MDR Text Key: 152511971
• Report Number: 2134265-2019-08820
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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: 0019735467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• 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: 73 YR