MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Thrombosis (2100); Claudication (2550)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient was (b)(6) years old at time of enrollment on (b)(6) 2016.

Event Description

It was reported that in-stent thrombosis occurred.The patient was enrolled in the (b)(6) clinical study on (b)(6) 2016.The index procedure was performed on the same day.The target lesion was located in the left mid superficial femoral artery (sfa), extending to the distal sfa with 100% stenosis.The target lesion was 30mm long, with a proximal reference vessel diameter of 4.00mm and a distal vessel diameter of 4.00mm.The target lesion was treated with pre-dilatation and a 6x150mm eluvia stent was placed.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2017, the patient reported symptoms of calf pain.On (b)(6) 2017, the patient presented for a follow up visit with complaints of calf pain while ambulating.The patient underwent diagnostic ultrasound testing for the left leg which revealed no flow in the stented area of the sfa; reconstitution of flow distally.The claudication symptoms were revealed to be secondary to stent thrombosis.The patient was recommended to continue taking antiplatelet medication (pletal) and exercise daily.The patient was also recommended to follow up in the office in 6 weeks to check if claudication symptoms were improved before considering for re-intervention.On (b)(6) 2018, the patient returned for a 24 month follow up during which a diagnostic ultrasound study revealed the target lesion was occluded.No additional information was reported.

• Brand Name: ELUVIATM 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8092723
• MDR Text Key: 128018304
• Report Number: 2134265-2018-63028
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18822229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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