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 Problem Embolism (1829)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that a right peroneal artery embolism occurred post right superficial femoral artery (sfa) stenting.The patient was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right leg mid superficial femoral artery (sfa) extending into the distal sfa with 90% stenosis and was 190mm long with a proximal and distal reference vessel diameter of 5.00mm, and was classified as tasc ii c lesion.The target lesion was treated with placement of a 6x150mm and a 6x100mm eluvia study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, during the index procedure, post deployment of the study stents, completion angiogram of the runoff revealed some evidence of embolism in the tibioperoneal trunk, which was decided to treat with aspiration thrombectomy.An additional angiogram was performed which revealed that the embolic material had moved into the proximal portion of the peroneal artery and the posterior tibial artery was widely patent.On the same day, the embolism noted in the proximal portion of the peroneal artery was treated with aspiration thrombectomy.A completion angiogram demonstrated that there was good flow through the peroneal artery, with no evidence of embolic material within the peroneal artery.

• 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: 8433839
• MDR Text Key: 139239985
• Report Number: 2134265-2019-02596
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• 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: 0018822229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR