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 Thrombosis (2100)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that acute thrombus occlusion occurred.Two 6x120x130 and a 7x80x130 eluvia self expanding drug eluting stents were selected for a chronic total occlusion (cto) procedure in the mildly tortuous superficial femoral artery (sfa).An antegrade and popliteal artery bidirectional approach was used to access the lesion.The procedure was successful and three devices were placed via the pull through method.Manual pressure was applied to the femoral with immobilization for six hours.The physician felt that the pulse was weak.Once the hemostatic device was removed the following day, the physician checked the pulse by palpation and did not feel the pulse and diagnosed acute thrombosis.The eluvia stent was aspirated and then a non-bsc stent was placed inside the eluvia stent.After the additional intervention, the patient had improved blood flow and no additional complications were reported.The physician consulted a colleague who felt that the thrombosis was cause by pressure on the puncture site, though the thrombogenicity unique to drug eluting stents (des) may have influenced.

• 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: 9555276
• MDR Text Key: 173971027
• Report Number: 2134265-2020-00012
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023576861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention