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

Model Number 24653

Device Problems Difficult to Insert (1316); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2020

Event Type  malfunction  

Event Description

It was reported that a stent premature deployment occurred.Vascular access was gained via contralateral approach.The 80% stenosed target lesion was located in the highly tortuous and mildly calcified superficial femoral artery (sfa).The lesion was pre-dilated.A 7x120x130cm eluvia drug-eluting vascular stent system was selected.The stent was advanced through the 7fr introducer sheath on the 0.035 zip wire; however resistance was met.The stent did not advance further or retreat.The stent prematurely deployed and the entire system was removed.The procedure was completed with another stent.There were no patient complications reported and the patient's status was stable.

• 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: 9948291
• MDR Text Key: 187220056
• Report Number: 2134265-2020-04850
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024062981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR