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

Model Number 24653

Device Problem Activation Failure (3270)

Patient Problem Thrombosis (2100)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient was in her 70s.

Event Description

It was reported that the stent had insufficient expansion and thrombosis occurred.Two 6 x 120 x 130 and one 6 x 40 x 130 eluvia drug-eluting vascular stent systems were implanted in the totally occluded, moderately calcified, and moderately tortuous superficial femoral artery (sfa).Post-dilation was performed after stent placement.Thrombus developed inside all three stents.The thrombus was removed through thrombus suction was performed and the procedure was completed.Two weeks later, the thrombus appeared in all three stents again.Thrombus suction and ballooning were performed.The stent edge at the beginning of the sfa was insufficiently expanded and was expanded by ballooning.The physician believed the thrombus could have been caused due to insufficient stent expansion in the proximal sfa.No further patient complications were reported.

• 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: 10373396
• MDR Text Key: 201874651
• Report Number: 2134265-2020-10550
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024941648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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): Required Intervention