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

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

Patient Problem Reocclusion (1985)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Patient age: born in (b)(6).

Event Description

It was reported that there was in-stent restenosis.The index procedure was performed on (b)(6) 2016.The target vessel was 5mm diameter.A 6mmx150mm eluvia stent was selected for use to treat a previously restenosed lesion.The stent was placed and afterwards the target vessel had a distal diameter of about 3-5mm.11 months after the index procedure, there was reocclusion seen in the target vessel.Lysis therapy was performed and the vessel was open again with positive remodeling recognized.On (b)(6) 2018, the stent had reocclusion again.Lysis therapy was repeated and the following day angiography showed the stent was open with positive remodeling still present.Four weeks later, the stent was reoccluded again.The physician does not have another treatment planned at this time.According to the physician, the origin of the restenosis is not clear.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7954047
• MDR Text Key: 123353454
• Report Number: 2134265-2018-61554
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• 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): Required Intervention