MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TAXUS LIBERTE; CORONARY DRUG-ELUTING STENT

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

Patient Problems Angina (1710); Restenosis (4576)

Event Date 11/02/2021

Event Type  Injury  

Event Description

(b)(4).It was reported that stable angina and in stent restenosis (isr) occurred.On an unknown date the lad was treated with angioplasty using a 3mm x 20mm taxus drug eluting stent and a 2.75mm x 32mm taxus drug eluting stent.On (b)(6) 2021, the subject presented for the index procedure with stable angina.Angiography revealed 90% in stent restenosis of the lad.Heparin or other antithrombotic medication were administered at the time of the index procedure.The subject was on a prior regime of aspirin (>= 72 hours) and antiplatelet other than aspirin >=72 hours) medications at the time of the index procedure.The target lesion was located in the proximal lad and was 10mm long with a reference vessel diameter of 2.75mm.The lesion was predilated with a 2.5mm x 15mm balloon with 30% residual stenosis and timi flow 3.Following pre dilation, the lesion was treated with a 2.50mm x 30mm study device successfully with 0% residual stenosis and timi flow 3.Post dilation was not performed.On 03 nov 2021, the subject was discharged on aspirin and clopidogrel.

• Brand Name: TAXUS LIBERTE
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 13863601
• MDR Text Key: 288091764
• Report Number: 2134265-2022-03290
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 03/04/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Race: White