MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

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

Patient Problems Angina (1710); Chest Pain (1776); Dyspnea (1816); Restenosis (4576)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Agent ide study: it was reported angina and in-stent-restenosis (isr) occurred.On (b)(6) 2006, the 2.50 x 16mm taxus drug eluting stent was implanted in the mid left anterior descending artery (lad).Angioplasty to the first diagonal was performed using a 2.00 mm x 15 mm maverick balloon.Additionally, a 2.50 mm x 20 mm synergy stent was implanted at the distal left circumflex (lcx) and a 2.50 mm x 16 mm synergy stent at the mid lcx.On (b)(6) 2022, the subject presented with complaints of worsening angina over a period of two months associated with shortness of breath.The index procedure was performed the same day.The target lesion was located at the mid lad and was 10 mm long with a reference vessel diameter of 2.0 mm.The target lesion was predilated using 3.00 mm x 12 mm balloon.Following pre-dilation, the lesion was treated successfully with a 3.0 mm x 15 mm nc emerge study device, with 10% residual stenosis and timi flow of 3.The subject was discharged on aspirin and clopidogrel.On (b)(6) 2024, the subject complained of increased fatigue as well as shortness of breath with exertion over the period of 1- 2 weeks.On (b)(6) 2024, the subject experienced chest pain.At the time of the event the subject was on clopidogrel.Due to extensive cardiac history, the subject was referred for cardiac catheterization which revealed 60% isr at the mid and distal lad.Following pre-dilation of the proximal and distal lad, intravascular ultrasound was performed which revealed minimum lumen area at the mid lad and severe calcification.The distal lad was later treated with a 2.75 mm x 26 mm non-boston scientific (non-bsc) drug eluting stent and was post dilated with a 2.75 mm x 20 mm nc balloon resulting in residual stenosis of 0% and timi flow 3.The 60% isr in the mid lad was treated with a 3.50 mm x 12 mm lithotripsy balloon and a 4.00 mm x 34 mm non-bsc drug eluting stent and was post dilated with 4.00 mm x 15 mm nc balloon.The residual stenosis was 0% and timi flow was 3.The event was resolved, and the subject was discharged.

• Brand Name: TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18989611
• MDR Text Key: 338740958
• Report Number: 2124215-2024-18611
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: 03/08/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White