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

Model Number UNK433

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Reocclusion (1985)

Event Date 01/31/2015

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The complaint device was not received for analysis.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id#: 2134265-2015-01114.(b)(4) clinical study.It was reported that angina and in-stent restenosis (isr) occurred.In (b)(6) 2012, a taxus liberte paclitaxel was implanted in the mid right coronary artery (rca).In (b)(6) 2012, coronary angiography and the index procedure were performed.The target lesion was a de novo lesion located in the mid left anterior descending (lad) artery with 99% stenosis and was 40 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct placement of 2.50 mm x 38 mm and 3.00 mm x 16 mm promus element¿ plus stents in an overlapping fashion.Following post-dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel with consideration of intervention to the disease right coronary at a later time.In (b)(6) 2015, the patient was presented to the emergency department with complaints of chest pain, history of exertional dyspnea and fatigue.Cardiac enzymes were negative while computed tomography (ct) angiogram and electrocardiogram (ekg) showed no acute changes.The patient was noted to have permanent atrial fibrillation with controlled ventricular response.Subsequently, patient was referred for cardiac catheterization.The following day, the patient¿s coronary angiography revealed 70% proximal in-stent restenosis (isr) of the previously placed 3.00 mm x 16 mm promus element¿ plus stent noted in the proximal and mid segment; widely patent 2.50 mm x 38 mm promus element¿ plus.There was 60-70% focal (isr) of taxus liberte paclitaxel stent in mid portion of right coronary artery (rca).The patient was referred for a scheduled coronary artery bypass graft (cabg), considering his triple-vessel coronary artery disease.After three days, the 2-vessel cabg was performed including left internal mammary artery (lima) to left anterior descending artery (lad) and reverse saphenous vein graft (svg) to right posterolateral (rpl).Seven days post procedure, the event was considered resolved the patient was discharged on aspirin.

• Brand Name: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6918717
• MDR Text Key: 88374692
• Report Number: 2134265-2017-10031
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/05/2017
• 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
• Patient Age: 63 YR