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

Model Number UNK432

Device Problem Occlusion Within Device (1423)

Patient Problems Bradycardia (1751); Myocardial Infarction (1969); Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The device was not received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id: 2134265-2015-06594.(b)(4) clinical study.It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2005, a 2.5x20mm taxus stent was implanted in the distal left anterior descending (lad) artery.In (b)(6) 2014, the patient presented with unstable angina and a 3.00x20.00mm promus element plus stent was implanted in proximal right coronary artery (rca).In (b)(6) 2015, the patient presented due to chest tightness.Patient's electrocardiogram (ecg) shows a normal sinus rhythm, q wave in lead and no other st-t wave changes, and the final impression was sinus bradycardia.Patient's coronary angiography revealed 70% apical stenosis within previously placed 2.5x20mm taxus stent in distal lad and 90% isr of the previously placed 3.0x20mm promus element plus stent in the proximal rca.The 90% stenosis in the previously placed 3.0x20mm promus element plus stent in proximal rca was treated with placement of a 3.00x20.00mm promus drug eluting stent.Following post-dilatation, residual stenosis was 0%.No treatment was done for the isr of the previously placed taxus stent in distal lad.In (b)(6) 2015, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.

• Brand Name: TAXUS EXPRESS2 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5112115
• MDR Text Key: 27051756
• Report Number: 2134265-2015-06587
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• 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): Other
• Patient Age: 72 YR