MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927615350

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

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 01/16/2017

Event Type  Death  

Manufacturer Narrative

The complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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# 2134265-2017-00682, 2134265-2017-00686, and 2134265-2017-00761.It was reported that the patient died.The patient presented with myocardial infarction (mi) and angiogram was performed.One target lesion was identified as a total occlusion in the right coronary artery (rca), two small target lesions were identified in the left anterior descending (lad) artery, and a small non-dominant target lesion in the circumflex artery.After a temporary pacemaker was placed, a 5fr sheath was inserted and a 2.50mm x 20mm emerge¿ balloon catheter was advanced and pre-dilatation was performed to the two lesions in the lad.A 2.75 x 32 synergy¿ drug-eluting stent was then implanted in the first lad lesion and post-dilated with a 3.50mm x 15mm nc emerge® balloon catheter.However, upon stenting of the second lad lesion with a 3.00 x 20 synergy¿ drug-eluting stent, the patient crashed with the pressures and pulse dropped.The procedure was stopped and advanced life support (als) was performed with emergency drugs administered.The patient was unable to be recovered and subsequently passed away.The official cause of death was infarction.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6331704
• MDR Text Key: 67476763
• Report Number: 2134265-2017-00762
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: SIMILAR
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: H7493927615350
• Device Catalogue Number: 39276-1535
• Device Lot Number: 19798393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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): Death
• Patient Age: 69 YR