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

Model Number H7493927620350

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

Patient Problems Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 10/20/2017

Event Type  Death  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Bsc id# (b)(4).

Event Description

Same case as mdrs# 2134265-2017-10914, 2134265-2017-10915, 2134265-2017-10917, 2134265-2017-10918, 2134265-2017-10920, 2134265-2017-10930, 2134265-2017-10932, 2134265-2017-10933, 2134265-2017-10934.It was reported that patient death occurred.The target lesion was located in the left main (lm) to mid left anterior descending artery (lad).The lm to mid lad were rotablated successfully using a 1.75 rotalink burr, a rotalink advancer, and a 300 cm rotawire per the directions for use (dfu).The lesion was dilated with a 3.0x20mm nc emerge® balloon.A 3.0x20mm synergy¿ stent was introduced but failed to cross the mid lad lesion.The lesion was dilated with a 3.5x20mm nc emerge® balloon and the same 3.0x20mm synergy¿ stent was successfully delivered.A 3.0x24mm synergy¿ stent was deployed in the proximal lad and a 4.0x20mm promus premier¿ stent was deployed in the proximal lad into the lm.A new 3.5x20mm nc emerge® balloon was used to post dilate the stents in the lad and a 4.0x15mm nc emerge® balloon was used to post dilate the promus premier¿ stent in the lm.While the 4.0x15mm nc emerge® balloon was being inflated briefly, the patient complained of chest pain.The physician did a final inflation at the very proximal end of the promus premier¿ stent.As the physician took a cine of the final result, the patient's blood pressure dropped and the patient became non responsive.A medical emergency was called but the patient died.

• 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: 7010894
• MDR Text Key: 91408912
• Report Number: 2134265-2017-10916
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493927620350
• Device Catalogue Number: 39276-2035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• 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): Death