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

Model Number H7493927615400

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. 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. (b)(4).

Event Description

Same case as mdrs# 2134265-2017-10914, 2134265-2017-10915, 2134265-2017-10916, 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: 7010921
• MDR Text Key: 91408048
• Report Number: 2134265-2017-10917
• 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

• 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

• Device Model Number: H7493927615400
• Device Catalogue Number: 39276-1540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 11/08/2017 Patient Sequence Number: 1