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

Model Number H7493919112150

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

Patient Problems Bradycardia (1751); Death (1802); Ventricular Fibrillation (2130); Vascular Dissection (3160)

Event Date 09/06/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by manufacturer: the 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: 2134265-2017-09801. Same case as mdr id: 2134265-2017-09500. It was reported a vessel dissection occurred and the patient experienced bradycardia, hypotension, and died. The physician was able to obtain access via the right femoral artery, left femoral artery, right femoral vein, left femoral vein, with placement of 7-french in the right femoral artery, 13-french in the left femoral artery which was closed with two percloses with placement of 6-french sheath, and 6-french sheathes in the venous lines. The physician placed a 5f 100cm temporary balloon bipolor pacing catheter with setting at rate - 45, ma 5. A ventricular assist device (vad) was also placed into the left ventricle and started up to 2. 5 l/min. Intervention of the left circumflex (cx) artery was started with balloon angioplasty using a 1. 5 x 12mm emerge balloon advanced across the mid cx. The guidewire was removed and exchanged for a rotawire and the emerge balloon was removed. A 1. 25mm rotalink plus was advanced and rotational atherectomy was started in the mid cx for 17 seconds at 160000rpm's. A significant dissection was noticed and the physician decided to stent the artery with a 2. 5 x 22mm non bsc stent protruding into the dissection. An echocardiogram was performed to verify no evidence of a perforation. The guidewire was repositioned through the stent strut and was tacked using the stent delivery balloon inflated to 9atm for 2 minutes 48 seconds with no extravasation present. The patient went in to ventricular fibrillation and received two defibrillator shocks, initially at 200 and then with 360 joules. The physician was able to stabilize the patient by occluding the left cx with a 2. 5 x 12mm emerge balloon, inflated three times (14 atm for 2 minutes 2 seconds, 20 atm for 25 seconds and 20 atm for 11 seconds) with resumed timi 3 flow. The physician then decided to proceed with treatment in the left anterior descending (lad) artery. A rotawire was advanced into the left main. A 1. 25mm burr was advanced to the proximal lad and rotational atherectomy was performed twice for 15 seconds at 160000 rpm. At this time the patient did not require a pacemaker. There was improved results and the physician decided to implant a 2. 75 x 22mm non-bsc stent which was deployed at15 atm for 20 seconds. The patient started losing blood pressure during the inflation. The patient had excellent results of timi 3flow with 0% stenosis, with the exception of chronic total occlusion (cto) of the distal lad. The patient was hemodynamically stable with a systolic blood pressure over 100. The vad and the pacemaker were removed. The patient was hemodynamically stable for about 20 minutes when the patient became bradycardic and hypotensive. The physician was able to implant the pacemaker back into the right ventricle and started pacing the patient at 80 beats per minute. However, this did not improve the patient¿s hemodynamics. The patient proceeded to develop ventricular fibrillation and coded for about 30 minutes. Chest compressions, approximately 12 defibrillator shocks, and medications including atropine bolus and amiodarone, epinephrine, norepinephrine were administered. Despite resuscitation, staff was not able to resume either normal sinus rhythm or paced rhythm for more than 10 seconds at a time. The physician pronounced the patient's death at approximately 5:25 pm.

• Brand Name: 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: 6911709
• MDR Text Key: 88060131
• Report Number: 2134265-2017-09802
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: H7493919112150
• Device Catalogue Number: 39191-1215
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/08/2017
• 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: 10/03/2017 Patient Sequence Number: 1

Treatment

.014 X 300CM PROWATER GUIDEWIRE - ABBOTT; 1.25ROTALINK PLUS; EXTRA SUPPORT ROTAWIRE - BSC