MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493918424300

Device Problem Occlusion Within Device (1423)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Thrombosis (2100); Ventricular Tachycardia (2132); Obstruction/Occlusion (2422)

Event Date 07/02/2017

Event Type  Death  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: the 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: 2134265-2017-07184.It was reported that plaque shift, stent thrombosis, cardiac arrest occurred and the patient died.Vascular access was obtained via the femoral artery.The 95% stenosed, 3x18mm, concentric, de novo target lesion was located in the non-tortuous and moderately calcified ostial left anterior descending artery (lad).Following predilitation, a 3.00x24mm promus element plus drug-eluting stent was successfully implanted in the lad and post dilated.Post deployment, it was noted that there was a plaque shift to left circumflex artery (lcx).A 2.50 x 24mm synergy drug-eluting stent was implanted in the lcx.It was also noted that stent thrombosis occurred and the patient had cardiac arrest.Kissing balloon technique was performed and the procedure was completed.However, the patient died while in the icu.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in the intensive care unit (icu), the patient developed severe chest pain followed by ventricular tachycardia.The official cause of death was cardiac arrest.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6719453
• MDR Text Key: 80220021
• Report Number: 2134265-2017-07213
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2018
• Device Model Number: H7493918424300
• Device Catalogue Number: 39184-2430
• Device Lot Number: 19894550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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