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

Model Number H7493911324350

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

Patient Problems Chest Pain (1776); Death (1802); Myocardial Infarction (1969); Renal Failure (2041); Heart Failure (2206)

Event Date 01/10/2016

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that acute myocardial infarction (ami) and cardiac arrest occurred and the patient died.In (b)(6) 2014, the patient was diagnosed with coronary heart disease (chd) and ami.The target lesion was located in the left circumflex artery.The target lesion was treated with a 3.50x24mm promus element ¿ drug-eluting stent.Postoperative follow treatment, it was noted that chest tightness and asthma had occurred many times.In (b)(6) 2016, the patient was diagnosed with chd and ami and was hospitalized on the same day.Following medical treatment, the patient was discharged.After discharge, the patient still had chest tightness and asthma.Fourteen days later, the patient was diagnosed with chd, heart failure, renal failure and pulmonary infection.The patient was treated with antiplatelet, lipid, antiarrhythmic, diuretic, anti-infective, blood transfusion, ventilator assisted therapy and concurrent bedside continuous renal replacement therapy (crrt.) in (b)(6) 2016, cardiac arrest occurred and the patient was in coma after being rescued.The patient's family asked to give up the rescue and discharge.The patient died on the day of discharge.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that this event is a duplicate of mdr# 2134265-2016-10478.

• Brand Name: PROMUS ELEMENT ¿
• 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: 7286228
• MDR Text Key: 100579309
• Report Number: 2134265-2018-01143
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2015
• Device Model Number: H7493911324350
• Device Catalogue Number: 39113-2435
• Device Lot Number: 0016628907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2014
• 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: 79 YR