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

Model Number H7493911612300

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

Patient Problems Cardiac Arrest (1762); Cardiomyopathy (1764); Death (1802); Cardiogenic Shock (2262)

Event Date 01/04/2016

Event Type  Death  

Manufacturer Narrative

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 most probable root cause was unable to be determined.(b)(4).

Event Description

(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a de novo and ostial lesion located in left internal mammary artery (lima) to distal left anterior descending (lad) artery with 80% stenosis and was 10mm long and reference vessel diameter of 3mm.The target lesion with direct placement of a 3.00x12mm promus element¿ plus stent with 0% residual stenosis.On the following day, the patient was discharged on aspirin.In (b)(6) 2015, the patient presented to the hospital with multiple cardiac arrests, and was in cardiogenic shock.The patient also had respiratory failure, renal failure, anoxic encephalopathy, severe ischemic cardiomyopathy, bullous lesions of staphylococcus epidermidis and pneumonia at the time of hospitalization.Multiple consults were involved including nephrology, critical care, infectious disease, neurology, and cardiology.The patient was intubated and put on ventilator support and was placed on pressors and broad spectrum antibiotics.Despite all aggressive measures, the patient's condition never improved.She was found to have hypoxic encephalopathy and never recovered.Four days after, the patient's family opted to withdraw care and the patient expired due to cardiac arrest.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6278716
• MDR Text Key: 65768377
• Report Number: 2134265-2017-00048
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2013
• Device Model Number: H7493911612300
• Device Catalogue Number: 39116-1230
• Device Lot Number: 15520507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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; Hospitalization; Required Intervention
• Patient Age: 61 YR