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

Model Number 9388

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

Patient Problems Cardiac Arrest (1762); Death (1802); Obstruction/Occlusion (2422)

Event Date 01/06/2020

Event Type  Death  

Manufacturer Narrative

Patient identifier: (b)(6).Device is combination product.

Event Description

It was reported that obstruction, cardiac arrest, and patient death occurred.The patient presented with severe chest pain and in cardiogenic shock with blood pressure (bp) 80/60 mm/hg.Angiography revealed a chronic total occlusion (cto) of the right coronary artery (rca) and a 100% occlusion in the left anterior descending artery (lad) with distal thrombolysis in myocardial infarction (timi) score of 0.A percutaneous transluminal coronary angioplasty was performed on the 100% stenosed left anterior descending artery (lad) which was calcified and tortuous.Two promus element plus stents, 2.75 x 24mm and 2.50x16mm, were deployed in the lad.Post deployment, the patient had slow flow and went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed for thirty minutes but the patient was unable to be revived.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9647798
• MDR Text Key: 176991044
• Report Number: 2134265-2020-00709
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 9388
• Device Catalogue Number: 9388
• Device Lot Number: 0022617839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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: 65 YR