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

Model Number H7493911420270

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

Patient Problems Cardiomyopathy (1764); Death (1802); Heart Failure (2206)

Event Date 08/21/2017

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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is anticipated procedural complication as the reported event is due to a known physiological effect of the procedure noted within the product directions for use (dfu) and/or device labeling.(b)(4).

Event Description

(b)(6) study; it was reported that following a coronary artery drug eluting stenting treatment procedure, the patient had biventricular heart failure and expired.In (b)(6) 2012, the patient presented due to unstable angina (braunwald classification: iiib) and was referred for cardiac catheterization.The de novo target lesion was located in the mid left anterior descending artery (mid lad) with 70% stenosis and was 20mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilation and placement of a 2.75x20mm promus element plus stent, with 0% residual stenosis following post-dilation.The patient was discharged on aspirin the next day.In (b)(6) 2017, the patient expired.Per death certificate, the primary and immediate cause of death was ¿biventricular heart failure secondary to ischemic cardiomyopathy¿.It was confirmed that no autopsy was performed.

• 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: 6892993
• MDR Text Key: 87293057
• Report Number: 2134265-2017-09244
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729807902
• UDI-Public: 08714729807902
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2012
• Device Model Number: H7493911420270
• Device Catalogue Number: 39114-2027
• Device Lot Number: 0014960489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2012
• 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
• Patient Age: 68 YR