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

Model Number	H7493911420270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiomyopathy (1764); Death (1802); Heart Failure (2206)
Date of Event	08/21/2017
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6892993
• Report Number: 2134265-2017-09244
• Device Sequence Number: 705996
• Product Code: NIQ
• UDI-Device Identifier: 08714729807902
• UDI-Public: 08714729807902
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR