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

Model Number	H7493911420300
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100); Sudden Cardiac Death (2510)
Date of Event	08/15/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier: (b)(\6).Device evaluated by mfr: the device was not received 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 or Problem Description
Same case as mdr# 2134265-2017-03331 and 2134265-2017-03332.(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient's qualifying condition was unstable angina.Prior to procedure, the patient was found to have abnormal fractional flow reserve indicative of ischemia and the patient was referred for cardiac catheterization.On the same day, the index procedure was performed.Target lesion #1 was located in the mid left anterior descending artery (lad) with 70% stenosis and was 16 mm long with a reference vessel diameter of 3.00 mm.Target lesion #1 was treated with pre-dilatation and placement of 3.00x20mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was located in the mid right coronary artery (rca) with 65% stenosis and was 10 mm long with a reference vessel diameter of 3.5 mm.Target lesion #2 was treated with pre-dilatation and placement of 3.50x12mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #3 was located in the proximal rca with 75% stenosis and was 12 mm long with a reference vessel diameter of 3.5 mm.Target lesion #3 was treated with pre-dilatation and placement of 3.50x20mm study stent.Following post-dilatation, residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient died on an unknown date and the cause of death was also unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the patient died due to worsening coronary artery disease (cad) at home.Per death certificate, the immediate cause of death was 'atherosclerotic cardiovascular disease' due to the consequence of 'ventricular fibrillation'.Autopsy was not performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further adjudicated that in (b)(6) 2016, stent thrombosis and cardiac death occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6479614
• Report Number: 2134265-2017-03330
• Device Sequence Number: 19096144
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: (01)08714729807964(17)20130729(10)15511519
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2017

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: 07/29/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 15511519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided; 07/25/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/04/2017; 08/10/2017
• 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: 65 YR