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

Model Number	H7493911424270
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)
Date of Event	02/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is 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 or Problem Description
(b)(4).It was reported that the patient died.In (b)(6) 2013, the patient was referred for cardiac catheterization and coronary angiography revealed 90% stenosis in mid right coronary artery (rca).Subsequently, index procedure was performed.The target lesion was located in the mid rca with 90 % stenosis and was 16mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of 2.75x24mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin, clopidogrel and prasugrel.In (b)(6) 2017, the patient expired.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that cause of death was unknown, death certificate was not available and it is unknown if an autopsy was performed.However, per adjudication, stent thrombosis occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6433099
• Report Number: 2134265-2017-02501
• Device Sequence Number: 16390408
• Product Code: NIQ
• UDI-Device Identifier: 08714729807919
• UDI-Public: (01)08714729807919(17)20131216(10)0015811508
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/06/2017

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: 12/16/2013
• Device Model Number: H7493911424270
• Device Catalogue Number: 39114-2427
• Device Lot Number: 0015811508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 07/31/2017
• 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: 66 YR