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

Model Number	H7493911428250
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	05/16/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).Device is a combination product.Device evaluated by mfr: 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
(b)(6) study.It was reported that the patient died.In (b)(6) 2013, the patient's qualifying condition was stable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed on the same day.The target lesion was located in the distal left circumflex artery (lcx) with 80% stenosis and was 28 mm long with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 28 mm study stent with 10% residual stenosis.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient expired at 12:21 am due to unknown cause.
Additional Manufacturer Narrative
Describe event or problem updated.(b)(4).
Event or Problem Description
It was further reported that the caused of death was "cardiopulmonary".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that 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: 6630618
• Report Number: 2134265-2017-05751
• Device Sequence Number: 16388579
• Product Code: NIQ
• UDI-Device Identifier: 08714729807865
• UDI-Public: (01)08714729807865(17)20130910(10)15609357
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/22/2017

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: 09/10/2013
• Device Model Number: H7493911428250
• Device Catalogue Number: 39114-2825
• Device Lot Number: 15609357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017; 10/30/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/12/2017; 11/20/2017
• 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: 81 YR