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	Cardiac Arrest (1762); Death (1802); Thrombosis (2100)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.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
Promus element plus clinical study.It was reported that the patient died.In (b)(6) 2013, the patient's qualifying condition was unstable angina and the patient was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the mid right coronary artery (rca) with 90% stenosis and was 16 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 20 mm promus element¿ plus stent with 0% residual stenosis.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient died due to natural cause.Per death certificate, the immediate cause of death was "apparent heart attack".No autopsy was performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported per adjudication results that stent thrombosis (st) occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6413134
• Report Number: 2134265-2017-02167
• Device Sequence Number: 10994376
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: (01)08714729807964(17)20131016(10)0015706972
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/27/2017

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: 10/16/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 0015706972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/17/2017
• 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: 64 YR