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

Model Number	H7493911438270
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	03/28/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures and current controls as per the product specification.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 expired.In (b)(6) 2012, the patient was diagnosed with unstable angina along with silent ischemia and was referred for cardiac catheterization.Target lesion #1 was a de novo lesion located in the proximal left anterior descending (lad) artery (cass site # 12) with 70% stenosis and was 28 mm long with a reference vessel diameter of 2.75 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.75 x 38 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.The patient was discharged the following day on aspirin and clopidogrel.However, in (b)(6) of 2016 the patient expired.The cause of death is unknown.
Additional Manufacturer Narrative
Describe event or problem, patient codes, and device codes updated.(b)(4).
Event or Problem Description
It was further reported that possible stent thrombosis occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6883815
• Report Number: 2134265-2017-09242
• Device Sequence Number: 566823
• Product Code: NIQ
• UDI-Device Identifier: 08714729823742
• UDI-Public: 08714729823742
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• 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: 02/20/2013
• Device Model Number: H7493911438270
• Device Catalogue Number: 39114-3827
• Device Lot Number: 15144747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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: 52 YR