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

Model Number	H7493911416300
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	01/23/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient presented due to unstable angina (braunwald classification: iiib).Subsequently, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion# 1 was a de novo lesion located in the proximal left anterior descending artery with 75% stenosis and was 10mm long with a reference vessel diameter of 3.50 mm.The lesion was treated with direct placement of 3.00x16mm promus element¿ plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient expired.Per death certificate, the patient died due to atherosclerotic heart disease.The other significant conditions contributing to the death of the patient were congestive heart failure, atrial fibrillation and hypertension.Autopsy was not performed.
Additional Manufacturer Narrative
Describe event or problem, relevant tests/lab data, patient codes and device codes updated.(b)(4).
Event or Problem Description
It was further reported that per adjudication results stent thrombosis occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7271892
• Report Number: 2134265-2018-01001
• Device Sequence Number: 1847421
• Product Code: NIQ
• UDI-Device Identifier: 08714729807957
• UDI-Public: 08714729807957
• 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): 01/24/2018

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: 01/18/2013
• Device Model Number: H7493911416300
• Device Catalogue Number: 39114-1630
• Device Lot Number: 0015065375
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 05/01/2018
• 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