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

Model Number	H7493911612270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Angina (1710)
Date of Event	11/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.The complaint device was not received for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that patient experienced angina.In (b)(6) 2013, the patient presented due to unstable angina and myocardial infarction and patient was referred urgently for cardiac catheterization.Subsequently,coronary angiography and index were performed.Target lesion was a de novo lesion located in the proximal left anterior descending artery with 100% stenosis and was 8mm long with a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 2.75mm x 2mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0% and timi 3 flow noted.Three days post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2017, the patient presented to the emergency department with the symptoms of unstable angina and was hospitalized on the same day.Angio without revascularization was performed in response to the event.On the following day, the event was considered as resolved and the patient was discharged from the hospital.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7335025
• Report Number: 2134265-2018-01731
• Device Sequence Number: 18957773
• Product Code: NIQ
• UDI-Device Identifier: 08714729807438
• UDI-Public: 08714729807438
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 02/14/2018

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: 09/09/2013
• Device Model Number: H7493911612270
• Device Catalogue Number: 39116-1227
• Device Lot Number: 15600380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/13/2018
• 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: Hospitalization
• Patient Age: 60 YR