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

Model Number	H7493911428270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); ST Segment Elevation (2059)
Date of Event	02/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the device was not returned 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).It was reported that myocardial infarction occurred.In (b)(6) 2012, coronary angiography and index procedure were preformed.The target lesion was a de novo lesion located in the distal right coronary artery (rca) with 80% stenosis and was 20mm long with a reference vessel diameter of 3.25mm.The lesion was treated with placement of a 2.75x28mm promus element¿ plus drug-eluting stent.Following post-dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient presented to the hospital with severe chest pain.Cardiac enzyme values were noted to be elevated (peak ck total = 2950 iu/l, uln = 174 iu/l; peak ck-mb = 357.3 ng/ml, uln =5.0 ng/ml; peak troponin t = 36.58 ng/ml, uln = 0.1 ng/ml) and site reported an event of acute inferolateral myocardial infarction.Ekg revealed diffuse st depression with st elevation and avr.Subsequently the patient was referred for cardiac catheterization.Coronary angiography revealed patent study stent in distal portion of rca; jailed right posterior descending artery (rpda) with 90% distal disease; 60% proximal disease in right posterolateral (rpl).The patient was also noted to have severe aortic valve stenosis.Considering the progression of aortic stenosis in combination with coronary disease it was planned for an aortic valve replacement and bypass surgery on a later date.Seven days later, the event was considered resolved.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6293893
• Report Number: 2134265-2017-00381
• Device Sequence Number: 16306114
• Product Code: NIQ
• UDI-Device Identifier: 08714729807926
• UDI-Public: (01)08714729807926(17)20130910(10)0015605873
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 01/10/2017

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: H7493911428270
• Device Catalogue Number: 39114-2827
• Device Lot Number: 0015605873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/01/2017
• 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: Required Intervention
• Patient Age: 41 YR