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

Model Number	H7493911412400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Occlusion (1984)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: device not returned therefore analysis of complaint device could not be performed.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
Same case as mdr ids: 2134265-2017-03280, 2134265-2017-03281, and 2134265-2017-03282.(b)(4) clinical study.It was reported that coronary artery disease, stenosis, and target vessel revascularization occurred.In (b)(6) 2012, the patient presented due to unstable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion was a de novo and restenotic lesion located in the proximal right coronary artery (rca) with 75% stenosis and was 10.00mm long with a reference vessel diameter of 4.5 mm.The lesion #2 was treated with direct stent placement using a 4.00x12.0mm promus element¿ plus drug-eluting study stent, with 0% residual stenosis.A stent was also placed in the left main coronary artery (lmca).One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, a 3.5x38mm promus element stent was implanted in the mid right coronary artery (rca).Five days later another 3.5x38mm promus element was implanted in the mid right coronary artery (rca).In (b)(6) 2016, a 3.0x28mm synergy mr stent was implanted in the mid right coronary artery (rca).In (b)(6) 2017, the patient presented to hospital with shortness of breath, chest pain and fatigue and the patient was hospitalized on the same day.Subsequently, the planned procedure of redo-coronary artery bypass graft was performed using reverse saphenous vein graft (svg) to right dominant posterior descending artery (r-pda) to treat stenosis located from proximal rca to distal rca.Six days from the onset of symptoms, the event was considered resolved and the patient was discharged on the same day.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6463449
• Report Number: 2134265-2017-03279
• Device Sequence Number: 10882363
• Product Code: NIQ
• UDI-Device Identifier: 08714729808060
• UDI-Public: (01)08714729808060(17)20130620(10)15418437
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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: 06/20/2013
• Device Model Number: H7493911412400
• Device Catalogue Number: 39114-1240
• Device Lot Number: 15418437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/06/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR