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

Model Number	H7493911424250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chest Tightness/Pressure (2463)
Date of Event	09/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id #: 2134265-2017-01569.(b)(6)clinical study.It was reported that chest discomfort occurred.In (b)(6) 2013, the patient presented due to chest pain and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion# 1 was a de novo lesion, located in the mid left anterior descending artery (lad) with 95% stenosis and was 6 mm long with a reference vessel diameter of 2.25mm.The lesion was treated with direct stent placement using 2.25x8mm promus element¿ plus stent resulting in 0% stenosis.The target lesion #2 was a de novo lesion located in the proximal left circumflex (lcx) with 85% stenosis and was 22mm long with a reference vessel diameter of 2.50 mm.The lesion was treated with direct stent placement using 2.50x24mm promus element¿ plus stent resulting in 0% stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented for follow-up and had ongoing symptoms of exertional and resting chest heaviness.The symptoms got relieved by nitroglycerine and the patient was referred for cardiac catheterization.99% in-stent restenosis of the mid lad was treated with pre-dilatation and placement of a 2.50x20mm synergy drug-eluting stent.Additionally on the same day, 80% ostial stenosis of left main coronary artery (lmca) was treated with direct placement of a synergy 3.0x16mm drug-eluting stent.On the following day, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6362407
• Report Number: 2134265-2017-01572
• Device Sequence Number: 674719
• Product Code: NIQ
• UDI-Device Identifier: 08714729807858
• UDI-Public: (01)08714729807858(17)20130802(10)15511281
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/09/2017

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: 08/02/2013
• Device Model Number: H7493911424250
• Device Catalogue Number: 39114-2425
• Device Lot Number: 15511281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 02/27/2017
• 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: 69 YR