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

Model Number	H7493911620250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.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# 2134265-2016-11768.(b)(4) study.It was reported that restenosis occurred.In (b)(6) 2012, the patient presented with unstable angina and myocardial infarction (mi).Subsequently, coronary angiography was performed.Target lesion #1 was a de novo lesion located in the mid left anterior descending (lad) artery with 100% stenosis and was 15mm long with a reference vessel diameter of 2.5mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50x20mm promus element¿ plus drug-eluting stent, with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the mid lad with 80% stenosis and was 10mm long with a reference vessel diameter of 2.5mm.Target lesion #2 was treated with direct placement of a 2.50x12mm promus element¿ plus drug-eluting stent, with 0% residual stenosis.Three days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was diagnosed with coronary artery disease and was hospitalized on the same day.Subsequently, coronary angiography was performed which revealed an 80% occlusion in the mid segment of the lad.On the same day, the patient underwent coronary artery bypass graft (cabg) including left internal mammary artery (lima) to lad and saphenous vein graft (svg) to the first diagonal branch for treating the event.Four days later, 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: 6167411
• Report Number: 2134265-2016-11767
• Device Sequence Number: 10776445
• Product Code: NIQ
• UDI-Device Identifier: 08714729807377
• UDI-Public: (01)08714729807377(17)20130827(10)0015569241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/30/2016

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: 08/27/2013
• Device Model Number: H7493911620250
• Device Catalogue Number: 39116-2025
• Device Lot Number: 0015569241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/12/2016
• 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: 45 YR