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

Model Number	9335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Ischemia (1942); Reocclusion (1985)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that patient experienced angina with ischemia and target vessel revascularization occurred.In (b)(6) 2013, the patient's qualifying condition was stable angina.Abnormal stress test or imaging stress test indicated ischemia prior to procedure and the patient was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the distal right coronary artery (rca) with 75% stenosis and was 18 mm long with a reference vessel diameter of 3.38 mm.The lesion was treated with pre-dilatation and deployment of a 3.00 x 20 mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was located in the proximal rca with 98% stenosis and was 30 mm long with a reference vessel diameter of 3.38 mm.Target lesion #2 was treated with pre-dilatation and deployment of a 3.50 x 32/38 mm study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #3 was located in the 1st obtuse marginal with 86% stenosis and was 34 mm long with a reference vessel diameter of 2.47 mm.Target lesion #3 was treated with pre-dilatation and placement of a 2.50 x 32/38 mm study stent.Following post-dilatation, residual stenosis was 0%.After a day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the subject presented to hospital due to chest pain and was admitted on the same day for further evaluation.Subsequently, stress test was performed which revealed evidence of cardiac ischemia.The 66% stenosis located in mid rca was treated with placement of a drug eluting stent with 0% residual stenosis and timi 3 flow.The next day, the patient was discharged on clopidogrel.

• Brand Name: PROMUS ELEMENT PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8009663
• Report Number: 2134265-2018-62299
• Device Sequence Number: 1654525
• Product Code: NIQ
• UDI-Device Identifier: 08714729823766
• UDI-Public: 08714729823766
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: 10/28/2013
• Device Model Number: 9335
• Device Catalogue Number: 9335
• Device Lot Number: 15720701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/26/2018
• 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: Required Intervention
• Patient Age: 55 YR