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

Model Number	9327
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Angina (1710); Reocclusion (1985); Obstruction/Occlusion (2422)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) clinical study.It was reported that unstable angina and in-stent restenosis (isr) occurred.In (b)(6) 2013, the patient's qualifying condition was unstable angina.Prior to procedure, the patient was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) with 95% stenosis and was 15 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50x20mm stent, following post dilation the residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient had presented for cardiovascular consultation with the complaint of chest pain, shortness of breath and chest discomfort.The patient was referred for coronary angiography for further evaluation and management.Seven days later coronary angiography revealed 20% in-stent restenosis of the previously placed study stent in proximal portion, minor plaquing in mid and distal portion; minor plaquing in posterior descending artery and posterior left ventricular artery.Patient was recommended to take the prescribed medications.On the same day, the patient was discharged on dual antiplatelet therapy.

• 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: 7847957
• Report Number: 2134265-2018-60776
• Device Sequence Number: 19121564
• Product Code: NIQ
• UDI-Device Identifier: 08714729808022
• UDI-Public: 08714729808022
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/05/2018

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: 09/13/2013
• Device Model Number: 9327
• Device Catalogue Number: 9327
• Device Lot Number: 15612811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/05/2018
• 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: Other
• Patient Age: 53 YR