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

Model Number	9327
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Encephalopathy (1833)
Date of Event	06/19/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was unstable angina.Prior to procedure, the patient was noted to have elevated biomarkers indicative of ischemia and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion #1 was located in the ramus with 70% stenosis and was 15 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.5x20mm study stent with 5% residual stenosis, and timi 3 flow.The target lesion # 2 was located in the 1st obtuse marginal with 70% stenosis and was 22mm long with a reference vessel diameter of 2.25mm.The lesion was treated with pre-dilatation and placement of a 2.25 x 28 mm study stent with 1% residual stenosis and timi 3 flow.Three days later, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was admitted in the hospital.Three days later, the patient died due to cardiac arrest.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device is a combination product.
Event or Problem Description
Evolve ii clinical study- it was reported that the patient died.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was unstable angina.Prior to procedure, the patient was noted to have elevated biomarkers indicative of ischemia and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion #1 was located in the ramus with 70% stenosis and was 15 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.5x20mm study stent with 5% residual stenosis, and timi 3 flow.The target lesion # 2 was located in the 1st obtuse marginal with 70% stenosis and was 22mm long with a reference vessel diameter of 2.25mm.The lesion was treated with pre-dilatation and placement of a 2.25 x 28 mm study stent with 1% residual stenosis and timi 3 flow.Three days later, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was admitted in the hospital.Three days later, the patient died due to cardiac arrest.It was further reported that per death certificate, the immediate cause of death was "anoxic encephalopathy due to drowning" and not related to the study device.

• 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: 7806412
• Report Number: 2134265-2018-60372
• Device Sequence Number: 1536381
• Product Code: NIQ
• UDI-Device Identifier: 08714729807841
• UDI-Public: 08714729807841
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 10/09/2018

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: 08/19/2013
• Device Model Number: 9327
• Device Catalogue Number: 9327
• Device Lot Number: 15550336
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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: Death
• Patient Age: 76 YR