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

Model Number	9323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 stable angina.Prior to procedure, the patient was found to have evidences indicative of ischemia and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the 1st obtuse marginal (om) branch with 90% stenosis and was 15mm long with a reference vessel diameter of 3.00mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 12mm study stent followed by post dilation and the residual stenosis was found to be 5%.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient died.The cause of death has been reported as sudden death.
Additional Manufacturer Narrative
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 stable angina.Prior to procedure, the patient was found to have evidences indicative of ischemia and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the 1st obtuse marginal (om) branch with 90% stenosis and was 15mm long with a reference vessel diameter of 3.00mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 12mm study stent followed by post dilation and the residual stenosis was found to be 5%.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient died.The cause of death has been reported as sudden death.It was further reported that in (b)(6) 2018, the patient suddenly felt sick and collapsed.The cause of death was unknown.

• 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: 7802503
• Report Number: 2134265-2018-60278
• Device Sequence Number: 16735722
• Product Code: NIQ
• UDI-Device Identifier: 08714729807940
• UDI-Public: 08714729807940
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• 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): 10/10/2018

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: 09/08/2013
• Device Model Number: 9323
• Device Catalogue Number: 9323
• Device Lot Number: 15597831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: 61 YR