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

Model Number	H7493911438300
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Death (1802); High Blood Pressure/ Hypertension (1908); Thrombosis (2100); Heart Failure (2206)
Date of Event	02/23/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Age at time of event: (b)(6) years old.Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient presented with stable angina.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the mid left anterior descending (lad) with 90% stenosis and was 34 mm long with a reference vessel diameter of 3.0 mm.The target lesion treated with direct stent placement using a 3.00 mm x 38 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient died due to natural causes.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that stent thrombosis occurred as per adjudication results.Per death certificate the immediate cause of death was due to natural causes and other significant conditions contributing to death but not resulting in the exact cause of death were diastolic heart failure, hypertension, rheumatoid arthritis, breast cancer, crohn's disease and coronary artery disease.It was confirmed by the site that the patient was last seen on in (b)(6) 2016.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6443169
• Report Number: 2134265-2017-02566
• Device Sequence Number: 19022501
• Product Code: NIQ
• UDI-Device Identifier: 08714729823759
• UDI-Public: (01)08714729823759(17)20130522(10)15353998
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 03/08/2017

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: 05/22/2013
• Device Model Number: H7493911438300
• Device Catalogue Number: 39114-3830
• Device Lot Number: 15353998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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