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

Model Number	H7493911420300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that following a coronary artery drug eluting stenting treatment procedure, the patient expired.In (b)(6) 2012, the patient was diagnosed with unstable angina (braunwald classification: iiic) along with myocardial infarction and was referred for cardiac catheterization.The target lesion was located in the proximal to mid left anterior descending artery (lad) with 80% in-stent restenosis of an unknown stent and was 20mm long with a reference vessel diameter of 3.00mm.The target lesion was treated with direct placement of a 3.00x20mm promus element plus stent, with 0% residual stenosis.The patient was discharged on aspirin and clopidogrel the next day.In (b)(6) 2017, the patient expired.The immediate cause of death is unknown.
Additional Manufacturer Narrative
Event date corrected from 06-sep-2017 to (b)(6) 2017.(b)(4).
Event or Problem Description
It as further reported that per the death certificate, the immediate cause of death was intracranial hemorrhage and other underlined causes of death are severe encephalopathy, ischemic cerebrovascular accident(cva) and chronic obstructive pulmonary disease (copd).

• 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: 6930213
• Report Number: 2134265-2017-09576
• Device Sequence Number: 1443764
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: 08714729807964
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2017

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: 03/25/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 0015217625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/29/2017
• 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
• Patient Age: 49 YR