MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 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 Codes	Cardiac Arrest (1762); Death (1802); Hypoxia (1918)
Date of Event	09/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
Event or Problem Description
(b)(6) clinical study.Same case as mfr report#: 2134265-2018-00107.It was reported that post a coronary artery drug eluting stenting treatment procedure, the patient had cardiac arrest and expired.In (b)(6) 2013, the patient presented due to unstable angina (braunwald classification: iiib) and myocardial infarction and was referred for cardiac catheterization.The first target lesion was a de novo lesion located in the 1st obtuse marginal branch (om1) with 80% stenosis and was 20 mm long with a reference vessel diameter of 2.5 mm.It was treated with pre-dilatation and placement of a 2.50 x 28 mm promus element plus stent, with 0% residual stenosis and timi 3 flow.The second target lesion was a bifurcated de novo lesion located in the left main coronary artery (lmca) with 60% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.It was treated with pre-dilatation and placement of a 3.00 x 20 mm promus element plus stent.Following post dilatation, residual stenosis was 0% and timi 3 flow.The patient was discharged on aspirin and clopidogrel the next day.In (b)(6) 2017, the patient was hospitalized due to cardiac arrest.The patient expired four days later and the cause of death was cardiac arrest.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the patient had expired due to cardiac arrest bought on by respiratory arrest and hypoxia.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7221264
• Report Number: 2134265-2018-00108
• Device Sequence Number: 1741708
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: 08714729807964
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/02/2018

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: 10/16/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 0015706972
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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: 66 YR