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

Model Number	H7493911438250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	03/18/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the complaint device was not received 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
Same case as mdr id: 2134265-2016-11027 and 2134265-2016-11028.It was reported that the patient died.In (b)(6) 2012, the patient presented due to unstable angina and coronary angiography was performed.The target lesion was a de novo lesion located in the proximal right coronary artery (rca) extending up to the distal rca with 100% stenosis and was 110mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50x38mm, 2.75x38mm and 3.5x38mm promus element¿ plus drug-eluting stents in overlapping manner.Following post-dilatation, residual stenosis was 25%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient expired.The cause of death was unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the patient death was confirmed as a cardiac event and possibly stent thrombosis.As per adjudication.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6149632
• Report Number: 2134265-2016-11026
• Device Sequence Number: 16362890
• Product Code: NIQ
• UDI-Device Identifier: 08714729823735
• UDI-Public: (01)08714729823735(17)20130213(10)15121661
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/15/2016

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: 02/13/2013
• Device Model Number: H7493911438250
• Device Catalogue Number: 39114-3825
• Device Lot Number: 15121661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 03/09/2017
• 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: 79 YR