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

Model Number	H7493911412350
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	07/04/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 due to stable angina and was referred for elective cardiac catheterization.Subsequently, index procedure and coronary angiography were performed.The target lesion was a de novo lesion located in the proximal left circumflex (lcx) artery with 70% stenosis and was 10mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with direct stent placement using a 3.50x12mm promus element¿ plus drug-eluting study stent with 0% residual stenosis.On the following day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient expired and the cause of death was unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that stent thrombosis occurred as per adjudication results.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6427016
• Report Number: 2134265-2017-02292
• Device Sequence Number: 34907
• Product Code: NIQ
• UDI-Device Identifier: 08714729808008
• UDI-Public: (01)08714729808008(17)20131205(10)0015779636
• 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): 03/02/2017

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: 12/05/2013
• Device Model Number: H7493911412350
• Device Catalogue Number: 39114-1235
• Device Lot Number: 0015779636
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 03/23/2017
• 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
• Patient Age: 59 YR