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

Model Number	H7493911412220
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	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 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
Same cased as mdr id: 2134265-2016-10605.Promus element¿ plus clinical study.It was reported that the patient died.In (b)(6) 2012, the patient presented due to unstable angina.Subsequently, the index procedure was performed.The target lesion was a de novo lesion located in the distal left circumflex (lcx) with 90% stenosis and was 5 mm long with a reference vessel diameter of 2.00 mm.The target lesion was treated with predilatation and placement of 2.25 x 12 mm and 2.25 x 16 mm promus element¿ plus stents with 0% residual stenosis.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 reported that stent thrombosis occurred as per adjudication.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6129840
• Report Number: 2134265-2016-10604
• Device Sequence Number: 10852120
• Product Code: NIQ
• UDI-Device Identifier: 08714729807759
• UDI-Public: (01)08714729807759(17)20130515(10)0015335181
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/02/2016

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: 05/15/2013
• Device Model Number: H7493911412220
• Device Catalogue Number: 39114-1222
• Device Lot Number: 0015335181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 03/03/2017
• 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: 45 YR