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

Model Number	H7493911416300
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	12/21/2016
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: 2134265-2017-02236.(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient presented with unstable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion was a de novo lesion located in the mid left anterior descending (lad) with 99% stenosis and was 15 mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with direct stent placement of a 3.00 x 16 mm promus element¿ plus stent, resulting in 0% residual stenosis.Target lesion # 2 was a de novo lesion located in the distal left circumflex (lcx) with 80% stenosis and was 10 mm long with a reference vessel diameter of 2.50 mm.The lesion was treated with direct stent placement of a 2.50 x 12 mm promus element¿ plus stent, resulting in 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient expired at home and cause of death is unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that per death certificate, the immediate cause of death was acute myocardial infarction.The sequentially condition leading to the death was reported as hypertension.No autopsy was performed.No action was taken in response to the event.The patient was last contacted in (b)(6) 2016 during protocol-specified 3 year annual visit and at that time patient was doing well.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that stent thrombosis occurred as per the academic research consortium definitions.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6414403
• Report Number: 2134265-2017-02238
• Device Sequence Number: 10898492
• Product Code: NIQ
• UDI-Device Identifier: 08714729807957
• UDI-Public: (01)08714729807957(17)20131028(10)15730716
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 02/28/2017

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: 10/28/2013
• Device Model Number: H7493911416300
• Device Catalogue Number: 39114-1630
• Device Lot Number: 15730716
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 03/30/2017; 04/20/2017
• 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: 62 YR