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); Thrombosis (2100)
Date of Event	10/11/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per product specification.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
(b)(6) clinical study.Same case as: 2134265-2017-09093 and 2134265-2017-09097.It was reported that the patient expired.In (b)(6) 2012 the patient presented with unstable angina and was referred for cardiac catheterization.Coronary angiography was performed and the patient was referred for percutaneous coronary intervention.Target lesion #1 was located in the 1st diagonal with 90% stenosis and was 10 mm long with a reference vessel diameter of 3.00 mm.Target lesion #1 was treated with direct placement using 3.00 mm x 12.00 mm promus element¿ plus stent, following post dilatation with 0% residual stenosis.Target lesion #2 was located in the proximal lcx with 90% stenosis and was 10 mm long with a reference vessel diameter of 2.7 mm.Target lesion #2 was treated with direct stent placement using a 2.75 mm x 12.00 mm promus element¿ plus stent following post dilatation with 0% residual stenosis.Target lesion #3 was located in the distal lcx with 60% stenosis and was 12 mm long with a reference vessel diameter of 3.00 mm.Target lesion #3 was treated with direct stent placement using a 3.00 x 16.00 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin, clopidogrel and ticagrelor.However, in (b)(6) 2016 the patient expired.The cause of death is unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
(b)(6) clinical study.Same case as: 2134265-2017-09093 and 2134265-2017-09097.It was reported that the patient expired.In (b)(6) 2012 the patient presented with unstable angina and was referred for cardiac catheterization.Coronary angiography was performed and the patient was referred for percutaneous coronary intervention.Target lesion #1 was located in the 1st diagonal with 90% stenosis and was 10 mm long with a reference vessel diameter of 3.00 mm.Target lesion #1 was treated with direct placement using 3.00 mm x 12.00 mm promus element¿ plus stent, following post dilatation with 0% residual stenosis.Target lesion #2 was located in the proximal lcx with 90% stenosis and was 10 mm long with a reference vessel diameter of 2.7mm.Target lesion #2 was treated with direct stent placement using a 2.75 mm x 12.00 mm promus element¿ plus stent following post dilatation with 0% residual stenosis.Target lesion #3 was located in the distal lcx with 60% stenosis and was 12 mm long with a reference vessel diameter of 3.00 mm.Target lesion #3 was treated with direct stent placement using a 3.00 x 16.00 mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin, clopidogrel and ticagrelor.However, in (b)(6) 2016 the patient expired.The cause of death is unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that adjudication indicates stent thrombosis.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6872457
• Report Number: 2134265-2017-09094
• Device Sequence Number: 495761
• Product Code: NIQ
• UDI-Device Identifier: 08714729807957
• UDI-Public: (01)08714729807957(17)20130708(10)15459119
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2017

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: 07/08/2013
• Device Model Number: H7493911416300
• Device Catalogue Number: 39114-1630
• Device Lot Number: 15459119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/22/2017; 02/05/2018
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/03/2017; 02/22/2018
• 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: 83 YR