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	Congestive Heart Failure (1783); Death (1802); Thrombosis (2100)
Date of Event	11/23/2016
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 batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id#: 2134265-2016-11718.(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2012, the patient was presented with stable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion #1 was an in-stent restenosis (isr) of a drug-eluting stent (des) located in the distal saphenous vein graft (svg) to 2nd obtuse marginal (om) with 90% stenosis and was 10mm long with a reference vessel diameter of 3.0mm.The target lesion #1 was treated with direct stent placement using a 3.00mmx16 mm promus element plus stent, with 0% residual stenosis.The target lesion #2 was an isr of des located in the left main coronary artery (lmca) with 70% stenosis and 25mm long with a reference diameter of 2.5mm.The target lesion # 2 was treated with direct stent placement using a 2.50mmx28 mm promus element plus stent with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2016, the patient died with unknown cause.
Additional Manufacturer Narrative
Describe event or problem updated.(b)(4).
Event or Problem Description
It was further reported that patient died at home due to coronary artery disease.
Additional Manufacturer Narrative
Updated: describe event or problem and patient codes.Corrected: relevant tests/lab data.Device code corrected from (b)(4).
Event or Problem Description
It was further reported that during the index procedure, pre-dilatation was performed in the left main coronary artery.As per death certificate, the immediate cause of death was "coronary artery disease" and the sequential contributing cause of death was "congestive heart failure".Also, adjudication indicates stent thrombosis occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6181459
• Report Number: 2134265-2016-11717
• Device Sequence Number: 16378335
• Product Code: NIQ
• UDI-Device Identifier: 08714729807957
• UDI-Public: (01)08714729807957(17)20130308(10)15171523
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 11/29/2016

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: 03/08/2013
• Device Model Number: H7493911416300
• Device Catalogue Number: 39114-1630
• Device Lot Number: 15171523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 02/15/2017; 04/28/2017
• 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: 65 YR