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

Model Number	H7493911428300
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Death (1802); Intracranial Hemorrhage (1891); Myocardial Infarction (1969); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100); Cardiogenic Shock (2262)
Date of Event	04/16/2016
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
(b)(6).It was reported that the patient died.In (b)(6) 2013, the patient presented to emergency department.Subsequently, index procedure was performed.Target lesion # 1 was located in the proximal left anterior descending (lad) with 80% stenosis and was 25 mm long with a reference vessel diameter of 3.00 mm.Target lesion # 1 was treated with pre-dilatation and placement of 3.00 x 28 mm promus element¿ plus stent.Following post-dilatation, the residual stenosis was 0%.The following day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient presented to the hospital with the complaints of severe chest pain.Cardiac enzymes were noted to be elevated and the patient was diagnosed with acute st elevated anterior myocardial infarction (mi).The patient was immediately transferred to the cardiac catheterization lab where angiography revealed 100% stenosis of proximal lad which was treated with balloon angioplasty using a 3.0 emerge¿ balloon catheter up to 12 atmospheres.Post procedural stenosis was 50% with timi 3 flow restored.During the course of hospitalization, the subject was also diagnosed with acute respiratory failure secondary to severe pulmonary congestion, acute kidney injury secondary to cardiogenic shock.Cardiogenic shock necessitated intra-aortic balloon pump (iabp).Cardiac echo revealed 15% lvef and the subject was on high risk of sudden death due to chances of going back in cardiogenic shock again.Nine days later, the patient died.The cause of death was mi.The immediate cause of death was intracranial hemorrhage.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-07359.It was further reported that the patient had stent thrombosis.On an unspecified date, a promus element plus stent was implanted in the left circumflex artery (lcx).In (b)(6) 2016, coronary angiography revealed the lad to be totally occluded in proximal portion with thrombus; distal vessel had irregularity; large branch diagonal has ostial disease of 70-80% stenosis arises within the stent.It was reported the lcx had patent stent in proximal portion and embolization of clot in distal portion, but it was further indicated there was thrombus of the lcx stent.
Additional Manufacturer Narrative
Relevant tests/lab data corrected.(b)(4).
Event or Problem Description
It was further reported that in (b)(6) 2016, the 100% stenosis of proximal left anterior descending (lad) artery was also treated with aspiration thrombectomy.The cause of death was myocardial infarction and stent thrombosis.Other events prior to patient's death were septic shock and cardiogenic shock.It was confirmed that the patient was transferred to a non-study hospital and later on was pronounced dead on (b)(6) 2016 due to intracranial hemorrhage.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6428835
• Report Number: 2134265-2017-02371
• Device Sequence Number: 16281265
• Product Code: NIQ
• UDI-Device Identifier: 08714729807988
• UDI-Public: (01)08714729807988(17)20130926(10)15661570
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/03/2017

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: 09/26/2013
• Device Model Number: H7493911428300
• Device Catalogue Number: 39114-2830
• Device Lot Number: 15661570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: 06/30/2017; 07/20/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 07/18/2017; 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: 49 YR