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

Model Number H7493911628270

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Chest Pain (1776); Congestive Heart Failure (1783); Myocardial Infarction (1969); Respiratory Failure (2484)

Event Date 11/19/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

(b)(6).It was reported that myocardial infarction (mi) occurred.In (b)(6) 2013, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the mid right coronary artery (rca) with 70% stenosis and was 5mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of a 2.75x28mm promus element¿ plus drug-eluting stent, with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient experienced chest pain.The chest pain persisted for half an hour and during that time, the patient took nitroglycerin, which relieved the pain to some extent, but it continued to progress.The patient's family reported that the patient was slowly and progressively having shortness of breath since two weeks ago.The patient was brought in an ambulance.The patient had difficulty with breathing and could not lie back flat without having significant shortness of breath and anxiety.On the same day, the patient presented to non-study hospital and was intubated.The patient underwent multiple laboratory examinations.The patient was diagnosed with acute respiratory failure and anemia.Furthermore, the site reported an event of non-st segment elevation myocardial infarction (nstemi).An electrocardiogram (ekg) revealed sinus rhythm with first degree av block with premature atrial complexes in a pattern of bigeminy, st & t wave abnormality, suggestive of inferior and anterolateral ischemia and rate of 73 bpm.Premature atrial complexes.The location of nstemi was not identifiable.The following day, the patient was transferred to the study hospital for further evaluation.The patient underwent repeated laboratory examination including cardiac enzymes, which were indicative of nstemi and was hospitalized on the same day.The patient became hypotensive, thus the nitroglycerin had to be turned off temporarily.The patient received heparin in response to the event of nstemi; however, heparin treatment contributed to anemia.The patient also had some orthopnea and congestive heart failure.Two days later, the patient was ventilated and two days after that, underwent blood transfusion in response to the events of anemia, acute respiratory failure and nstemi.Six days later, the events were considered as resolved and the patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6490172
• MDR Text Key: 72736184
• Report Number: 2134265-2017-03783
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729807476
• UDI-Public: (01)08714729807476(17)20130910(10)15612702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2013
• Device Model Number: H7493911628270
• Device Catalogue Number: 39116-2827
• Device Lot Number: 15612702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR