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

Model Number H7493911412250

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

Patient Problems Myocardial Infarction (1969); Nausea (1970); ST Segment Elevation (2059); Vomiting (2144); Chest Tightness/Pressure (2463)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was not returned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-11796.(b)(6) clinical study.It was reported that myocardial infarction (mi) occurred.In (b)(6) 2012, the patient presented due to mi and unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed on the same day.Target lesion #1 was a de novo lesion located in the mid left anterior descending artery with 99% stenosis and was 8 mm long with a reference vessel diameter of 2.55 mm.Target lesion #1 was treated with pre-dilatation and placement of 2.50x12mm and 2.50x8.00mm promus element¿ plus stents in overlapping manner to cover the entire lesion.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was located in the proximal right coronary artery with 80% stenosis and was 5 mm long with a reference vessel diameter of 3.00 mm.Target lesion #2 was treated with direct placement of 3.00 x 12.00 mm promus element¿ plus stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was found down at her home.It was reported that the patient was trying to look for her stuff while seated at the floor, but later could not get up.The reported that she also had complaints of back pain since her last fall.It was also reported that the patient intermittently experienced nausea and vomiting for 2 weeks.On the same day, the patient was presented to the emergency department (ed).At the ed, the patient also developed burning type chest discomfort on her left side, which was not radiating.Electrocardiogram showed anteroseptal st elevation myocardial infarction.However, the subject declined any interventions, hence the patient was admitted to the hospital on the same day for further care.The patient received medication in response to the event.During the hospital course, an echocardiogram revealed a left ventricular ejection fraction of 25%, grade 2 diastolic dysfunction and the physician felt that it was a poor prognosis.However, the patient chose not to undergo any intervention (cardiac catheterization).The patient had requested code status to be do not resuscitate(dnr/ dni).Four days later, outcome of the event was considered as resolved.On the same day the patient was discharged from the hospital to a hospice care.

• 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: 7081905
• MDR Text Key: 93682620
• Report Number: 2134265-2017-11794
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15526346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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: 88 YR