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

Model Number H7493911432250

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

Patient Problems Arrhythmia (1721); Death (1802); Myocardial Infarction (1969); Ventricular Tachycardia (2132)

Event Date 09/01/2015

Event Type  Death  

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 Description

Same case as 2134265-2015-08626, 2134265-2015-08627 and 2134265-2015-08628.(b)(6) clinical study.It was reported that patient death occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization which revealed two target lesions.Target lesion # 1 was a de novo lesion located in the 1st obtuse marginal (om) artery extending to the 2nd om with 99% stenosis and was 15mm long with a reference vessel diameter of 2.75mm.Target lesion # 1 was treated with pre-dilatation and placement of 2.75 x 20mm, 2.25 x 16mm and 2.50 x 32mm promus element plus stents with 0% residual stenosis.Target lesion # 2 was a de novo lesion located in the distal left anterior descending artery (lad) extending to the 1st diagonal artery with 99% stenosis and was 15mm long with a reference vessel diameter of 2.75mm.Target lesion # 2 was treated with pre-dilatation and placement of a 2.50 x 32mm pe plus stent with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2015, the patient was brought to the emergency medical service (ems) for altered mental status and hypotension.Subsequently, the patient was admitted for septic shock likely from suspected c.Dificile, severe hyponatremia, acute kidney injury (aki), severe hypotension and candidal urinary tract infection (uti).The patient was placed on levophed and ventilation support due to sepsis and acute respiratory failure.During the course of hospitalization, the patient was also diagnosed with non st segment elevated myocardial infarction (nstemi) and suffered from episodes of tachycardia/ supraventricular tachycardia (svt).Events were medically treated but due to the development of gastrointestinal (gi) bleeding, levonox was discontinued.The patient was also referred to wound care for management of (b)(6) and sacral ulcerations.The patient became more septic with high fevers, elevated white blood count (wbc) and lactic acidosis.After multiple discussions with the family on the patient's poor prognosis, code status 5 was initiated with withdrawal of all medical measures.In (b)(6) 2015, the patient died.Cause of death was unknown whereas preliminary cause of death was cardiac arrhythmia.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5298972
• MDR Text Key: 33551868
• Report Number: 2134265-2015-09001
• 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: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2013
• Device Model Number: H7493911432250
• Device Catalogue Number: 39114-3225
• Device Lot Number: 15101292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2012
• 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): Death
• Patient Age: 69 YR