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

Model Number H7493911416350

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452)

Event Date 07/17/2016

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

(b)(6) clinical study.It was reported that congestive heart failure was experienced and the patient died.In (b)(6) 2012, the patient was diagnosed with unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the mid left anterior descending (lad) with 95 % stenosis and was 14 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 16 mm promus element¿ plus stent with 0 % residual stenosis.Fourteen days after, the patient was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient was diagnosed with congestive heart failure and was hospitalized on the same day.Medication was given in response to the event.Nine days after, the event was considered as resolved and was discharged on aspirin and prasugrel.In (b)(6) 2016, the patient was presented to emergency department (ed) with increasing shortness of breath, swelling of leg, slight decrease in urine output and was diagnosed with decompensated heart failure.Patient's b-type natriuretic peptide (bnp) was noted to be elevated, chest x-ray revealed some vascular congestion and electrocardiography (ecg) revealed ventricular paced rhythm with frequent atrial and ventricular (av) dual-paced complexes, an abnormal ecg.Upon cardiac consultation in ed, dobutamine infusion at low dose was started and intravenous (iv) lasix was continued and patient was hospitalized on the same day.Following therapeutic strategies after few days, there was a partial improvement in patient's condition but during the later days, the patient stopped responding to the therapy and in spite of iv infusion therapy, patient's urine output was very poor with creatinine level (elevated from 2.43 to 4.80 mg/dl).There after, the patient developed significant hypotension and felt uncomfortable due to developing of cold skin, clamminess and diaphoresis.Subsequently, lasix drip was discontinued.Eventually, seven days after, the patient automatic implantable cardioverter-defibrillator (aicd) was turned off and the patient was noted to be in end stage heart failure with a very poor prognosis.Two days after, hospice care was initiated for symptoms control.During the hospice care, the patient's upper elbow and lower elbow turned into ashen color with respiratory rate @ 1-2 breaths per minute.On the same day, the patient expired due to congestive heart failure.Per death certificate, primary cause of death was acute systolic congestive heart failure and underlying causes were chronic kidney disease and hypertension.

• 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: 6421352
• MDR Text Key: 70480862
• Report Number: 2134265-2017-02380
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729808015
• UDI-Public: (01)08714729808015(17)20130503(10)15303434
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 15303434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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; Hospitalization
• Patient Age: 83 YR