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 Atrial Fibrillation (1729); Congestive Heart Failure (1783); Death (1802); Pain (1994); Skin Discoloration (2074); Ischemic Heart Disease (2493)

Event Date 01/07/2016

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)(4).It was reported that patient died.In (b)(6) 2013, the patient was diagnosed with unstable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion was a de novo lesion located in the distal right coronary artery with 95% stenosis and was 10mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of 2.50x12mm promus element¿ plus drug-eluting stent.Following post-dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin, clopidogrel and prasugrel.In (b)(6) 2015, the patient presented with acute on chronic systolic heart failure.Two days from the onset of symptoms, the patient was hospitalized.Medication was given to treat the event.Four days from admission, the event was considered resolved and patient was discharged on the same day.In (b)(6) 2016, the patient presented to the emergency department with bilateral lower extremity leg pain and discoloration.The patient had noticed a gradual increase in the pain mostly the left greater than right lower extremities over the past few days prior to emergency room visit and described the pain as ¿cramping and burning.¿ the patient had been taking hydrocodone for pain relief.An electrocardiogram revealed atrial fibrillation with rapid ventricular rate.Hence, the patient's medication was changed from plavix to eliquis.During the course of hospitalization, the patient was noted to be unresponsive to usual measures, and echocardiogram revealed decrease in ejection fraction.Five days later, respiratory rate and skin coloration significantly changed.Respiration ceased at 14:38 hrs.And heart rate ceased at 14:39 hrs.The patient discharge diagnosis was "end stage" ischemic heart disease with congestive heart failure (chf) (acute and chronic systolic chf due to prior myocardial infarction).The patient expired due to end stage ischemic heart disease.

• 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: 5596692
• MDR Text Key: 43270563
• Report Number: 2134265-2016-03038
• 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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15609951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2012
• 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: 62 YR