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

Model Number H7493911416250

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

Patient Problems Non specific EKG/ECG Changes (1817); Hyperglycemia (1905); Myocardial Infarction (1969); Respiratory Distress (2045); Diabetic Ketoacidosis (2364); Cognitive Changes (2551)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not received 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)(4).It was reported that non-st elevation myocardial infarction (nstemi) occurred.In (b)(6) 2012, the patient was diagnosed with stable angina and was referred for cardiac catheterization.On the same day, the index procedure was performed.The target lesion was a de novo lesion located in the distal left anterior descending (lad) artery with 90% stenosis and was 12 mm long with a reference vessel diameter of 2.3 mm.The target lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element¿ plus drug-eluting stent (des) with 8% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented from rehabilitation facility for hyperglycemia and change in mental status.Upon arrival, the patient was in respiratory distress and required intubation.On evaluation, the patient was diagnosed with diabetic ketoacidosis with severe metabolic acidosis and was hospitalized on the same day.The patient was treated with intravenous (iv) insulin.Subsequently, on (b)(6) 2016, the patient's cardiac enzymes were noted to be elevated and site reported an event of myocardial infarction (mi).In view of repeat troponins trending downwards, the patient was not recommended for cardiac catheterization and was treated with medication.Thirteen days after, 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: 6490872
• MDR Text Key: 72741896
• Report Number: 2134265-2017-03520
• 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: 03/28/2017

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: 07/30/2013
• Device Model Number: H7493911416250
• Device Catalogue Number: 39114-1625
• Device Lot Number: 15502980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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: 58 YR