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

Model Number H7493911320300

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

Patient Problems Cardiac Arrest (1762); Death (1802); High Blood Pressure/ Hypertension (1908); Ventricular Tachycardia (2132); Heart Failure (2206); Cardiogenic Shock (2262)

Event Date 04/03/2015

Event Type  Death  

Event Description

It was reported that hypertension, ventricular tachycardia, cardiogenic shock, heart failure and death occurred.The patient presented with acute anterior wall myocardial infarction (mi) with a blood pressure of 90mmhg.Vascular access was obtained via femoral artery.The 18mmx3.00mm, 80% stenosed, de novo, concentric target lesion was located in the non-calcified and non-tortuous left anterior descending (lad) artery.After a non-bsc guide wire crossed the lesion, the patient developed an arrest and was revived by cardiopulmonary resuscitation (cpr).Pre-dilatation was performed with a 2.00x10mm balloon catheter.A 3.00x20mm promus element ¿ stent was then implanted in the lesion and the physician noted that the patient was hypertensive.In addition, the physician noticed another lesion located in right coronary artery (rca).While the patient was in shock, a non-bsc stent was implanted in the rca and the procedure was completed.Four hours post procedure, the patient had cardiac arrest and ventricular tachycardia (vt) was noted with hemodynamic compromised.Advanced cpr was performed with multiple shock given and vasopressors were administered.The patient died.The cause of death was extensive acute anterior wall mi with cardiogenic shock with severe heart failure leading to sudden arrest.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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).

• Brand Name: PROMUS ELEMENT ?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4736106
• MDR Text Key: 5824740
• Report Number: 2134265-2015-02537
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: H7493911320300
• Device Catalogue Number: 39113-2030
• Device Lot Number: 17514494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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
• Treatment: GUIDE CATHETER: 6F EBU; GUIDE WIRE: RUNTHROUGH FLOPPY
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 75