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

Model Number H7493911438270

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Cyanosis (1798); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.  device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).

Event Description

Promus element plus clinical study.It was reported that myocardial infarction and in-stent restenosis (isr) occurred.In (b)(6) 2012, patient presented due unstable angina and myocardial infarction.Subsequently, the index procedure was performed.The target lesion was a de novo and culprit lesion for st-elevation myocardial infarction (stemi) located in the 1st obtuse marginal (om1) with 99% stenosis and was 32mm long with a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of 2.75x38mm promus element plus stent with 0% residual stenosis.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented to emergency department with the complaints of cardiac arrest associated with chest pain.The patient received one shock from automated external defibrillator for cardiac arrest.The emergency medical services noted the patient had no pulses and was turning cyanotic, and performed cardiopulmonary resuscitation after which he had spontaneous return of circulation.Troponin level was found to be elevated and the site reported an event of myocardial infarction.The patient was further referred for cardiac catheterization which revealed moderate isr of the study stent noted in the proximal of om1 and 40 to 50% narrowing was noted.On the same day, the 90% isr and jailing of stent located at om1 was treated with kissing balloon angioplasty with 20% residual restenosis.The event cardiac arrest was considered resolved on the same day.Two days after, the event non-st segment elevation myocardial infarction was considered to be resolved and the patient was discharged from the hospital.

• 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: 7274822
• MDR Text Key: 100230712
• Report Number: 2134265-2018-00893
• 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: 01/22/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2013
• Device Model Number: H7493911438270
• Device Catalogue Number: 39114-3827
• Device Lot Number: 15093715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2012
• 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): Required Intervention
• Patient Age: 62 YR