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

Model Number H7493911416350

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

Patient Problems Atrial Fibrillation (1729); Death (1802); Reocclusion (1985); Ventricular Fibrillation (2130)

Event Date 08/30/2016

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 the patient died.In (b)(6) 2012, the patient was diagnosed with unstable angina and coronary angiography was performed.The target lesion was an in-stent restenosis (isr) of a drug-eluting stent (des) located in the proximal left anterior descending (lad) artery with 75% stenosis and was 12mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with direct stent placement using a 3.50x16mm promus element plus stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient was diagnosed with severe aortic stenosis, was hospitalized, and coronary angiography was performed on the same day.Eight days later, the patient presented for an elective aortic value replacement for treating severe aortic stenosis and was hospitalized on the same day.Subsequently, aortic value replacement was performed and additionally, the patient was diagnosed with worsening coronary artery disease.In view of angiographic report performed eight days ago, the patient underwent single vessel coronary artery bypass graft (cabg) including the left internal mammary artery (lima) to lad without complication and the coronary artery disease was considered resolved on the same day.The following day, the patient was extubated.The following day, arterial lines and drips were discontinued and the severe aortic stenosis was considered as resolved.The following day, the patient was ambulated, was tolerating normal diet, and was subsequently transferred from intensive care unit (icu) to intermediate care (imc) unit.The following day, the patient experienced atrial fibrillation that converted to ventricular fibrillation and became unresponsive.In response to the event, arterial line was initiated and medication was administered.However, despite cardiopulmonary resuscitation (cpr) efforts, the patient expired.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that on (b)(6) 2016, the patient was coded and cardiopulmonary resuscitation efforts were continued for approximately for 1 hour; however, there was no return of stable vitals.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5996309
• MDR Text Key: 56362950
• Report Number: 2134265-2016-08812
• 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,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 15168844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2012
• 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: 66 YR