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

Model Number H7493911416350

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

Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); ST Segment Elevation (2059); Vomiting (2144)

Event Date 07/03/2015

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id 2134265-2015-06234.(b)(6) clinical study.It was reported that myocardial infarction occurred.In (b)(6) 2012, the patient was diagnosed with st-elevation myocardial infarction (stemi) and was referred for cardiac catheterization.Subsequently, index procedure were performed.Target lesion # 1 was a de novo lesion located in the mid right coronary artery (rca) with 99% stenosis and was 8mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element plus stent with 0% stenosis.Target lesion # 2 was a de novo lesion, culprit lesion for stemi and total occlusion located in the proximal left circumflex (lcx) artery with 100% stenosis and was 12mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.50x16mm promus element plus stent with 0% stenosis.Two days after, the patient was discharged on aspirin.In (b)(6) 2015, the patient presented with two day history of ongoing chest pain associated with nausea and vomiting, and was hospitalized on the same day.Consequently, the patient's cardiac enzymes were found to be elevated and the patient was diagnosed with nstemi.Four days after, the patient underwent abnormal stress test which revealed a large anteroapical and smaller inferior infarctions with no inducible ischemia.Continued medical management was recommended.On the following day, the event was considered resolved and the patient was discharged on aspirin.

• 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: 5083967
• MDR Text Key: 26032783
• Report Number: 2134265-2015-06235
• 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
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2013
• Device Model Number: H7493911416350
• Device Catalogue Number: 39114-1635
• Device Lot Number: 15068599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 47 YR