MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK717

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

Patient Problems Fever (1858); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422); Chest Tightness/Pressure (2463)

Event Date 05/17/2013

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.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)(6) clinical study.It was reported that jailing occurred.In (b)(6) 2013, the patient had positive stress test and underwent coronary angiography, which revealed 90% critical stenosis in ostium of left circumflex artery (lcx).Subsequently, ostium of the lcx was treated with the placement of 2.75x20mm promus or promus element drug-eluting stent (des) and 60-70 % stenosis in the 1st diagonal was treated with placement of 2.5x16mm promus element des.Post procedure, the patient was doing relatively well.However later experienced nausea and vomiting, fever and evidence of substernal chest discomfort.Due to patient ongoing symptoms she was further referred for emergency coronary angiogram.Angiogram revealed patent stent (promus or promus element des) in its origin (ostial lcx), stent jails the 1st obtuse marginal branch (om1) which had a 60-70% area of long stenosis.Eleven days after, the patient presented to enrolling site for planned stage procedure in the right posterior descending artery (r-pda).Clinical status assessment indicated that the patient's qualifying condition was stable angina and the patient was referred for cardiac catheterization.Target lesion #1 was located in the r-pda with 90% stenosis, a length of 8 mm, and a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50 x 12 mm study stent with 0%.Residual stenosis.Two days post procedure, the patient was discharged on dual antiplatelet therapy.

• Brand Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• 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: 6695717
• MDR Text Key: 79348876
• Report Number: 2134265-2017-06857
• 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: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR