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

Model Number H7493911416220

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); ST Segment Elevation (2059); Ventricular Fibrillation (2130); Diaphoresis (2452)

Event Date 07/30/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr : the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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

Same case as mdr id 2134265-2017-10703.(b)(6) clinical study.It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the first diagonal branch with 100% stenosis and was 12 mm long with a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 16 mm promus element¿ plus drug eluting stent.Following post dilatation, residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented to the emergency room with the complaints of chest pain located in the sub sternal area radiating to the jaw, shortness of breath, diaphoresis and nausea.The patient took 325 mg of salicylate prior to calling the emergency medical services (ems).Upon arrival in the emergency room, the patient's electrocardiogram (ecg) was unremarkable and the troponin levels were normal.The patient continued to have chest pain and developed ventricular fibrillation in the emergency department.The patient was defibrillated and started on an antiarrhythmic.The patient was emergently taken to cardiac catheterization lab which revealed 100% stenosis located in proximal left anterior descending (lad) and 40% isr at the ostium of the first diagonal branch.On the same day, the 100% stenosis in the proximal lad was treated with pre-dilatation and placement of a 3.0 x 12 mm synergy stent.Following post-dilatation, the residual stenosis was 10%; however, after the procedure, a timi flow reduction was noted, from timi 3 to timi 2.A balloon angioplasty was performed successfully in response to the timi flow reduction.Four days later, the patient was discharged on clopidogrel and aspirin.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that following the index procedure, timi 3 flow was noted.In (b)(6) 2017, the patient's electrocardiogram revealed normal sinus rhythm, septal infarct, age undetermined and st elevation, consider early repolarization, pericarditis, or injury.St segment elevation myocardial infarction (mi) occurred.No stent thrombosis was noted.Cardiac enzyme elevation noted post procedure was due to original progression of mi.Four days later, the event was considered as resolved and the patient was in stable condition.

• 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: 6987113
• MDR Text Key: 90550287
• Report Number: 2134265-2017-10688
• 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: 10/11/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Model Number: H7493911416220
• Device Catalogue Number: 39114-1622
• Device Lot Number: 15154228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2012
• 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: 52 YR