MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926238250

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

Patient Problems Cardiopulmonary Arrest (1765); Chest Pain (1776); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); ST Segment Elevation (2059)

Event Type  Death  

Manufacturer Narrative

Death date: (b)(6) 2016 event date: (b)(6) 2016 if implanted, give date: (b)(6) 2016.Device is combination product.Literature: topic 2017 conference: tough and excellent cases 5-3.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

Same case as mdr id 2134265-2017-07883.It was reported via literature that st elevated myocardial infarction and death occurred.The female patient presented to the hospital with chest pain and received a nitrite medication.Ten days later the patient experienced chest tightening, cold sweats and difficulty moving.She presented to the hospital with st elevation in leads v2-v4.Emergency coronary angiogram revealed 90% stenosis in the proximal right coronary artery (rca) and 75% diffuse and 100% obstruction in the mid left anterior descending (lad).Thrombus was found in the left anterior branch which proved acute myocardial infarction (anterior wall) onset.Emergency percutaneous coronary intervention (pci) was performed.After suction of thrombus pre-dilation was performed and a 2.5x38mm synergy stent was implanted in the lad by left radial approach.The stent was post dilated using a 2.5mm unspecified balloon at 20atm.This was successful to resume blood flow.However a large amount of collateral circulation developed in the rca from the left coronary artery, which had not been seen on the initial coronary angiogram.The patient is with dementia and refrained from placement of iapb.After 30 minutes, chest pain, dyspnea and st elevation in v2-v4 was observed again.Acute coronary occlusion was suspected.Although repeat emergency coronary angiogram did not reveal sub-acute thrombosis (sat) in the lad stent, 99% stenosis accompanied by ¿blood branch¿ was observed in the right coronary artery and urgent pci was performed.By left radial approach a 3.0x28mm synergy stent was implanted.Post dilation was performed using a 3.25mm unspecified balloon at 15atm.Revascularization of the 99% stenotic lesion with thrombus of the right coronary artery was successful.After the second pci the patient¿s breathing stopped.Resuscitation was performed, however the patient died.It was thought that after the treatment of the left anterior descending branch, and the blood flow in the collateral circulation to the right coronary artery was increased and the blood flow of the right coronary arrested by the right coronary artery was blocked and induced this episode.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6801683
• MDR Text Key: 82945966
• Report Number: 2134265-2017-07880
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493926238250
• Device Catalogue Number: 39262-3825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• 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): Death; Required Intervention
• Patient Age: 88 YR