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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Infarction, Cerebral (1771); Congestive Heart Failure (1783); Myocardial Infarction (1969); Reocclusion (1985)

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-03978.It was reported at an academic conference (b)(4), that in-stent restenosis, myocardial infarction, cerebral infarction, and heart failure occurred.The aim of this study was to investigate the initial clinical results of synergy relative to the non-bsc stent.Percutaneous coronary intervention was performed to 609 lesions from (b)(6) 2015 to (b)(6) 2016.513 lesions which were received synergy stents were subject to this study.The primary end point was in-stent restenosis at follow-up angiography.The secondary end point was the incidence of adverse events including acute myocardial infarction, heart failure and cerebral infarction.In-stent restenosis rate of synergy was significantly increased than that of the non-bsc stent.On (b)(4) method, the patency rate of synergy was significantly decreased compared with that of non-bsc stent ((b)(4); x2=15.58: p<0.001).The incident rate of adverse events for one year was almost same in the two groups.

• 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: 7513819
• MDR Text Key: 108244314
• Report Number: 2134265-2018-03979
• 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
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other