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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Nakano, shinsuke, et.Al., comparison of early healing after three types of drug-eluting stent implantation using optical coherence tomography (zience/promus vs ultimaster vs synergy), oe-38, oral presentation, the 31st annual scientific meeting of the japanese circulation society.Device is 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

It was reported via journal article that stent thrombosis occurred.Early vessel healing may attribute for shortening the duration of dual anti-platelet ther­apy (dapt).Optical coherence tomogra­phy (oct) was performed 3 to 4 months after drug-eluting stent (des) implantation.Strut coverage, neointimal thickness, lumen and stent area, and intra-stent thrombus were evaluated.Fourteen non-bsc permanent-polymer everolimus-eluting stent, thirteen non-bsc biodegradable-polymer sirolimus-eluting stents, and nineteen synergy¿ biodegradable-polymer everolim.Us-eluting stents were analyzed.The average duration after implantation was 109.2 days.The synergy¿ % covered strut was 93%, the average neointimal thickness was thickest in synergy¿ and the frequency of synergy¿ in-stent thrombus was 22.2%.The conclusion reached was that the extent of early vessel heal­ing may be different between 2nd and 3rd generation des which may have an impact on dap duration.

• 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: 7475337
• MDR Text Key: 106972008
• Report Number: 2134265-2018-03353
• 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: 04/02/2018

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 Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 05/01/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other