MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Device Problem Activation Failure (3270)

Patient Problems Angina (1710); Chest Pain (1776); Reocclusion (1985); Obstruction/Occlusion (2422)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

Fast feasibility study clinical study.It was reported that the stent was under expanded,stent jailing occurred and the patient experienced chest pain.In (b)(6) 2015, the patient was presented with stable angina and abnormal stress test or imaging stress test indicating ischemia prior to procedure the subject was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the mid right coronary artery (rca) with 80% stenosis and was 12 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.0 x 16 mm fast scaffold.Following post-dilatation, residual stenosis was 0%.The subject was discharged on dual antiplatelet therapy.In (b)(6) 2020, the subject presented with complaints of recurring chest pains with decreasing anginal distance followed by episode of rest pain.The subject was treated with gtn patch and was admitted for further cardiac monitoring, observation and management.The subject was currently taking aspirin and clopidogrel.One day after, coronary angiogram revealed, possible ostial stenosis in the left main coronary artery.In the left circumflex artery, a large caliber with minor disease and rca with mild proximal disease.On the same day ivus imaging from mid-distal left anterior descending artery (lad) showed minimum lumen area of 2.64mm2 with an atheroma burden of >70% and luminal stenosis of 80%.There was significant luminal calcification that did not extend for more than 180 degrees or more than 5mm length.The ivus images indicated more disease in this segment than angiography.On the same day, the ostial stenosis in lad was treated by pre-dilation with 2.50 x 20mm nc balloon and subsequent placement of 3 x 20mm synergy stent in the mid distal segment and overlapping with the previously implanted proximal lad stents.Follow up angiography showed no complication, however under expansion in the proximal segment of the stent was noted.A 3.5 x 12 mm nc balloon was used to post-dilate the entire stent to a maximum of 16 atm.Post this a repeat ivus was performed that revealed excellent strut position, however still some proximal and distal under expansion.Then a 3.75 x 8 mm nc balloon was then used to post-dilate the entire stent again and follow up angiography revealed good stent expansion, however jailing in in 1st diagonal was noted.Though timi flow was noted to be 3, the subject experienced significant chest pain.Then a 2.0 x 12 mm balloon was passed through the lad, stent struts into the diagonal side branch and dilated to 8 atm for 1 minute.Final angiography images revealed no further ostial stenosis.The chest pain had also resolved.There was no evidence of dissection or flow limiting stenosis in the diagonal artery.A repeat ivus was performed that revealed excellent stent strut apposition, however some proximal and distal under expansion.In (b)(6) 2020 the event was considered as resolved.On the same day, the subject was discharged on dual antiplatelet therapy.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10978392
• MDR Text Key: 220525644
• Report Number: 2134265-2020-17253
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2020
• 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
• Patient Age: 70 YR