MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

Model Number 10619

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

Patient Problems Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 09/08/2020

Event Type  Injury  

Event Description

(b)(6) study. It was reported that cardiac related symptoms and coronary atherosclerotic heart disease occurred. In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day. The target lesion #1 was located in the mid left anterior descending artery (lad) extending up to distal lad with 99% stenosis and was 38 mm long, with a reference vessel diameter of 3. 0 mm. The target lesion was treated with pre-dilatation and placement of 3. 0 mm x 38 mm synergy stent system. Following post-dilatation, the residual stenosis was 0%. After three days, staged procedure was performed. The target lesion #1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 84 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion was treated with pre-dilatation and placement of 2. 75 mm x 32 mm, 3. 50 mm x 32 mm and 3. 50 mm x 20 mm synergy stent system. Following post-dilatation, the residual stenosis was 0%. Target lesion #2 was located in the mid left circumflex (lcx) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 3. 0 mm. The target lesion was treated with pre-dilatation and placement of 3. 0 mm x 38 mm synergy stent system. Three days post procedure, the subject was discharged on aspirin and other medications. In (b)(6) 2020, the subject presented with cardiac related symptoms and was hospitalized on the same day for further analysis. Diagnostics revealed coronary atherosclerotic heart disease. Medication was given and non- target vessel revascularization(tvr) was performed to treat the event. The following day, the event was considered recovered/resolved and the subject was discharged.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10796583
• MDR Text Key: 215044739
• Report Number: 2134265-2020-15428
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/25/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0023764305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/05/2020 Patient Sequence Number: 1