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

Model Number 10622

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

Patient Problem Unspecified Heart Problem (4454)

Event Date 12/23/2020

Event Type  Injury  

Event Description

(b)(6).It was reported that myocardial damage occurred.In (b)(6) 2020, the subject was referred to cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the proximal left anterior descending (lad) artery with 90% stenosis and was 29 mm long, with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilatation and placement of 3.00 mm x 32mm synergy stent system.Following this post-dilatation was performed with 0% residual stenosis.The target lesion 2 was located in the mid lad with 90% stenosis and was 29 mm long, with a reference vessel diameter of 3.5 mm.The target lesion 2 was treated with pre-dilatation and placement of 3.50 mm x 32mm synergy stent system.Following this post-dilatation was performed with 90% residual stenosis.Two days later, the subject was diagnosed with myocardial damage and no action was taken to treat the event.At the time of reporting, the outcome of the event was considered to be unknown.On the following day, the subject was discharged on aspirin and clopidogrel.

• 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: 13285972
• MDR Text Key: 284007942
• Report Number: 2134265-2022-00376
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0024934184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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: 51 YR
• Patient Sex: Male